High-flow nasal oxygen versus face mask oxygen for sedated gastroscopy in people with visceral obesity
High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.
This test sees if using high-flow nasal oxygen instead of a standard face mask keeps oxygen levels better during sedated gastroscopy for people with visceral obesity.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07159022 on ClinicalTrials.gov |
What this trial studies
This is an unblinded randomized controlled comparison of high-flow nasal cannula (HFNC) oxygenation versus standard face mask oxygenation in patients with visceral obesity undergoing sedated gastroscopy. Eligible adults have BMI ≥28 and a body roundness index (BRI) ≥5.46 and are ASA class I–III. Patients are randomly assigned to receive HFNC or mask oxygen during the procedure and monitored for oxygenation, hypoxemic events, and related airway complications. The trial is being conducted at Zhongshan Hospital in Shanghai and focuses on intra-procedural respiratory outcomes.
Who should consider this trial
Good fit: Adults with visceral obesity (BMI ≥28 and BRI ≥5.46), ASA class I–III, who are scheduled for sedated gastroscopy are the ideal candidates.
Not a fit: People without visceral obesity or those with contraindications such as recent thoracic surgery, nasal/nasopharyngeal disease, tracheostomy, severe unstable heart or pulmonary conditions, bleeding disorders, or pregnancy are unlikely to benefit from this comparison.
Why it matters
Potential benefit: If successful, HFNC could reduce episodes of low oxygen and improve safety during sedated gastroscopy in people with visceral obesity.
How similar studies have performed: Some prior small studies and clinical experience suggest HFNC can improve oxygenation during sedated endoscopy in obese patients, but high-quality evidence remains limited.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai
- Zhongshan Hospitla — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Wenling Zhao
- Email: zhao.wenling@zs-hospital.sh.cn
- Phone: +86-18321299017
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.