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

NCT07159022 | Recruiting

• 1 other identifier: B2025-212
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of hypoxia

  SpO2\<90%

  From sedation with propofol to the end of the gastroscopy

Secondary Outcomes (4)

• Incidence of subclinical respiratory depression

  From sedation with propofol to the end of the gastroscopy

• Severe hypoxia

  From sedation with propofol to the end of the gastroscopy

• Serious cardiac events

  Through gastroscopy completion, an average of 10-15 minutes

• Serious adverse respiratory events

  Through gastroscopy completion, an average of 10-15 minutes

Study Arms (2)

High Flow Nasal Cannula Oxygenation

EXPERIMENTAL

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.

Procedure: High Flow Nasal Cannula Oxygenation

Mask Oxygenation

ACTIVE COMPARATOR

Conventional Oxygenation will be administered through mask

Procedure: Face Mask Oxygenation

Interventions

High Flow Nasal Cannula Oxygenation 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%

High Flow Nasal Cannula Oxygenation

Face Mask Oxygenation PROCEDURE

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

Mask Oxygenation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class ≤Ⅲ
• Visceral obesity（body mass index≥28 and BRI ≥5.46）
• Patients who will undergo sedated gastroscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospitla

Shanghai, China

RECRUITING

Central Study Contacts

Wenling Zhao

CONTACT

+86-18321299017; zhao.wenling@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 8, 2025
• Study Start: August 31, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

CN (1)