Cricoid Pressure for Acid Reflux

(SE-GERD Trial)

Overseen By Mark Kern

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Medical College of Wisconsin

Disqualifiers: Alcohol, Drug abuse, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 2 hours per session, 3 sessions

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether pressing on the cricoid cartilage (a part of the throat) can prevent acid from rising into the throat in people with GERD, a condition causing acid reflux. Researchers aim to determine if this pressure, known as Externally Applied Cricoid Cartilage Pressure Therapy, can stop or reduce symptoms like regurgitation and throat issues without affecting swallowing or belching. It targets individuals who frequently experience these reflux symptoms. Participants should have GERD with symptoms such as regurgitation and throat discomfort. As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new ways to manage GERD symptoms.

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 prior data suggests that this technique is safe for preventing pharyngeal reflux?

Research has shown that pressing on the cricoid cartilage (the firm area on the neck above the voice box) can increase pressure in the upper esophageal sphincter (UES). This action helps prevent stomach acid from moving up into the throat. One study observed this pressure increase, which is promising for managing acid reflux.

Reports indicate that patients generally tolerate this treatment well. These studies have not reported any major side effects. The treatment is non-invasive, meaning it doesn't involve surgery or entering the body, which usually results in fewer side effects. Prospective trial participants should find these findings encouraging, as they suggest the treatment is safe to use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about applying cricoid cartilage pressure for acid reflux because it offers a non-invasive approach to managing symptoms. Unlike standard treatments that often involve medications like proton pump inhibitors or H2 blockers to reduce stomach acid, this method physically prevents acid from regurgitating by applying pressure to the cricoid cartilage. This technique could provide immediate relief without the side effects associated with long-term medication use. Additionally, it may be particularly beneficial for patients experiencing supra-esophageal symptoms, which are not always adequately addressed by current medications.

What evidence suggests that externally applied cricoid cartilage pressure is effective for acid reflux?

Research shows that pressing on the neck just below the Adam's apple, known as cricoid pressure, can help stop acid reflux from reaching the throat. This trial will study the effects of Externally Applied Cricoid Cartilage Pressure on patients with supra-esophageal gastroesophageal reflux disease. Studies have found that this pressure strengthens the upper esophageal sphincter (UES), which helps keep stomach acid down. By strengthening the UES, this method seems to prevent acid from moving up, reducing symptoms like regurgitation. Additionally, evidence suggests that this technique is safe and does not affect swallowing or belching. Overall, early findings indicate that this simple, non-invasive approach may effectively reduce throat reflux. ^{1 5 6 7 8}

Who Is on the Research Team?

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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

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)

I have GERD with symptoms like heartburn and throat issues.

Exclusion Criteria

History or active alcohol or drug abuse

Pregnant women (see justification in the Women and Minority Inclusion in Clinical Research section)

History of allergy to Lidocaine for nasal topical anesthesia

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Externally Applied Cricoid Cartilage Pressure

Trial Overview 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.

How Is the Trial Designed?

Group I: Patients with supra-esophageal gastroesophageal reflux disease Experimental Treatment 1 Intervention

GERD patients with complaints of regurgitation and supra-esophageal symptoms

Who Is Running the Clinical Trial?

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

Published Research Related to This Trial

Cricoid pressure is an effective technique to prevent regurgitation of gastric contents during anesthesia by compressing the esophagus, although scientific evidence on its impact on patient outcomes is limited.

While complications from cricoid pressure are rare when applied correctly, there is a significant gap in anesthetists' knowledge about the proper technique, highlighting the need for improved training and education to enhance its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cricoid pressure--safety necessity or unnecessary risk?]. Janda, M., Vagts, DA., Nöldge-Schomburg, GF.[2006]

In a study involving 15 awake, fasted volunteers, applying cricoid pressure did not result in gastro-oesophageal reflux, as confirmed by continuous oesophageal pH monitoring.

The study concluded with 95% confidence that the incidence of gastro-oesophageal reflux during cricoid pressure is not more than 20%, suggesting that cricoid pressure may be a safe practice in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of cricoid pressure on gastro-oesophageal reflux in awake subjects. Skinner, HJ., Bedforth, NM., Girling, KJ., et al.[2019]

Applying cricoid cartilage pressure significantly decreases lower esophageal sphincter (LES) pressure, dropping from 24 mmHg to 15 mmHg at 20 Newtons and to 12 mmHg at 40 Newtons, which could increase the risk of regurgitation.

