This prospective, single-centre, randomized controlled trial evaluates whether high-flow nasal oxygen (HFNO) reduces hypoxaemia compared with conventional low-flow oxygen therapy (COT) during endoscopic retrograde cholangiopancreatography (ERCP) performed under sedation in geriatric and adult patients.
One hundred ASA I-III patients undergoing ERCP were stratified by age (\<65 and ≥65 years) and randomized to receive HFNO or COT. The primary outcome is the incidence of hypoxaemia (SpO₂ ≤90%). Secondary outcomes include hypotension, haemodynamic changes, sedative consumption, and recovery time.
Who can participate
Age range
18 Years – 99 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:
* Age ≥18 years
* Patients scheduled for elective endoscopic retrograde cholangiopancreatography (ERCP)
* Planned sedation with monitored anesthesia care
* ASA physical status I-III
* Ability to provide written informed consent
* Adult group: 18-64 years
* Geriatric group: ≥65 years
Exclusion Criteria:
* Severe cardiac, pulmonary, renal, neurological, or hepatic disease
* Baseline hypotension (systolic arterial pressure \<90 mmHg) or uncontrolled hypertension (systolic arterial pressure \>170 mmHg, diastolic pressure \>100 mmHg)
* Pre-existing hypoxaemia (SpO₂ \<90%)
* Known hypersensitivity to study medications or a history of sedation-related adverse events
* Use of sedative medication within 24 hours prior to the procedure
* Refusal to participate
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
Incidence of hypoxemia during ERCP
Timeframe: During the ERCP procedure
Trial details
NCT IDNCT07493811
SponsorProf. Dr. Cemil Tascıoglu Education and Research Hospital Organization