Esophageal Manometry for Gastrointestinal Motility

Overseen By Alex Rodas, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Must not be taking: Anticoagulants

Disqualifiers: Pregnancy, Coagulopathy, Arrhythmia, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how esophageal manometry (a procedure that measures esophagus function) can help determine the best time to safely remove breathing tubes after surgery. Researchers aim to see if normal swallowing and esophagus movement return when anesthesia wears off. The study seeks participants already scheduled for breathing tube removal who can give consent in English or Spanish. As an unphased trial, it offers participants the opportunity to contribute to important research that could improve post-surgical care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using anticoagulants like heparin or Plavix. It's best to discuss your specific medications with the trial team.

What prior data suggests that this manometry device is safe for gastrointestinal motility?

Studies have shown that esophageal manometry is generally safe and well-tolerated. This test evaluates how well the esophagus, the tube connecting the throat to the stomach, moves and handles pressure. Research indicates that complications are rare, and most people do not experience major issues. Only about 1 in 100 people find the procedure difficult to tolerate, with children more likely to experience this. Overall, evidence suggests that esophageal manometry is a safe method to assess esophageal function. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because esophageal manometry offers a unique way to understand gastrointestinal motility issues. Unlike standard treatments that primarily focus on symptom management with medications or dietary changes, esophageal manometry provides detailed insights into how well the muscles of the esophagus are working. By using a manometry device to measure pressure within the esophagus, this method can help pinpoint specific motility disorders, which could lead to more targeted and effective treatments. The anticipation is that this technique will not only enhance diagnosis but also refine treatment strategies, improving outcomes for patients with esophageal motility disorders.

What evidence suggests that esophageal manometry is effective for assessing gastrointestinal motility?

Research has shown that esophageal manometry, which participants in this trial will undergo, is a useful test for understanding esophageal movement. It effectively identifies problems like achalasia, where the esophagus struggles to move food to the stomach. Studies have found this test most helpful for individuals with difficulty swallowing. Esophageal manometry can pinpoint issues with the upper esophageal sphincter, crucial for safe swallowing. Although less helpful for other symptoms, it accurately assesses the function of the esophagus and related muscles. ^{6 7 8 9 10}

Who Is on the Research Team?

Stanley J Rogers, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for adults aged 18-70, who can consent in English or Spanish and are scheduled for endotracheal tube removal. It's not for pregnant or breastfeeding individuals, those with blood disorders, severe kidney issues, nasal blockages, certain heart conditions, or a history of esophageal problems.

Inclusion Criteria

I am scheduled to have my breathing tube removed.

I can give my consent in English or Spanish.

Exclusion Criteria

Refusal to give informed consent

Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data

Patients not meeting entry criteria above

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Manometry Procedure

Routine high-resolution solid state manometry is performed to study esophageal function during recovery from anesthesia

10-15 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the manometry procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Esophageal Manometry

Trial Overview The study tests if high-resolution solid-state manometry can detect the return of normal swallowing reflexes after anesthesia. This could help determine when it's safe to remove breathing tubes post-surgery.

How Is the Trial Designed?

Group I: Manometry Device Experimental Treatment 1 Intervention

At 10 minutes prior to anticipated removal of the endotracheal tube, pass the routine manometry catheter per naris to 30 cms.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Published Research Related to This Trial

The SMART Safety dataset is the largest collection of empirical data on adverse events in healthcare, comprising 151 systematic reviews and 629 meta-analyses, which enhances the understanding of safety outcomes in randomized controlled trials.

This dataset, which includes over 2,300 trials and 362 harm outcomes, has been rigorously validated to ensure high data quality, providing a valuable resource for addressing rare adverse events and biases in evidence synthesis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SMART Safety: An empirical dataset for evidence synthesis of adverse events. Fan, S., Yu, T., Yang, X., et al.[2023]

Randomized controlled trials (RCTs) are essential for determining drug efficacy, but they often lack the size and duration needed to identify rare but serious side effects, especially in high-risk populations.

