Esophageal Cancer, Gastric Cancer (Diagnosis), Hypoxia, Obstructive Sleep Apnea (OSA)
Conditions
Keywords
Sedation, Hypoxia, Obstructive Sleep Apnea (OSA), Gastrointestinal Endoscopy
Brief summary
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.
Interventions
DEVICEHigh-flow nasal cannula Group
Using High-flow nasal cannula oxygenation
DEVICERegular Nasal Cannula
Using regular nasal cannula for oxygenation
Sponsors
Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 75% ≤ SpO2 \< 90% for \<60 s |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of sub-clinical respiratory depression | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | 90% ≤ SpO2 \< 95% |
| The incidence of severe hypoxia | Patients will be followed for the duration of hospital stay, an expected average about 2 hours | SpO2 \< 75% or 75% ≤ SpO2 \< 90% for ≥60 s |
Countries
China
Contacts
CONTACTDiansan Su, Chief Physician
Outcome results
None listed