Review of reflux reasons, terminology, data card setup and calibration, and the importance of educating the patient of diary annotation.
Yeah. Yeah. Mm. Yeah. Mhm. Yeah. Yeah. Welcome everyone. Diversity healthcare is excited to present our latest webinar series reflux studies from start to finish. I'm General Schmidt, the marketing director here, diversity health care and I'll be your host today. Today's topic is significant terminology and proper probe placement in a reflux study. Our speaker for the series is Jason baker. Jason is the co motility director and director of clinical research at atrium health in charlotte north Carolina. He frequently presents a national and international annual scientific meetings and is an elected council member for the american narrow gastroenterology and motility society. This webinar is being recorded so your microphones have been muted. Please send your questions anytime via the questions boxing or go to a weapon. Our panel. We'll do our best to answer all the questions at the conclusion of the presentation for those individuals that did not get their questions addressed. We will respond once the webinars over the recording for this webinar will be uploaded this week to diversity Tech university for you or your colleagues to access in the future. I'll now turn it over to Jason. Yeah. Thank you, Jenelle. Welcome everybody this evening and very excited for you to join us in this third series of the webinars and the previous ones we look to be explored to stop the geometry. The second one we exploding erectile manama tree. And now we're going to explore um as an inventory reflex testing through this next uh this webinar. So so for objectives tonight we're going to look for reasons for reflux. We're gonna look at what actually what is impudence. We're gonna review ambulatory reflex terminology which is very important to understanding the science behind the laboratory reflex testing. We're gonna describe the proper setup for with the data card and calibration of the the catheter and the probe itself. Then we're going to look at the impact of educating patients about proper diet diary annotation regards if you're using the recorder or paper diary. So the reflex testing algorithm on or off as the suppression therapy. This is kind of a general type of algorithm. Individual sites may decide to do differ by you know migrate from this just a little bit and in theory reflex testing kind of follows this algorithm on the right left hand side you see. So there is some evidence through an endoscopy some atypical symptoms. They've had a prior anti reflux surgery or they have recurring persistent of symptoms on P. P. I. Or after surgery. You might want to do a P. P. I. Uh ph tests after off PP. I. Either wireless or catheter based. But on the right hand side of the screen you see there is some evidence through endoscopy. Um or they've had a prior ph testing that may have came back positive. They were put on athletes suppression medication. And then you might want to move towards an impedance ph test easy on double dose P. P. I. Or some kind of combination of a suppression medication. So recommendations or preparations by the Leone consensus, Leone consensus was a international consensus group of leaders of related to reflex from all around the world they meet um every so often you know update the consensus. But these are this is the recommendations for the preparation by them that most labs or most facilities tend to follow today. So for ambulatory reflex monitoring done off P. P. I. P. P. I. Should be held for at least seven days prior to the study, Patients should be instructed to be nothing for 46 hours prior to replacement of the Catheter. The six hour mark comes from really from the gastric emptying literature or basically primarily all people will have that don't have cash or deputy issues will have stuff that empties out of their stomach beyond into their small tests. And At least at the six hour mark, I want to really try to protect from aspiration and vomiting. So that's the reason behind that with diabetics. You know, you might want to encourage them to get up, you know, around that seven hour mark and have something like maybe like scrambled a something a little bit of protein just to maintain your um, you know, blood glucose level. Um during inventory, reflex monitoring patients should maintain their regular activities. You definitely don't want them just to go home and watch Tv or sleep all day or don't do whatever they normally do should highly encourage them to maintain whatever they may be doing. Like if they can go to work, go to work, you know, do a little bit of exercises. But to protect that gala recorder south, You know by some kind of means. I put it under a sweatshirt or something like that. But doing really encourage them to see what a true representation for a 24 hour period looks like it is recommended to have only those sips of water occasionally between the meals. We don't want someone sip sip, sip all day on some fluid or graze all day. Like you know, graze graze all day. You want them to have their meal or drink and 34 hours later have another meal or drink. But in between they can sip on some water or chew on some ice chips. Patients should keep a diary. This is gonna be really important. We talk about this at the end of this woman are but when they're upright, when they recumbent, that just means when there and their supine or better position when you eat meals. And when um they are experienced their symptoms that led them to have this test. So reasons for reflex. There's there's multitude reasons for reflex. There's some of that provoking factors and the perception of reflex you see on the left hand side, the characteristics of reflex. You know, this citizen. How far is emanating from the belly into the esophagus and how far in the esophagus is moving up into the esophagus column, there's gas reflects. There's also reflex that happens from the pile oris um in the duodenum, through the pillars into the stomach that may emanate uh into the esophageal column and on the right hand side there's there's really peripheral sensations like so from Nikos integrity. So basically it's the reflexes moving back into the esophageal from the stomach into the esophagus causing this you know, sensitive area may be expressed some symptoms. This arpeggio clearance. It's just not after it moves from the stomach into this office, it's just not having it. There's not enough resources