To improve drug safety evaluations, it's crucial to analyze data from various sources, use robust statistical methods in meta-analyses, and foster collaborations between regulatory bodies and academia for independent assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug safety assessment in clinical trials: methodological challenges and opportunities. Singh, S., Loke, YK.[2022]

The study developed an automated method to aggregate various sources of drug safety information, achieving high predictive accuracy (≥0.92) in classifying drug-adverse event relationships, which can significantly streamline the process of identifying drugs associated with adverse reactions.

This approach offers a scalable alternative to the traditional manual curation methods, potentially saving time and resources in drug safety research by efficiently creating reference sets of drugs that do or do not cause adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accuracy of an automated knowledge base for identifying drug adverse reactions. Voss, EA., Boyce, RD., Ryan, PB., et al.[2019]

EudraVigilance, the European pharmacovigilance database, has been crucial for monitoring the safety of medicines since its launch in 2001, with 50% of scientific publications using its data to describe safety issues.

Recent enhancements to EudraVigilance, including broader access to data and improved functionalities, aim to facilitate better safety monitoring and support health research, ultimately promoting the safe and effective use of medicines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. Postigo, R., Brosch, S., Slattery, J., et al.[2021]

The safety profile of medications can change after they are approved for public use, as new safety issues may arise that were not identified during clinical trials.

Regulatory agencies, like the FDA, actively monitor medication safety through various methods, including analyzing adverse experience reports and using large electronic databases to detect potential safety signals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. Sharrar, RG., Dieck, GS.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9405585/

Esophageal Motility Disorders: Current Approach to ... HRM has improved the sensitivity for detecting achalasia and has also enhanced our understanding of spastic and hypomotility disorders of the esophageal body.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8521467/

Diagnostic Yield of High-resolution Esophageal ... Esophageal manometry provided the highest yield in dysphagia; it was not a strongly beneficial test in patients presenting with non-dysphagia.

3. mayoclinicproceedings.org mayoclinicproceedings.org/article/S0025-6196(24)00621-9/fulltext

Esophageal Motility Disorders: A Concise Review on ... This clinical review aims to provide a concise yet comprehensive summary on classification, diagnosis, and management of EMDs.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508522001974

Esophageal Motility Disorders: Current Approach to ... Manometric diagnosis of IEM has evolved over time and now require more than 70% ineffective swallows (DCI ≥100 mm Hg•s•cm and <450 mm Hg•s•cm) or at least 50% ...

5. nature.com nature.com/gimo/contents/pt1/full/gimo30.html

Esophageal manometry : GI Motility online Pharyngeal motility is most effectively assessed radiologically, and manometry is most useful to clarify upper esophageal sphincter function.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK559237/

Esophageal Manometry - StatPearls - NCBI Bookshelf - NIH Esophageal manometry is the evaluation of the movement and pressure of the esophagus. Conventional esophageal manometry uses probes every 5 cm in the esophagus.

7. gastrojournal.org gastrojournal.org/article/S0016-5085(22)00197-4/fulltext

Esophageal Motility Disorders: Current Approach to ... In this review, we discuss the current approach to diagnosis and therapeutics of various esophageal motility disorders.

8. aafp.org aafp.org/pubs/afp/issues/2020/0901/p291.html

Esophageal Motility Disorders Patients with functional esophageal disorders have excellent long-term outcomes: approximately 50% have complete resolution of symptoms, and ...

9. journals.lww.com journals.lww.com/ctg/fulltext/2023/05000/safety_and_tolerability_of_high_resolution.4.aspx

Safety and Tolerability of High-Resolution Esophageal... HRM is safe and well-tolerated with approximately 1 in every 100 patients being unable to tolerate HRM. Intolerance was more commonly seen in children and ...

10. mayoclinic.org mayoclinic.org/tests-procedures/esophageal-manometry/about/pac-20394000

Esophageal manometry Esophageal manometry is generally safe, and complications are rare. ... Oropharyngeal & esophageal motility disorders. In: Greenberger's ...