High-flow Nasal Oxygen Therapy for Advanced Endoscopy in High-risk Patients.
Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Sep 20, 2024
Trial Information
Current as of July 01, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying whether using high-flow nasal oxygen (HFNO) during certain types of endoscopy can help prevent low blood oxygen levels in patients who are at higher risk. Endoscopy is a procedure that allows doctors to look inside the stomach and intestines, but it can cause some patients to have trouble breathing while they are sedated. The researchers want to see if HFNO, which provides extra oxygen through a nasal tube, can make these procedures safer.
To participate in the trial, patients typically need to be between 65 and 74 years old and scheduled for a specific type of endoscopy that is expected to last more than 15 minutes while being under sedation. They should have certain health conditions, like sleep apnea or a higher body mass index (BMI), which can increase their risk during the procedure. Participants will be randomly assigned to either receive standard care or the HFNO treatment during their endoscopy. Throughout the procedure, the medical team will monitor their vital signs and gather feedback on how the HFNO affects patient safety and comfort. This study is currently looking for volunteers, and it's important to note that pregnant women and those with ongoing COVID-19 infections cannot participate.
Gender
ALL
Eligibility 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
About Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center (BIDMC) is a leading academic medical center located in Boston, Massachusetts, affiliated with Harvard Medical School. Renowned for its commitment to cutting-edge research and innovation in healthcare, BIDMC fosters a collaborative environment that integrates patient care, education, and scientific investigation. The center actively sponsors clinical trials across a variety of disciplines, aiming to advance medical knowledge and improve patient outcomes. With a focus on translational medicine, BIDMC's research initiatives engage multidisciplinary teams to address complex health challenges and translate findings into effective therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Boston, Massachusetts, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported