Cricoid Pressure for Acid Reflux
(SE-GERD Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Medical College of Wisconsin
Disqualifiers: Alcohol, Drug abuse, Malignancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?After defining the manometric characteristics of UES incompetence associated with documented pharyngeal reflux, we will determine the reproducibility of manometric criteria for UES incompetence in prevention of pharyngeal reflux. We hypothesize that these criteria are comprised of either a single or constellation of manometric abnormalities. After determining the ability of externally applied cricoid cartilage pressure in preventing pharyngeal reflux, we further hypothesize that this approach will eliminate or reduce esophago-pharyngeal reflux by enhancing the UES pressure barrier. We anticipate there will be a close spatial correlation between the site of applied pressure and area of increased pressure within UES high pressure zone. Lastly, we will determine and characterize the effect of externally applied cricoid cartilage pressure on related functions such as belch and swallow, testing the hypothesis that these functions will not be impaired.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Externally Applied Cricoid Cartilage Pressure for acid reflux?
Research suggests that cricoid pressure can prevent reflux by compressing the esophagus, which may help reduce acid reflux. However, the effectiveness depends on proper application, and there is limited direct evidence for its use specifically for acid reflux.
12345Is cricoid pressure safe for humans?
Cricoid pressure is generally considered safe when applied correctly, with rare complications reported. Proper training and technique are important to ensure safety.
12346How does the treatment of Externally Applied Cricoid Cartilage Pressure for acid reflux differ from other treatments?
This treatment is unique because it involves applying pressure to the cricoid cartilage in the neck to prevent acid reflux by compressing the esophagus, unlike other treatments that typically involve medication or dietary changes. It is a physical technique rather than a drug-based approach.
12367Eligibility Criteria
This trial is for GERD patients with regurgitation and supra-esophageal symptoms, based on American Gastroenterological Association guidelines. It's not for those under 20 or over 85, with a history of alcohol/drug abuse, certain GI/ENT/pulmonary diseases, inability to consent, pregnancy, cancer treatments history, or Lidocaine allergy.Inclusion Criteria
I have GERD with symptoms like heartburn and throat issues.
Patient definition based on position statement and technical reviews of the American Gastroenterological Association and Montreal definition and classification of gastroesophageal and reflux disease (Am J Gastroenterol. 2006;101:1900-1920)
Exclusion Criteria
I am younger than 20 or older than 85.
History or active alcohol or drug abuse
I have had diseases in my upper GI, ears, nose, throat, or lungs that could affect swallowing or my stomach.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Diagnostic Testing
Participants undergo transnasal esophagogastroduodenoscopy (T-EGD) and pH monitoring to verify GERD presence, followed by manometric and impedance testing.
1-2 weeks
1 visit (in-person)
Treatment
Participants receive externally applied cricoid cartilage pressure to prevent pharyngeal reflux and undergo various infusion tests.
2 hours per session, 3 sessions
3 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of UES pressure response and esophageal clearance.
4 weeks
Participant Groups
The study tests if applying pressure to the cricoid cartilage can prevent acid reflux into the throat by strengthening the upper esophageal sphincter (UES). The effect on swallowing and belching will also be observed to ensure these functions aren't negatively impacted.
1Treatment groups
Experimental Treatment
Group I: Patients with supra-esophageal gastroesophageal reflux diseaseExperimental Treatment1 Intervention
GERD patients with complaints of regurgitation and supra-esophageal symptoms
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Reza ShakerMilwaukee, WI
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Who Is Running the Clinical Trial?
Medical College of WisconsinLead Sponsor
References
Comparative effect of the sites of anterior cervical pressure on the geometry of the upper esophageal sphincter high-pressure zone. [2018]External cricoid pressure is increasingly used to augment the upper esophageal sphincter (UES). Our objective was to determine the effect of 1) pressures applied to cricoid, supracricoid, and subcricoid regions on the length and amplitude of the UES high-pressure zone (UESHPZ), and 2) the external cricoid pressure on lower esophageal sphincter (LES) tone.
