Fact CheckerSign in

NCT07159022Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 1 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
200 (estimated)
First submitted
27 Aug 2025
Start date
31 Aug 2025
Primary completion date
30 Jun 2026
Lead sponsor
Shanghai Zhongshan Hospital
Diseases
Obesity
NCT number
NCT07159022

What you commit to

  • Study type: Interventional
  • Planned participants: 200
  • From 31 Aug 2025 to the primary completion date, 30 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Recent (within 1 week) thoracic surgery
  • Emergent procedure or surgery

Other illness

  • Life-threatening heart disease or acute myocardial infarction within 6 weeks
  • Upper respiratory tract infection
  • Nasal or nasopharyngeal diseases
  • Coagulation disorders or a tendency of nose bleeding
  • Allergy to drugs used during the procedure

Other

  • Presence of pneumothorax or pulmonary bullae, pulmonary embolism, pulmonary oedema
  • Presence of tracheostomy
  • Pregnancy
  • Unwillingness to participate in the study

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Zhongshan Hospitla
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.