Understanding the effects of endoscopic myotomy on breathing and blood flow
Respiratory and Hemodynamic Implications of Endoscopic Myotomy of the Esophagus and Stomach (POEM/GPOEM)
This study is testing how endoscopic treatments for esophageal issues affect breathing and blood flow in patients during anesthesia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire Vaudois Academic / other |
| Locations | 1 site (Lausanne, Vaud) |
| Trial ID | NCT05602272 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the respiratory and hemodynamic effects during general anesthesia in patients with esophageal achalasia or gastroparesis who undergo endoscopic treatments like peroral endoscopic myotomy (POEM) or gastric peroral endoscopic myotomy (GPOEM). The study will assess the predictability of adverse events and the relationship between intra-abdominal pressure and changes in respiratory and hemodynamic parameters. Participants will receive standard care during the procedure, and the study will focus on collecting data related to complications associated with anesthesia. The findings could enhance understanding of anesthetic management in these procedures.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for POEM or GPOEM procedures and classified as ASA risk 1 to 3.
Not a fit: Patients who are unable to follow study procedures due to language barriers, psychological disorders, or dementia may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and effectiveness of anesthetic management during endoscopic treatments for esophageal and gastric motility disorders.
How similar studies have performed: While the approach of studying anesthetic management in these specific procedures is relatively novel, similar studies have shown the importance of understanding complications in endoscopic treatments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Completed and signed consent form (consent form attached) * Age ≥ 18 years old * Anesthetic risk classification according to ASA, from 1 to 3 * Patients summoned for POEM or GPOEM type endoscopy treatment Exclusion Criteria: - Inability to follow study procedures, eg. due to language problems, psychological disorders, dementia, etc. of the participant
Where this trial is running
Lausanne, Vaud
- Chuv — Lausanne, Vaud, Switzerland (Recruiting)
Study contacts
- Principal investigator: Madeleine Chollet-Rivier — University of Lausanne Hospitals
- Study coordinator: Aldo Cavuoto
- Email: aldo.cavuoto@chuv.ch
- Phone: 795565766
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.