to push it back down, then there's gotta hernia. You got low L. A. S. Pressure, increased the sensibility E. D. J. Just means it's wider. It's not tight as tight. Then this acid pocket generally refers around the coast perennial face and is represented in delayed gastric emptying and also obesity. Obesity is becoming more important relative to uh the presence of reflex as uh as time goes on. So the first one we're gonna look at is just to hide a hernia for a cause of reflux. As you see, the definition really is this the upper stomach region migrates through the esophageal hiatus resides within the chest cavity. So if you look on the right hand side you see the diaphragm keeping keeping that pinched off the stomach, it's not migrated into that highlighted sack and that that create a nice tight seal. But on the bottom one you see the haida hernia, you see that now the diagram gets a little loose, that there's a ligament there, it also gets a little loose and now more of the stomach is starting to move into this highest back into um the esophageal region. So low L. A. S pressure. This is really important, especially um doing a soccer geometry before ph testing, there's a lot of metrics you can measure to give you some evidence why someone may be having these as acid reflex shirt, a greater percentage of acid reflux over time. So the definition is really to add the L. A. S. Is really the L. A. S. And the cruel diaphragm and acts as a barrier as a function. So basically anything it stops or anything emanating from the stomach and the esophagus. So the resting tone of the L. A. S. Is important how long the length of the L. A. S. Import is important because at all. That represents how much strength that is basically staying tight. Now allowing stuff to emanate up, then up in the separation of the L. A. S. And the cruel diaphragm starts to happen. It means that barrier gets a little bit more weak and not as strong to block and stuff moving from the stomach into the esophagus. So transient, lower esophageal sphincter relaxation or TLS. Er you may see this a lot in the south of manama trees and encourage people to review the south geometry webinars because this becomes really important. Should be documented during the south of manama tree because it is really one of the top predictors of reflux. So um if you see this on a stop geometry, you should actually report this on the note itself because especially if they're having a ph test after it because it could give you some evidence why they may be having um the reflux, higher percentage of reflex. So TLS er is defined as the lower esophageal sphincter relaxation that is induced spontaneously without swallowing and shortening of the safia. So basically after the swallow happens you'll start to see stuff pressure add up here and stuff start to emanate back into the stomach into the esophagus. And generally there's people have this reserve repair services reserve, it will have this kind of augmented pressure contraction and push it back down. It's almost like a natural defense mechanism, but often it's week for people who have gastric reflux disease and that means there's more exposure time in the esophagus because you don't have this natural defense mechanism to push it back down into the stomach area. So acid pocket. This is this is really important when you're doing your pretest homework. Is that one of the tests that you should look at? You know, you look at the upper end of the recent upper endoscopy, the clinical note if they've had a variant swallow, but you should also look at they've had a gastric emptying study. Because this gives you some evidence for potential why they may be having uh greater acid exposure time during their ph test. Because really acid pocket is the definition is an area of a buffer gastric acid that accumulates in the proximal stomach after a meal. So, you see on the right hand side of the cartoon, you see this is this is basically post perennial. You get this ph generally goes up and starts to come down and more of an acid level. But then this is pocket starts to grow up here and eventually if this this basically this this squamous calmer junction or the Z line becomes a little weak, it will basically have this acid pocket will become exposure of acid in the esophagus body. So over here on the left hand side, if you see the stomach is down on the bottom end, the esophagus is on the top end with like the Z. Line at this black level right here during fasting state. You see the stomach that it's you know, it's acid base, uh intra gastric acid base. But after a meal it starts to buffer out where the ph goes up. And you can kind of see a little bit start to flash up into the esophagus body. But it's it's a ph greater than six. Then about 15 plus minutes later you start to see this acid pockets start to um start to emerge right here. By the buffering is in the injured gastric in the stomach area. 45 minutes later, you start to see an increase of lower ph 40, about 48 minutes later, you see this reflex event in this cartoon on the left hand side is depicting someone who has heard and then about you know, our our 15 minutes later that you see an inter gastric started to come back to its acid level. But you still have this acid pocket right here. And these are kind of common for people who have really gastric emptying. So reading it makes a lot of places have this test before the ph test but at least having some evidence for especially if they're diabetic or have evidence of gastro priests. So so far joe clearance. So we did this study sometime back. But with the Chicago four point oh now really esophageal motility is characterized by um This is ineffective motility is characterized by um A. D. C. I. Lower than 450 but greater than 170% of the wet swallows collected during the south of manama tree. As you see on the bottom this this one on the left hand side is I am honor off P. P. I. And as you see as the percentage goes from 50 60 70 80 90 you see the number of reflex defense tend to increase. But then on the right hand side people are off P. P. I. As the number of ineffective swallows occur, especially when you get that 70% mark and greater. You see the acid exposure time increased. So when you're doing this south option, you see a lot of ineffective swallows and they're doing a ph test after it. Maybe some of the reasons why if they do come back with higher acid exposure time that they may. Um The reasons for their gird itself, delayed gastric