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Clinical Trials in China / NCT07159022
Recruiting Not applicable

High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy

NCT07159022 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Zhongshan Hospital
Phase
Not applicable
Started
2025-08-31
Last updated
2025-12-01

Condition(s) studied

High Flow Nasal CannulaBody Roundness Index

Investigational drug(s) / intervention(s)

High Flow Nasal Cannula OxygenationFace Mask Oxygenation

High Flow Nasal Cannula Oxygenation: High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%

Face Mask Oxygenation: conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute

Study 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

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospitla Shanghai China Recruiting

More Shanghai Zhongshan Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07159022 on ClinicalTrials.gov ↗ ← All trials in China