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

90 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 6}

How 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. ^{1 2 3 6 7}

Research Team

Reza Shaker, MD

Principal Investigator

Medical College of Wisconsin

Eligibility 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.

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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 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 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]

References

1. United States 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. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Cricoid pressure--safety necessity or unnecessary risk?]. [2006]

3. Japan pubmed.ncbi.nlm.nih.gov

[Training in application of cricoid pressure]. [2006]

4. United States pubmed.ncbi.nlm.nih.gov

Endoscopic balloon catheter dilatation via retrograde or static technique is safe and effective for cricopharyngeal dysfunction. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Cricoid Pressure Controversies: Narrative Review. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Cricoid cartilage pressure decreases lower esophageal sphincter tone. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Effect of cricoid pressure on gastro-oesophageal reflux in awake subjects. [2019]