This study, involving 8 healthy volunteers, suggests that the recommended cricoid pressure may not effectively prevent pulmonary aspiration due to its impact on LES function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cricoid cartilage pressure decreases lower esophageal sphincter tone. Tournadre, JP., Chassard, D., Berrada, KR., et al.[2019]

In a study involving 34 anesthesia assistants, only 4 doctors and 5 nurses effectively applied the recommended cricoid pressure before training, highlighting a significant skill gap.

After training, while 13 doctors and 12 nurses could apply the pressure correctly, they were unable to retain this skill after one month, indicating the need for ongoing training to maintain proficiency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Training in application of cricoid pressure]. Shimabukuro, A., Kawatani, M., Nagao, N., et al.[2006]

Upper esophageal sphincter (UES) dilatation is a safe and effective treatment for dysphagia caused by cricopharyngeal dysfunction, with 79% of patients reporting symptom improvement after the procedure.

The study found no significant difference in symptom improvement between static and retrograde dilatation techniques, indicating that both methods are equally effective for this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic balloon catheter dilatation via retrograde or static technique is safe and effective for cricopharyngeal dysfunction. Chandrasekhara, V., Koh, J., Lattimer, L., et al.[2022]

Cricoid pressure is intended to prevent aspiration during intubation, but its effectiveness and necessity are debated, with complications arising from improper application or force, such as airway obstruction and difficulties in intubation.

Regular training and the use of simulation technology are essential for healthcare personnel to apply cricoid pressure correctly, as there is currently no reliable commercial device available for consistent application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cricoid Pressure Controversies: Narrative Review. Salem, MR., Khorasani, A., Zeidan, A., et al.[2022]

Applying external cricoid pressure significantly increases the length of the upper esophageal sphincter high-pressure zone (UESHPZ) across various pressure levels, with the most effective site being at the cricoid and supracricoid regions.

External cricoid pressure does not affect the tone of the lower esophageal sphincter (LES), indicating that while it can enhance UES function, it does not influence LES pressure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of the sites of anterior cervical pressure on the geometry of the upper esophageal sphincter high-pressure zone. Mei, L., Jiao, H., Sharma, T., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5654682/

Comparative Effect of Sites of Anterior Cervical Pressure ... In all participants, all the applied external cricoid pressures were well tolerated. There was no untoward outcomes or complaints. Length of UESHPZ. In healthy ...

2. withpower.com withpower.com/trial/phase-esophagitis-peptic-2014-1b6de

Cricoid Pressure for Acid Reflux (SE-GERD Trial) Applying cricoid cartilage pressure significantly decreases lower esophageal sphincter (LES) pressure, dropping from 24 mmHg to 15 mmHg at 20 Newtons and to 12 ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4332774/

Prevention of Esophagopharyngeal Reflux Application of 20 to 30 mm Hg cricoid pressure significantly increases the UES intraluminal pressure and prevents pharyngeal reflux induced by esophageal slow ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05697393

External UES Band (Shaker Pressure Band) and GERD There is evidence that external pressure to the upper esophageal sphincter can decrease the amount of reflux into the pharynx and possibly decrease these ...

5. researchgate.net researchgate.net/publication/261958389_Prevention_of_Esophagopharyngeal_Reflux_by_Augmenting_the_Upper_Esophageal_Sphincter_Pressure_Barrier

Prevention of Esophagopharyngeal Reflux by Augmenting ... The innovative UESAD, a non-invasive and non-pharmacological intervention applying external cricoid pressure to boost intraluminal UES pressure ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8286644/

Upper Esophageal Sphincter Compression Device as an ... This study aimed to assess device efficacy as an adjunct to proton pump inhibitor (PPI) therapy in patients with laryngopharyngeal reflux (LPR).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4967170/

A human model of restricted upper esophageal sphincter ... A previous study has shown that applying cricoid pressure can enhance UES resting pressure to prevent supraesophageal reflux (23). The present study shows that ...

8. accessdata.fda.gov accessdata.fda.gov/SCRIPTs/cdrh/cfdocs/cfpcd/classification.cfm?ID=1769

Product Classification - FDA The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach ...