Clinical trial · Interventional
High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients
High-Flow Nasal Cannula for Preventing Hypoxia During Sedated Endoscopy in High-Risk Obstructive Sleep Apnea Patients: A Multicenter Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer (Diagnosis) | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Hypoxia | — | UNRESOLVED | — |
| Obstructive Sleep Apnea (OSA) | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High-flow nasal cannula Group | Device | — | UNRESOLVED |
| Regular Nasal Cannula | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- High-flow nasal cannula Group
- description
- In this group, patients use the High-flow nasal cannula
- interventionNames
- Device: High-flow nasal cannula Group
- type
- ACTIVE_COMPARATOR
- label
- Regular Nasal Cannula Group
- description
- In this group, patients use the regular nasal cannula for oxygenation.
- interventionNames
- Device: Regular Nasal Cannula
Primary outcomes (1)
- measure
- The incidence of hypoxia
- timeFrame
- Patients will be followed for the duration of hospital stay, an expected average about 2 hours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. * Patients have signed the informed consent form. Exclusion Criteria: * 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. * Confirmed pregnancy or current breastfeeding. * Known allergy to sedatives (e.g., propofol) or medical adhesives. * Multiple traumatic injuries. * Current participation in another clinical trial. * Other conditions deemed unsuitable by the investigator
References
Publications (1)
- DERIVEDXu M, Xiang S, Pi Y, Zhu Y, Chen X, Yang Q, Wu H, Deng K, Yin Y, Su D. High-flow nasal cannula oxygenation in sedated endoscopy for high-risk obstructive sleep apnea patients: study protocol for a multicentre randomised controlled trial. Ann Med. 2026 Dec;58(1):2704998. doi: 10.1080/07853890.2026.2704998. Epub 2026 Jul 27. PMID 42504139