NCT07159022Recruiting
High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy
High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.
Source: ClinicalTrials.gov · Last updated 1 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 27 Aug 2025
- Start date
- 31 Aug 2025
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- Shanghai Zhongshan Hospital
- Diseases
- Obesity
- NCT number
- NCT07159022
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 31 Aug 2025 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent (within 1 week) thoracic surgery
- Emergent procedure or surgery
Other illness
- Life-threatening heart disease or acute myocardial infarction within 6 weeks
- Upper respiratory tract infection
- Nasal or nasopharyngeal diseases
- Coagulation disorders or a tendency of nose bleeding
- Allergy to drugs used during the procedure
Other
- Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema
- Presence of tracheostomy
- Pregnancy
- Unwillingness to participate in the study
Who the study is looking for
- ASA class ≤Ⅲ
- Visceral obesity(body mass index≥28 and BRI ≥5.46)
- Patients who will undergo sedated gastroscopy
Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zhongshan Hospitla Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.