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

Fudan University

Status: Enrolling

Conditions: High Flow Nasal Cannula; Body Roundness Index

Treatments: Procedure: Face Mask Oxygenation; Procedure: High Flow Nasal Cannula Oxygenation

Study type: Interventional

Funder types: Other

Identifiers

NCT07159022

B2025-212

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

High Flow Nasal Cannula Oxygenation

Experimental group

Description:

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.

Treatment:

Procedure: High Flow Nasal Cannula Oxygenation

Mask Oxygenation

Active Comparator group

Description:

Conventional Oxygenation will be administered through mask

Treatment:

Procedure: Face Mask Oxygenation