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

100 Participants Needed

Trial Summary

What is the purpose of this trial?

1. An intact pharyngoesophageal reflex is essential to protect the upper airway from aspiration of either mouth contents or regurgitated gastric refluxate. This reflex is essential at protecting the airway in all patients. 2. In patients, while under medication to tolerate endotracheal intubation, it is postulated that an identifiable upper esophageal sphincter and esophageal peristalsis are not present. 3. With the cessation of anesthetics, accompanied by the reversal of nerve block, normal pharyngoesophageal peristaltic activity correlates with awakening the patient from anesthesia. This would be identified by the performance of esophageal manometry. 4. A return of normal verbally stimulated pharyngoesophageal swallowing sequence accurately identifies a safe time to remove endotracheal tubes and/or reverse anesthesia. This verbally stimulated swallowing sequence correlated precisely with the return of objective pharyngoesophageal function.

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 data supports the effectiveness of the treatment Esophageal Manometry for gastrointestinal motility?

Esophageal manometry is effective in diagnosing and understanding esophageal motility disorders, such as achalasia and spastic disorders, by measuring pressure changes in the esophagus. It helps in planning treatments and evaluating their success, especially before and after surgical procedures. ^{1 2 3 4 5}

Is esophageal manometry safe for humans?

The research articles provided do not contain specific safety data for esophageal manometry. However, they discuss general methods for evaluating the safety of medical treatments, which include monitoring adverse events and using databases to track safety issues. ^{6 7 8 9 10}

How is esophageal manometry different from other treatments for gastrointestinal motility issues?

Esophageal manometry is unique because it measures the pressure inside the esophagus to assess how well it moves food from the throat to the stomach, which helps diagnose motility disorders. Unlike other treatments, it provides detailed pressure profiles and is often used after other tests like endoscopy to confirm a diagnosis. ^{2 3 11 12 13}

Research Team

Stanley J Rogers, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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 between 18 and 70 years old with a low to moderate risk during surgery.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

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

Esophageal Motility Disorders: Current Approach to Diagnostics and Therapeutics. [2023]

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

The place of esophageal manometry in the diagnosis of dysphagia. [2019]

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

Neuromotor disorders of the esophagus. [2004]

4. England pubmed.ncbi.nlm.nih.gov

High resolution manometry and multichannel intraluminal impedance oesophageal manometry in clinical practice. [2020]

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

Utility and standards in esophageal manometry. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The SMART Safety: An empirical dataset for evidence synthesis of adverse events. [2023]

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

Accuracy of an automated knowledge base for identifying drug adverse reactions. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Drug safety assessment in clinical trials: methodological challenges and opportunities. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Monitoring product safety in the postmarketing environment. [2021]

10. New Zealand pubmed.ncbi.nlm.nih.gov

EudraVigilance Medicines Safety Database: Publicly Accessible Data for Research and Public Health Protection. [2021]

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

New esophageal function testing (impedance, Bravo pH monitoring, and high-resolution manometry): clinical relevance. [2021]

12. Germany pubmed.ncbi.nlm.nih.gov

[Performance and interpretation of esophageal manometry: recommendations of the German Societies for Neurogastroenterology and Motility (DGNM), for Digestive and Metabolic Diseases (DGVS) and for General and Visceral Surgery (DGAV)]. [2009]

13. Brazil pubmed.ncbi.nlm.nih.gov

NORMATIVE VALUES FOR A NEW WATER-PERFUSED HIGH RESOLUTION MANOMETRY SYSTEM. [2019]