emptying. And we kind of talked about a little bit of delayed gastric emptying of styles and liquid from the stomach. That's that's what we're talking about. We're talking about delayed gastric emptying and it's relative to reflex because it may induce those transient, lower soccer geospatial relaxations. It may induce that acid pocket. But you see over here on the right hand side, I'm just going to concentrate really on acid exposure itself. And normal people on normal gastric emptying into delayed gastric emptying. You see the people of delayed gastric emptying have much higher medium level of acid exposure time. Even the outliers are quite higher than people with normal um normal gastric emptying. So what is impedance? You know, sometimes it's abbreviated with safe to see that, but it's really measured in homes and you know, before we move onto this, Is is there anybody anybody have any questions on the reasons for potential social reflux? I do have one question our studies done mostly on or off TVs. Mhm. Yeah, it's it's a little bit of lab dependent. Um And it also has to do a little bit with their history beforehand and their evidence through the endoscopy. Have they have they had a prior test, But I don't it's not so much as they've been mostly done on or off. I think it's where the patients at in their reflex journey. And also are they trying to do that? Trying to assess if the acid reduction medication is working or if they need to be put on acid reduction medication. So it's a little bit about the patient itself and also the labs of Strategy plan um for reflex testing, if anybody has any questions is please type them in and we will answer and try to answer them as we go through um through the webinar. So again, what is impedance is abbreviated as easy? It's measured in homes. So This is a basic catheter when you're talking about doing impedance ph testing, there's usually a look down at the bottom up here at the bond is usually a gastric sensor, then there's an esophageal censor. The separation here is about 15cm. Um and so this one is about five cm north of approximately s and this one is about 10 centimetres below the approximately S. Then you got this impedance channels or six impedance sensors and they're separated um by different centimeter marks to below the uh video ph sensor to above. Then you start to get proximal one's a little bit higher too, especially if you're measuring the proximal extent of how far stuff emanating from the stomach into the esophagus. But this is uh this is a very common impedance ph probe itself. So impedance technology, you know, the bowl is conducts electricity and the flow goes from one sensor ring to the other sensor. So if it's if it has a lot of impedance, you'll see it had more resistance go from one ring to another, one sensor to another. So some terminology with inventory reflux. This is really important because again, that same Leone consensus has uh kind of really defined these in three different categories. The main two we're going to keep our eye on is this total acid exposure time? And we're also doing a number of reflux episodes itself. So total at the exposure time is basically the cumulative duration time. The video ph is less than four at the distal sensor of the esophageal ph sensor In the esophagus body expressed in a percentage. So they break it off in three different thresholds less than 4 um Throughout the 24 hours that they're doing this stuff, it's just physiologic are normal, common occurrence, you know that someone may have, Then you get greater than six of the time that they have an acid exposure time in the esophagus less than a ph of 4.0, this is pathologic. This is really good evidence For dirt itself. But when you get in this 4-5.9996 level. This is borderline inconclusive. So now you need to really look for some other um um add junk evidence for to someone who may may have GERD. So the other one strong evidence as far as this number of reflex episodes. So it's the frequency of occurrence of a reflex episode. Um throughout this, throughout the test. So like less than 40 of these is this physiologic kind of common occurrence throughout someone's normal day. It doesn't have good, you get above 80 of these. This is an elevated to mark. So it gives you a little bit more, it gets you more evidence around total acid exposure time to say it's elevated and it's really, really good evidence for GERD itself. And you get that 40 to 80 you get this borderline and conclusive thing again, then the next two are these these association probability. So the two that are most common. There's one a little bit more rigorous and another and we'll talk about a few more slides down the road about why there is a little bit more rigorous but they should both be reported. But they both do something a little bit different and gives us some evidence and an adjacent to the total acid exposure time in a number of reflux episodes. Then there's some novel metrics. Now this mean national baseline. It's basically three separate measurements during sleep to see how if they have any resistance or stuff moving from the stomach into the esophagus while you're sleeping. Then this post swallow Paracelsus wave. It's something that happens about the take TSL er remember it has after you have a reflex episode impedance phs and shows that there's this this way that pushes the stuff back down into the stomach and doesn't allow it to sit in the south of your body for a long period of time. So again, really the conclusive evidence for pathological reflexes, you know, acid exposure time greater than six. The borderline is you know, 4 to 6 with reflex episodes 40 80. But some adjunct or supporting evidence is when you have this this greater than 80 associated reflex episodes and you can start looking at symptom index and then association probability along with this mm V. I. P S P. W. To give you a little bit more adjunct evidence when you're reviewing these tests. So there's going to put both these up here now and talk about a little bit about what these are. So you see these commonly on every report sort of symptom index or S. I there's a number of reflex-related symptoms by the divided by the total number of symptoms episodes, times 100 gives you a percentage. So if you think about it, the denominator is really a big thing here. So if you have Someone have 100 you need to get the 50 because the thresholds 50 or higher. So you need to get the 50. But if someone has four, you only need to get the two or someone has to, you only need to get the one. So it's a little bit less rigorous, but it gives them strength, especially when the association is symptom association probability or S. A. P. Is like this thresholds 95%. Let's say you get this 80 85%. This S I will give you a little bit more uh the edge of evidence to the S. A. P. But the S. A. P. Is really um almost by chance it's a. Four by four table. It really takes all the possibilities of chance out and if you have greater than 95% then it's really highly associated with that symptom and reflects being present at that time. So the dmitry score is a legendary score. You've seen it almost on every report. It kind of pre populates and almost every port. And it's it's very well known but it's a composite score. So it's very hard to hand calculate. But the composite parameters of the score is It's all these six. It's total number of acid Reflex episodes. The percentage of total time below four. The percentage of total time in the upright position, below 4% of total time. And the recumbent or supine position below ph four point oh the number of reflex episodes greater than five. So extended ph events greater with a ph lower than four point oh. Then also the longest reflex episode in minutes. So this is a composite score and anything lower than 14.7 is considered normal. However when they when they created this composite score just to keep in mind when they created the composite score, they did this study on it was developed for people off PP. I. Study so there hasn't been really done anything on PP. I. Study. So I would take the the Minister composites go a little bit of grain of salt. Probably use more of the Leone consensus metro especially on people on PP. Um acid suppression therapy. The bottom the cartoon on the bottom the a. This is a dual sensor ph study. There's the four point overline kind of runs through the middle of each one of these ph strips. But you see there's no at no evidence of pathological grief, like no prolong evidence. You see the purple hue here, that represents a meal. So usually the software will omit those meals because most of most of diets are just uh blow ph four point oh B. You can just prolong recumbent position. You see as this yellow is. When there They reported that they were in the recumbent or supine position. You see elongated episodes of uh reflex uh moving stuff moving from the stomach and the esophagus below 4.0 p 4.0. See in the upright position there's the limited reflex events in the upright position. You can see them in between meals. And then D. Here is that poor clearance. As you see, it's kind of moving from the stomach and the esophagus. And just kind of standard, it's not really push back down. So this good evidence, good strip of poor clearance of this reflex occurring. So they're not turn the main nocturnal baseline or mm. B. I. Um is basically extracting the average baseline and penis values that stable nocturnal events in 10 minute epochs of time when you're sleeping. So this is it takes a little bit of editing. We'll look at this a little bit um next week. Is that sometimes you get this undulating waves when you look at you want to make sure it's somewhat of a quiescent area. You may have to do some little bit adjustments. But the big thing is that the distal softened you on the FBI is negatively correlated with acid exposure time. So what that means is that As a resistance goes down, so showing that there's more stuff, you know, uh represents more reflux or stuff coming back up. The the acid exposure time increases. So and then the normal threshold and in the literature right now is uh normal is greater than 2292 arms. So the post wall and use peristalsis, waiver, P. S. P. R. P. W. This is what we were talking before. And if you look at here a there's no event happening at all, basically errors is kind of floating across the cat penis ph catheter here and I know over in the left hand side, you see the number of homes and this represents the p the the impedance channel by that C. C. Represents impedance. Then you've got the ph strip itself. And here you see a reflux events happening. Remember as a reflex bypasses one sensor to the other. You see the depression of greater than 50%. And as it bypasses it, this is the entry point. This is the exit point, It goes across at least two channels and this is approximately getting up further in in the column beyond nine and 9 cm. But then right after that, you see this this post way that's pushing stuff back down. You can see the directionality. So especially if you have someone who did it south of manama tree and an impedance ph test. And you see a lot of TSL er especially if you if you do different positions in the south of manama tree, you might want to keep your eye out on these type events. Um when you're looking at impedance ph D s. So before we move onto the set up, um is there any questions about, you know the first section, the section second section of the Webinar so far? Yes. Um I have an inquiry about whether or not you think that the domestic score will be abandoned of our interpretation Of 24 hour ph monitoring according to Leon Consensus. Wow, that is that is a fabulous question. Um I would say this is just my opinion. I haven't read this anywhere. So this was just is my opinion. I think um as time goes on to leo consensus as other consensus um for gi motility diagnostic testing and physiology diagnostic testing. As these consensus groups and these international groups come together more and more and more. I think they're gonna they're going to challenge traditional theories with new innovative technology to see what metrics actually are. The key metrics for assessing pretest probability for reflex or any type of testing and to see which ones are stronger than others and ones that may not be as useful. So I think there's a possibility with new innovation and new technology, I think all traditional metrics will be challenged to see the rigor of those, um, those types of metrics and actually assessing for what assessing like reflex itself. So that's a good question. I think I would be very intrigued to read that if someone wants to do that because I think that's a question that needs to be answered. All right. How do you interpret when a tracing goes way above and crosses into other channels, For example, and then when the Penis is 99 99. Yeah, I say I would say I don't see that very frequently. Um, you can adjust the range a lot of times, but