High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High Flow Nasal Cannula Oxygenation, Face Mask Oxygenation.
- Who it may be relevant to
- Registry conditions: High Flow Nasal Cannula, Body Roundness Index. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
High Flow Nasal Cannula and Mask Oxygenation in Patients With Visceral Obesity Undergoing Sedated Gastroscopy: A Randomized Controlled Trial.
Overview
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.
Interventions
- Procedure 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% - Procedure Face Mask Oxygenation
conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute
Primary outcome measures
- Incidence of hypoxia [Time frame: From sedation with propofol to the end of the gastroscopy]
Secondary outcome measures (4)
- Incidence of subclinical respiratory depression [Time frame: From sedation with propofol to the end of the gastroscopy]
- Severe hypoxia [Time frame: From sedation with propofol to the end of the gastroscopy]
- Serious cardiac events [Time frame: Through gastroscopy completion, an average of 10-15 minutes]
- Serious adverse respiratory events [Time frame: Through gastroscopy completion, an average of 10-15 minutes]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Zhongshan Hospitla — Shanghai
Identifiers
NCT: NCT07159022 · B2025-212