The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastr… (NCT04123821) | Clinical Trial Compass
CompletedNot Applicable
The Routine Use of Nasopharyngeal Airway in the Setting of Monitored Anesthesia Care During Gastrointestinal Endoscopy
Lebanon334 participantsStarted 2019-11-11
Plain-language summary
The goal of this prospective, multi-center, single-blinded randomized controlled trial is to assess the efficacy of NPA in reducing respiratory events in patients being admitted for GI endoscopy (colonoscopy, gastroscopy, endoscopic ultrasound) under deep sedation. The main question it aims to answer are: • \[Is the NPA used on patients undergoing gastrointestinal endoscopy efficient in reducing respiratory events?\] Participants will be randomly allocated into one of the two groups: NPA with 5L/min oxygen through nasal cannula (group A) or 5 L/min oxygen through nasal cannula alone (group B). Researchers will compare NPA group to nasal cannula group to see if the routine placement of an NPA can reduce the frequency of airway obstruction, hypoxemic events and airway maneuvers (chin lift, oral airway insertion, and mask-bag ventilation) during endoscopic sedation.
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:
* Patients undergoing GI endoscopy under MAC using TCI of Propofol
* Patients above 18 years old
* Patient able to give consent
* ASA classification: I, II, III
Exclusion criteria:
* Patients with craniofacial abnormalities
* Patients with a history of recent nasal or cranial bone fracture
* Patients with a history of recent nasal or trans-sphenoidal surgery
* Patients with nasal polyposis
* Patients with a history of epistaxis
* Patients with a history of coagulopathy or on anticoagulation therapy (including patients on Aspirin not stopped 7 days prior to presentation)
* Patients with a history of allergy to Xylometazoline or local anesthetics
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 Respiratory events (desaturation)
Timeframe: During the procedure
2
Incidence of Respiratory events (chin lift/jaw thrust)
Timeframe: During the procedure
3
Incidence of Respiratory events (mask-bag ventilation)
Timeframe: During the procedure
Trial details
NCT IDNCT04123821
SponsorAmerican University of Beirut Medical Center