if it gets out of range, um, there's not so much you can do about that, but you can do some adjustment on the home range itself. Generally, I see a lot of it has been um, if you do, especially in pediatrics a lot of times, I see it with impedance channels. Get into the fairness, in the airway, you know near the airway, see a lot of air going across that in the back of the throat. But I don't see very much of that in the adult world per se. So I would say it just arrange a little bit, see what you can do and then see if the catheter was placed actually accurately. I'm good question though. Really good question. All right. You gotta give him credit for I think. Uh huh. All right. We'll start to look at the set up of the card itself and the and the software to get to prepare for a uh penis ph test. Because it's really important to set up is critical to, you know, collecting really high quality data. And there is there is a strategy of going through this and it should be followed each and every time. So when you open up the software, you kind of see this this board right here. Um There's these little since carbs, you put this in the sim card reader, um and then you're gonna you're gonna click on right here as it circled in the red oval open patient management. So then you're going to get this page that comes up. The most important thing is you see, you see the red asterix right here, there's about five or six of the five or six of them. Those are the only ones that are mandatory to be populated for you to move on. But I think it's really important to kind of feel it all in. It helps you archive studies that help you find study, especially if you're an academic institution helps you. Clinical research is all kinds of different reasons why you want to do it. It's really important for educating, especially uh allied health professionals, fellows, medical residents, visiting professors and such. So it doesn't take much time. But I would highly recommend you feel all these in um itself. But um, so you want to put in the demographics, you know their name and all that type of stuff. The common type of thing. You want to select the work for appropriate for a pro model being used. So you want to write here to workflow itself. You want to choose the right workflow each each most of time. Each, each catheter probe itself will have a number. So you wanna make sure that's the right number you want to indicate if the patient's honor as the suppression therapy during the study. This is really important because especially um you know when you're, when you're reading the testes could give you some idea like we just talked about the police or score that type of thing. So you want to know if they're on or off it. Um, you want to fill in any additional fields. Like I would highly recommend you feel all these in. If you possibly can, then you're going to save the changes, then you're gonna select setup card. Okay then let's say for example, you had your, you know, your, you had big Bird just did the last study and you're trying to put in superman that you're going to get this window comes up and then you, you wanted to says would you like to continue or delete the existing study on the car? So I would highly recommend to get a flow when actually when the study gets back, it's either tape to the diary or somewhere and everything is downloaded either immediately or at least that day. Um um to make sure you don't kind of lose anything. So it's really important to know that that study prior was downloaded before you move on with this, uh moving forward, but uploading a new patient for that since card. So then this window comes up you say yeah, you see what all the information you kind of populate in the first window. Then these buttons are disabled. So you can either select to disable the buttons. You don't, you don't, you're not going to let the patient touch them himself. And they're going to do all diary paper annotation or you're going to allow them to touch the buttons and then not do the diarrhea or you can do, you have to do both. If you're going to let them touch the buttons you need to populate what number one? Number two. Number three. So the buttons are a little bit bigger. One is bigger than two and two is bigger than three. So basically we're saying number one is their primary symptoms. So we'll say this window comes up and you can put in whatever their primary is and that will basically populate the one the two and three. Often if you allow patients to talk about this they're going to have a lot more than three symptoms but you really want to key in at least the top three because diary annotation is gonna be important, remembering is going to be important. All that type of thing. So concentrate on the top three. These recording options are pre populated. You can select if you want them to view the ph recording or not. Review. That's more of a lab strategy model. Um Itself. Sometimes patient will concentrate on the data recorder. Sometimes they won't um may help for people if they're on call with this but help troubleshoot but either way that's up to individual labs to do and then the patient identifier on the screen itself will be by name. I've had the recommended, keep it by name or other and come up with a studied name. But I would rarely rarely don't put patient medical record number on there. So after these shows like chest pain and throat clearing those were the top two. That's all they had. Um then you can go on and hit OK and Save two cards. Yeah. Alright. So now we're ready to set up a couple of things you need. You need that you're going to connect the probe to the recorder, you're going to insert the sim card into the quarter and always use two brand new double A batteries. Don't reuse batteries. Always use two brand new double A batteries. So it's on the left hand side. You see the record yourself, you see a image of a catheter itself. Is the screen. We'll just we'll read basically when you put the the sims card and card file reading configuration you can see a lot of looks like computer language kind of going across the display screen itself. Once this is complete disgrace, the display screen will show basically the patient's name or your other identifier for them. The Pro protocol selected and then the pro model inserted. So if if they should all match like 44 it's 44 catheter. If you say pro 44 on the screen the next thing that we're going to screen will display. You're going to calibrate start procedure, diagnostic