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

NCT ID: NCT07159022

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2026-07-31

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.

Conditions

High Flow Nasal Cannula; Body Roundness Index

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

High Flow Nasal Cannula Oxygenation

Intervention Type: PROCEDURE

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%

Mask Oxygenation

Conventional Oxygenation will be administered through mask

Group Type: ACTIVE_COMPARATOR

Face Mask Oxygenation

Intervention Type: PROCEDURE

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

Interventions

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%

Intervention Type: PROCEDURE

Face Mask Oxygenation

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospitla

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenling Zhao

Role: CONTACT

zhao.wenling@zs-hospital.sh.cn

+86-18321299017

Other Identifiers

B2025-212

Identifier Type: -

Identifier Source: org_study_id