[Cricoid pressure--safety necessity or unnecessary risk?]. [2006]Cricoid pressure is a simple and effective measure to prevent regurgitation of gastric juice and content. This procedure, which prevents a possible reflux by compression of the oesophagus between the cricoid cartilage and the cervical vertebral bodies, is generally acknowledged in clinical practice, although there is lack of scientific evidence regarding its effect on the outcome of patients at risk of aspiration. However, there is only a rare incidence of complications as long as cricoid pressure is used with exact indication, considering the contraindications and correct performance. Especially important are the optimal force applied on the cricoid and the duration of application. However, there is a lot of evidence in the literature that the knowledge of anaesthetists about the method and technique of cricoid pressure is rather unsatisfactory. Thus, the starting point for improving the efficiency and safety of cricoid pressure seems to be better teaching and training.
[Training in application of cricoid pressure]. [2006]Applying cricoid pressure is a simple and effective means of preventing aspiration of gastric juice and content. This procedure prevents a possible reflux by compressing the esophagus between the cricoid cartilage and the cervical vertebral bodies. Recent studies recommend a pressure of 30-40 N. The present study was undertaken to determine whether with education and practice, anesthesia assisitants could be taught a recommended cricoid pressure and retain this skill.
Endoscopic balloon catheter dilatation via retrograde or static technique is safe and effective for cricopharyngeal dysfunction. [2022]To evaluate the safety and efficacy of upper esophageal sphincter (UES) dilatation for cricopharyngeal (CP) dysfunction. To determine if: (1) indication for dilatation; or (2) technique of dilatation correlated with symptom improvement.
Cricoid Pressure Controversies: Narrative Review. [2022]Since cricoid pressure was introduced into clinical practice, controversial issues have arisen, including necessity, effectiveness in preventing aspiration, quantifying the cricoid force, and its reliability in certain clinical entities and in the presence of gastric tubes. Cricoid pressure-associated complications have also been alleged, such as airway obstruction leading to interference with manual ventilation, laryngeal visualization, tracheal intubation, placement of supraglottic devices, and relaxation of the lower esophageal sphincter. This review synthesizes available information to identify, address, and attempt to resolve the controversies related to cricoid pressure. The effective use of cricoid pressure requires that the applied force is sufficient to occlude the esophageal entrance while avoiding airway-related complications. Most of these complications are caused by excessive or inadequate force or by misapplication of cricoid pressure. Because a simple-to-use and reliable cricoid pressure device is not commercially available, regular training of personnel, using technology-enhanced cricoid pressure simulation, is required. The current status of cricoid pressure and objectives for future cricoid pressure-related research are also discussed.
Cricoid cartilage pressure decreases lower esophageal sphincter tone. [2019]Cricoid cartilage pressure induced to prevent pulmonary aspiration from regurgitation of gastric contents has been recommended, and its efficacy requires a force greater than 40 Newtons. For regurgitation to occur, both an increase in gastric pressure and relaxation of the lower esophageal sphincter (LES) are necessary. However, the effect of cricoid cartilage pressure on the LES is unknown. This study evaluated the effects of cricoid cartilage pressure on LES in human volunteers.
Effect of cricoid pressure on gastro-oesophageal reflux in awake subjects. [2019]This study aimed to evaluate whether cricoid pressure is associated with a high risk of gastro-oesophageal reflux. Fifteen awake, fasted volunteers were studied. A cricoid pressure of 44 N was applied for 60 s by resting a padded yoke over the cricoid cartilage. Using continuous oesophageal pH monitoring, no volunteer had gastro-oesophageal reflux during cricoid pressure, although one subject had a reflux spike soon after relieving cricoid pressure. We conclude with 95% confidence that the incidence of gastro-oesophageal reflux during cricoid pressure is not more than 20%.