Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
NCT07159022

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

Led by Shanghai Zhongshan Hospital · Updated on 2025-12-01

200

Participants Needed

1

Research Sites

47 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • ASA class 64
  • Visceral obesity with body mass index 6428 and body roundness index 6455.46
  • Patients scheduled to undergo sedated gastroscopy
Not Eligible

You will not qualify if you...

  • Life-threatening heart disease or acute myocardial infarction within 6 weeks
  • Presence of pneumothorax, pulmonary bullae, pulmonary embolism, or pulmonary oedema
  • Upper respiratory tract infection
  • Presence of tracheostomy
  • Nasal or nasopharyngeal diseases
  • Coagulation disorders or tendency to nose bleeding
  • Pregnancy
  • Thoracic surgery within the past week
  • Emergent procedure or surgery
  • Allergy to drugs used during the procedure
  • Unwillingness to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Zhongshan Hospitla

Shanghai, China

Actively Recruiting

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Research Team

W

Wenling Zhao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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