set up for standby. So um if you need to work through some of these different things but mostly actors set up is set. You won't have to do very much of that. Basically concentrated on the calibration process itself. So calibration will be highlighted like enable them each probe must be calibrated prior to every study. So these aren't recalibrating, must calibrate them prior to study and there is a process of doing this correctly. So the calibration buffers are four and 7 and the impedance sensors are verified within this calibration faces. You see on the right hand side you see the calibration setup itself, the data recorder, a couple brand new double A batteries. The blue little since card the next thing next citizens cars, the card reader itself and then the satchel that the cat the data recorder will remain in. Why they're doing the test. So some pearls to calibration. It's an internal reference so there's nothing there's no external reference that has to be calibrated. Um you want to pre soap probe in the buffer solution for at least 10 minutes prior. Um Don't pre silicon water. Um do calibrate just prior to the program starts at least one hour before you're going to do but closer to right before you're doing often I teach is that you get done with the south geometry than than most we do is we'll move on to a ph uh study and we basically calibrate right after the Asafa geometry. And during that 10 minute period we can actually talk about the diary. It's a good time or it's nothing really going on. Uh So there's a good time to spend a lot of time discussing the diary itself. The buffer do use fresh buffer, make sure it's not expired to use fresh buffer each day. Um don't pour buffer back into the containers after the day is over. Just pour it down the sink, uh stored at room temperature at the room temperature and never refrigerate the buffer solution itself. So some patient instructions. This becomes very important for both for the allied health professional performing the study and also the higher rigor of the test test results itself because it's really this partnership that's happening between the allied health person and the patient undergoing the test. So there's a paper diary. So you know, it's really a strategy plan from each individual labs. I know people just use paper, I know people just use the data record herself and I know also people who do both. So um as you see, there's this common documentary here, you can document like this chest pain and throat clearing that what also this allows the patients that they you know had so much kind of given to them. They go home. They need to know what each one of these icons are. There's a there's a description of what each icon is then the diary entry itself and it's used and you have to use the diary at the time on the data recorder herself to match up with the entries and not use your I watch your iphone or just a regular cloth. So some patient instructions and this is really important. You know, they're not allowed to get the data recorded wet so there's no bathing or showering during the test. Um I don't even recommend not even using a lot of people use those little uh whites. Now I tend to tell stay away from that depends what type of tape you use. Um We've used tag terms so it's really sticky but you kind of wanted to use the kids kind of where off the adhesive this so you know what no bathing or showering during the test really haven't not eat gum or suck on hard candy because that also may produce more reflex just by that natural body mechanism of this. This agent going down through the esophagus into the stomach and also creates stomach physiology when you're chewing on hard candy or gum. Do you want to really encourage them to continue normal activity? You know eat whatever they normally. So they Mcdonald's three times a day. Mcdonald's three times a day. It's like a vegan like a vegan whatever it may be. Do not do not deviate from whatever they normally do because of this a little bit of an irritant having this catheter And then for 24 hours. Really encourage them to do that. Don't go home and just take naps or watch TV. You know do whatever their normal activity is. The grocery store and the grocery startech thing. Sleep as flat as possible. Um I would say this this is a little bit of a tricky thing because some people who already have had some evidence of GERD they've been now sleeping on an incline or a good pillow or a good bed good wedge all these different products now so but as flat as possible trying to really encourage them to sleep as flat as possible and then record symptoms by either pressing the data, record itself, writing on the diary sheet. Um and try to be as exact as possible. Don't if they feel it, have them recorded or hit the but don't have them try to do it by memory so really be as accurate as possible. Um You want to keep the dad record on your body at all times. It means you got to sleep with it on um that type of thing. So warned them ahead of time, they had a sleep at machine. They may want to make some adjustment because the catholic kind of not allow the thing that section completely to the face up, make sure they're where they're gonna be sleeping with this on and that type of thing. Then talking about the acid suppression modifications, there's some algorithms that we just talked about in the previous slides but it's really on um each each individual lab to come up with a strategy itself. But I would highly recommend using the consensus flow diagram for your strategy model. So the better you know the diary, the benefits from the allied health perspective and and the patient itself is that patient engagement in control. You want to have them feel some empowerment during this test, because they're gonna they're gonna, especially for the first couple, they're gonna feel this little bit of your tent type thing. So you want them to feel empowered during test that they have a sense of control. Make sure it's a partnership, a direct involvement, partnership. This maybe gets therapeutic for them itself. So make sure they feel empowered. And as a time savings you, the better the education you give them, the more concisely annotations, the less time is going to take you to clean up the tests during the editing phase that we'll talk about next week and webinar to for this um focus information gathering, you know, during your conversation with the patient, really key down on the top three symptoms, don't let them, You