High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• ASA class ≤Ⅲ

• Visceral obesity(body mass index≥28 and BRI ≥5.46)

• Patients who will undergo sedated gastroscopy

Locations
Other Locations
China
Zhongshan Hospitla
RECRUITING
Shanghai
Contact Information
Primary
Wenling Zhao
zhao.wenling@zs-hospital.sh.cn
+86-18321299017
Time Frame
Start Date: 2025-08-31
Estimated Completion Date: 2026-07-31
Participants
Target number of participants: 200
Treatments
Experimental: High Flow Nasal Cannula Oxygenation
High Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min.
Active_comparator: Mask Oxygenation
Conventional Oxygenation will be administered through mask
Related Therapeutic Areas
Sponsors
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov