Using high-flow nasal oxygen therapy during high-risk endoscopy procedures
High-flow Nasal Oxygen Versus Face Mask or Nasal Cannula for Advanced Endoscopy in High-risk Patients
This study tests if using high-flow nasal oxygen during risky upper GI endoscopy can help keep patients' blood oxygen levels stable compared to regular oxygen methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06610461 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of high-flow nasal oxygen (HFNO) therapy in preventing hypoxemia during high-risk upper gastrointestinal endoscopy procedures. Patients will be randomly assigned to either receive standard care or HFNO therapy during anesthesia. The study will monitor vital parameters and gather feedback from care providers regarding patient safety and procedural outcomes. The goal is to determine if HFNO can significantly reduce the risk of blood oxygen desaturation compared to standard oxygen delivery methods.
Who should consider this trial
Good fit: Ideal candidates include patients undergoing upper endoscopy with risk factors such as obesity, sleep apnea, or low baseline oxygen saturation.
Not a fit: Patients who are pregnant, have a current COVID-19 infection, or require general anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance patient safety and comfort during high-risk endoscopic procedures by reducing the incidence of hypoxemia.
How similar studies have performed: Other studies have shown promising results with high-flow nasal oxygen therapy in similar settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Upper endoscopy (EGD, ERCP, EUC etc.) w/wo colonoscopy expected duration \> 15 min under MAC * one or more of the following: * Diagnosis of sleep apnea * BMI ≥ 30 kg/m2 * Baseline SpO2 \< 96% or Requirement for long-term oxygen therapy * BOSTN score ≥ 2 * BMI ≥ 30 kg/m2 * Observed apnea * Observed loud Snoring * Daytime Tiredness * Neck circumference ≥ 16.5 inches in female, ≥ 17.5 inches in male Exclusion Criteria: * Known Pregnancy * Known Current infection with COVID-19 * Planned general anesthesia
Where this trial is running
Boston, Massachusetts
- Anesthesia, Critical Care and Pain Medicine Department at Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Maximilian S. Schaefer, MD, PhD
- Email: msschaef@bidmc.harvard.edu
- Phone: 617-667-3112
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.