know, kind of give you 89 10. What are the main three? And if they say reflux, what does that mean with reflexes? That, you know, is that heartburn? Is that chest pain? I'll really kind of dig in the reading their clinical notes and all that type of thing, but do a little bit of a gathering information. So challenges, you know, patient, not adherence. You know, there maybe you had a softie Amanda and now they're having impedance ph test, they're ready to go that type of thing, but make sure that you're feeling like maybe a little bit of a sore throat, this puritan in the throat. So that makes, you know, be really empathetic and compassionate. That limit is not inherent. The embarrassment of having something taped to their face, all they um it's been a little bit better. One of them may be positive things that people have in this, the mask design. It's maybe a little bit less embarrassment, but you know, there's embarrassment to walk around with people looking at, you have something sticking out of your nose taped to your face to understand his embarrassment level. Symptom recall patients may not annotate events at the time across. So we really, really, um, really encourage them to really annotate at the time of their symptoms. That's given the best best opportunity for high quality tests. Um, dismissed any event because patient does not receive is important. So make sure they understand that through this test, you may not think this this is important, but during the data acquisition and editing, that these may become important for giving you the best chance of seeing if you may have heard or anything else. So really say this is important for this test, even though if you don't think it's important, they don't make the instructions too complicated. Very most States. In the United States, either six to eighth grade reading level. That's that's the health literacy guidelines for most states. So make sure they're very simple. Don't make it too complicated. And if you give them too many options, this leads to inconsistency on the diary or the hit the buttons. So limit the options and do not make it too complicated. So in summary, there's many factors that contribute to reflects and you know, it kind of understanding each one of them, the patient's story, there other tests kind of puts all the picture together as your, as the results of the impedance ph test comes back. The penis data is used to measure the presence of the movement of the organic material through the esophagus. Remember as it comes through and bypasses one sensor to another sensor, you'll see the conventional way go down not up and then you'll see when by interest and exits the bullet enters and exits beyond each one of the sensors. Um The PhD and it can be associated with impedance reflex measure, only reflux, not ingested acid materials. We're looking at stuff moving from the stomach into the esophagus and if it's reflux or non reflux and clear instructions for the use of the recorder and diary will increase the quality of the reflex testing. But more important from the allied health perspective time, the less time you're going to have to do with editing the study and making clean ready for the provider to do the interpretation. And the last thing. Remember following a rigorous strategy for setting up and calibrating the Catherine. Getting it ready within a very short period of time prior to having it inserted into the patient is the most optimal way for um collecting higher quality of data. I appreciate everybody spending some time with us this evening. I'm happy to answer any questions anybody may have. Mhm. Why do you recommend not pre soaking in water? Yeah. Yeah a couple of things. It's it's based on the calibration is based on buffer solutions for seven and also the ph of the water could be a little bit often that so it's big. That would be the primary reason. So do it in a buffer solution itself. Um would be the most optimal way to calibrate the plus calibrating the castle. But more important I'm not sure. We we always instruct is that you don't open the catheter package until you're ready to get a calibrated ready to go. I think that's the that's that's probably the primary reason. So the ph sensors don't get dried out and itself. Okay Um Mary striker is saying that she uses this modality Muslim Children under the age of 18 who have undergone general anesthesia. Anesthesia. Should the study be longer than 24 hours due to the relaxation with anesthesia or this provide enough adequate information? That's a good question. That's a good question I would say. That's probably a little bit unknown in the ph reflex in world. Yeah, it's a little bit um it's a little bit inconsistent in the south of geometry. Well some people don't do it after anesthesia. Some people do. Um And that's a really good question. I'm not exactly sure if I know the answer to. I will give you my opinion of the labs that we You know I've ran for the last 21 years. We we often would not do a ph test after anesthesia through endoscopy for a couple of reasons. The physiology is probably a difference in physiology for sure. But more importantly, they're more apt to go home and just kind of be a little bit more lethargic that day. Just because the anesthesia wearing off, they may not eat us regular meal because of potential nausea. Um That that will definitely impact the results of the ph test because it doesn't really represent a normal day because most people are on anesthesia normally. So we would not move forward that more for the latter part of the answer. But I would more than likely there's a physiological impact of doing the test the same day of doing someone have an anesthesia. Mhm. All right. Can multiple probes be calibrated in the same solution throughout the day? As long as no patient fingers haven't dipped in this solution or anything like that. Okay. It can I mean it can you could you could calibrate multiple in the in the tubes itself, it's probably not the optimal way of doing it. I would say do that only a limited, limited time. Like you know if you're I wouldn't make that part of your normal strategy, but it can but it could also lead to some calibration error. Didn't make the catheters itself may be touching that type of thing. So it's a possibility but I wouldn't make that part of your normal process. Okay, how are you cleaning your calibration tubes? Yeah. So they need to be kind of, they need to be cleaned out at the end each day. So you dump everything