High-flow Nasal Oxygen Therapy for Advanced Endoscopy in High-risk Patients. (NCT06610461) | Clinical Trial Compass
CompletedNot Applicable
High-flow Nasal Oxygen Therapy for Advanced Endoscopy in High-risk Patients.
United States180 participantsStarted 2024-09-25
Plain-language 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, sedation during endoscopy carries a serious risk of blood oxygen desaturation.
This study aims to investigate the hypothesis if the application of high-flow nasal oxygen (HFNO) during high-risk gastroscopy reduces the risk of blood oxygen levels to drop below a defined threshold. Enrolled patients will be randomly assigned to either the control group, receiving standard care during endoscopy, or the intervention group, receiving HFNO therapy during the procedure. Throughout the intervention, vital parameters will be recorded. Care providers will be asked to answer a questionnaire that specifically evaluates the effect of HFNO on patient safety and the procedure.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Additional actions had to be taken to ensure sufficient SpO2 oxygenation.
Timeframe: The primary outcome will be assessed in the time between start of induction of anesthesia and awakening until discharge from the procedural room, which is typically between 30 and 120 minutes