Impact of Nasal Mask Versus Nasal Cannula Oxygenation on Hypoxemia in Gastrointestinal Endoscopy:… (NCT07500779) | Clinical Trial Compass
CompletedNot Applicable
Impact of Nasal Mask Versus Nasal Cannula Oxygenation on Hypoxemia in Gastrointestinal Endoscopy: A Brain Function Monitoring (SedLine)-Guided Randomized Controlled Trial (NAMSHIC)
This randomized controlled trial compared the efficacy of a nasal mask versus a standard nasal cannula for oxygen delivery during gastrointestinal endoscopic procedures performed under target controlled propofol infusion anesthesia with SedLine brain function monitoring. Hypoxemia during procedural sedation is a common and clinically relevant event, especially during upper endoscopy and combined procedures. The study aimed to determine whether nasal mask oxygenation reduces hypoxemia compared with nasal cannula oxygenation when sedation depth is guided with electroencephalography based monitoring.
Eligible adult patients undergoing gastrointestinal endoscopic procedures were randomly assigned to receive oxygen either via a nasal mask or via a nasal cannula. Oxygen was administered at a fixed flow rate according to the study protocol. Sedation was provided with target controlled propofol infusion, and SedLine monitoring was used to guide sedation depth throughout the procedure.
The primary outcome was the occurrence of hypoxemia, defined as peripheral oxygen saturation at or below 90 percent. Secondary outcomes included severe hypoxemia, duration of hypoxemia, lowest peripheral oxygen saturation value, need for airway interventions, other adverse events during the procedure, procedure time, recovery time, and operator satisfaction ratings. The study has been completed.
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:
* Adults aged 18 years or older.
Scheduled for gastrointestinal endoscopic procedures (upper endoscopy and or colonoscopy) under propofol sedation using target controlled infusion with SedLine monitoring.
American Society of Anesthesiologists (ASA) physical status I to III.
Provided written informed consent.
Exclusion Criteria:
* Refusal or inability to provide informed consent.
Known allergy or contraindication to propofol or study related materials.
Severe cardiorespiratory instability or conditions judged by the investigator to increase procedural risk.
Pregnancy.
Requirement for tracheal intubation or general anesthesia at the outset of the procedure.
Significant anatomic or clinical factors precluding use of the assigned oxygen delivery device.
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
Hypoxemia
Timeframe: During the endoscopic procedure and immediate recovery period (from start of sedation to discharge from the recovery area).
Trial details
NCT IDNCT07500779
SponsorSultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey