NCT07159022 High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy
| NCT ID | NCT07159022 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai Zhongshan Hospital |
| Condition | High Flow Nasal Cannula |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-08-31 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2025-08-31 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
During sedated gastroscopy, the insertion of the fiberscope and gastric distension required to perform the examination may induce respiratory depression, airway obstruction, and decreased chest wall compliance. Patients with obesity, especially visceral fat, have poor lung and chest wall compliance, lower lung capacity and functional residual capacity, and an unbalanced ventilation-to-perfusion ratio. Thus, obese patients are at a high risk of hypoxemia. Increasing evidence supports the use of High-flow nasal cannula (HFNC) oxygenation in obese patients during sedated gastrointestinal endoscopy. Obesity, especially visceral obesity, is an established risk factor associated with all-cause mortality. Body roundness index (BRI) is a newer anthropometric measure associated with identification of high-risk individuals. Owing to the limited evidence, we designed this unblinded randomized controlled trial to assess whether HFNC, compared to standard mask oxygenation, improves oxygenation at the end of the procedure (primary endpoint) in patients with visceral obesity.
Eligibility Criteria
Inclusion Criteria: * ASA class ≤Ⅲ * Visceral obesity（body mass index≥28 and BRI ≥5.46） * Patients who will undergo sedated gastroscopy Exclusion Criteria: * Life-threatening heart disease or acute myocardial infarction within 6 weeks * Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema * Upper respiratory tract infection * Presence of tracheostomy * Nasal or nasopharyngeal diseases * Coagulation disorders or a tendency of nose bleeding * Pregnancy * Recent (within 1 week) thoracic surgery * Emergent procedure or surgery * Allergy to drugs used during the procedure * Unwillingness to participate in the study
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07159022 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying High Flow Nasal Cannula. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07159022 currently recruiting?
Yes, NCT07159022 is actively recruiting participants. Contact the research team at zhao.wenling@zs-hospital.sh.cn for enrollment information.
Where is the NCT07159022 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07159022 clinical trial?
NCT07159022 is sponsored by Shanghai Zhongshan Hospital. The trial plans to enroll 200 participants.