High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University
About this trial
Hypoxia represents the most frequent adverse event during propofol-sedated gastrointestinal endoscopy. The STOP-BANG questionnaire serves as a widely adopted, straightforward tool for screening obstructive sleep apnea (OSA) risk, with a score ≥5 identifying high-risk OSA patients who are particularly susceptible to hypoxia under sedation. Although preliminary research from our team suggests that High-Flow Nasal Cannula (HFNC) may lower the incidence of hypoxemia, evidence remains limited and inconsistent in studies specifically targeting high-risk OSA populations. Therefore, this multicenter randomized controlled trial aims to evaluate whether HFNC can effectively reduce the occurrence of hypoxia during sedated gastrointestinal endoscopy in patients identified as high-risk for OSA.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years.
STOP-Bang score ≥5.
Scheduled for sedated gastrointestinal endoscopy (gastroscopy, colonoscopy, or combined gastroscopy + colonoscopy).
The estimated duration of the procedure does not exceed 45 minutes.
Disqualifiers
Coagulation disorders or bleeding tendency (e.g., oral/nasal bleeding risk, mucosal injury, space-occupying obstructions).
Active upper respiratory tract infection (oral, nasal, or pharyngeal), or fever (core temperature >37.5°C).
Chronic obstructive pulmonary disease or other acute/chronic pulmonary diseases requiring long-term or intermittent oxygen therapy, or preoperative SpO₂ ≤ 92% on room air.
Severe organ dysfunction, including: Cardiac insufficiency (<4 METs), Severe renal insufficiency (requiring dialysis), Diagnosed severe hepatic insufficiency, Increased intracranial pressure, ASA physical status ≥ IV.
Trial design
Design model
Parallel
Treatments tested in this trial
High-flow nasal cannula Group
DeviceUsing High-flow nasal cannula oxygenation
Regular Nasal Cannula
DeviceUsing regular nasal cannula for oxygenation
Treatment groups
600 Participants
are divided into 2 treatment groupsGroup A: High-flow nasal cannula GroupExperimental treatment 1 intervention
Group B: Regular Nasal Cannula GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of hypoxia
75% ≤ SpO2 \< 90% for \<60 s
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursSecondary outcomes
1
The incidence of sub-clinical respiratory depression
90% ≤ SpO2 \< 95%
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hours2
The incidence of severe hypoxia
SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursOther outcomes
1
The incidence of other adverse events
Other adverse events recorded by tools proposed by the World Society of Intravenous Anesthesia International Sedation Task Force
Time frame
Patients will be followed for the duration of hospital stay, an expected average about 2 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov