Status:
COMPLETED
High-flow Nasal Oxygen Therapy for Advanced Endoscopy in High-risk Patients.
Lead Sponsor:
Beth Israel Deaconess Medical Center
Conditions:
Hypoxemia During Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Anesthesia is crucial during upper GI endoscopy in order to improve the procedural conditions for the interventionist, increase the quality of examination and alleviate patient discomfort. However, se...
Detailed Description
This non-blinded, randomized controlled trial compares two study groups, the interventional and control group, to investigate whether HFNO-treatment reduces the risk of hypoxemia during peri-intervent...
Eligibility Criteria
Inclusion
- 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
- Known Pregnancy
- Known Current infection with COVID-19
- Planned general anesthesia
Key Trial Info
Start Date :
September 25 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 12 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06610461
Start Date
September 25 2024
End Date
September 12 2025
Last Update
October 7 2025
Active Locations (1)
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1
Anesthesia, Critical Care and Pain Medicine Department at Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215