back out. You can, you know, rent them a little bit of water but then they need to be air dried so you don't want to put them on the counter where you're like the bottom is on the bottom of the counter. You want to kind of put them in something where eric can get in there and kind of dry them out. But just normal water flush. You want to air dry them where air can flow normally through the calibration tubes and not, you know often actually, I've seen people just put the calibration to sort of flat bottom down and no air can get in there. So make sure you just friends a little bit of water and put, make sure they can air dry overnight. Okay, how is it? Um the placement of the probe determine what's the most accurate way to verify the placement of a probe. Yeah. There's been many ways of doing that over time. The most accurate way that the gold standard today is is by a salvageable manama tree and Asafa geometry done with high quality um within one year of the ph test, with no surgical intervention um in between there so a forgot surgical intervention. So they meet all three of those criteria then um the south geometry see measure where the approximately L. S. Borders at on south geometry then um place the catheter appropriately. But if you don't have access to south geometry there are um lower esophageal sphincter locators. Or you can if you're in a pediatric world there's a Cincinnati or struggle chart you can use but at all possible the gold standard of a south geometry prior to doing any ph reflex testing. Are you always performing an esophageal manama tree before every reflux dying? The labs that I helped create. Um That we do require a south geometry. Prior to all ph tests. I have one last question. How young of a patient can have a reflect study? Yeah. So I ran labs everywhere from neonatal up to geriatrics. So every age can have a ph test from neonatal up to geriatrics. But the key is to make sure you choose the appropriate Catheter so that 44, you wouldn't want to put that in neonatal. There's there's specific catheters for specific uh length of patient type of type of uh issue. So make sure you kind of you properly um choose the correct catheter. Um a couple other things you want to do is you want to be especially the neonatal and premiums and that type of thing kids under two. You want to maybe use a struggle chart in the Cincinnati chart and also after you place it you might want to get a chest X ray and make sure you make make sure you have the catheter in the right location. Because those those basically scales are very accurate but they may be a little bit off to some other issues that patient maybe having. So I recommend a chest x ray and making some fine adjustments depending on where the ph sensors at itself. That's a good question. No, really good question. I had a couple more questions to bob. If a symptom occurs over an extended period of time, should the patient be pressing associated button again or only when the symptom begins? That's a great question. So this is part of the education phase. Right? And this is the one there's to come to my mind right away. That is a common occurrence of this one is cough and the others hiccup. So if someone is in a coughing spell, like for example if they're like they're doing that for two straight minutes. It's really annotating when that cough started because there's a conversion windows around when that annotation of that event occurred. And we'll talk more about that next week. But it's not and they're not making an annotation every minute for five minutes. It's really when that cough event started. Hiccupping is the other thing when people are chronically hiccup Urz. Um You want to make sure it's when really the hiccup event occurs. So if not again going back to the S. I. And S. A. P. It really dilutes it because the denominator increases. So um educating the patient especially if that is their main thing, throat clearing is another big one. You have people constantly clearing their throat. Um It's where when that event that series started is when you want them to annotated. But the software is pretty guys, we look next week the software is good at deleting a lot of these. Um So if it does occur, the software is very sophisticated too. Um, you know, delete a lot of these things or measure all of them within one window type of thing. But you know, from the patient's standpoint, if you educate them better, um, it'll be a little bit less for editing for you as you go. You know, get ready for your provider to interpret. Why do you use impedance probes with a ph of gastric channel? Yeah, so you, you give certain metrics, you can measure like ball was clearance, um, uh, that type of measurement. So you know what the ph in the stomach is, then you're going to know what the ph in the esophagus is. So you can see that difference and, and, and acid when you you just clearing is a percentage of bullets clearance percentage. So, um, it really gives you some good separation of just having this, the two in the esophagus body. Um, and it's really the gold standard of mps ph testing is having one in the gastric and then one in the esophagus. Um, when you're assessing them for amateur a reflex. All right, one last question. Jason can you do a ph impedance study with a patient that is getting in g feedings? Um, you can you can often, sometimes the catheter placement is, it becomes a little bit more challenging because the catheters are roughly the same type of materials. So make sure you lubricate your catheter up very liberally the slide adjacent to the two ft. But the other thing is you want to do is especially this happens probably more in the pediatrics and adults, but when you're you want to be, especially if there are continuous feeds or long periods of feel like four hour feeds, you want to make sure you include the feed time in your analysis. Because if not most of your analysis specially it's continuous feed and the software is going to admit feeds you have like one hour of data. So you make sure you include the feed time if someone's that continuous um feeds especially in pediatric world. But you can do a ph test on that and often they're done uh with each other adjacent to each other. Thank you Jason. Well this concludes our webinar significance terminology and proper pub placement. Please join us next week on april 13th from 4 to 5 p.m. Central time for the next webinar in the series where we cover exploring impedance and ph studies. Thank you and good night.