HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients (NCT05526339) | Clinical Trial Compass
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HFNO Combined With NPA Reduces Hypoxia During Sedated Gastrointestinal Endoscopy In Obese Patients
China600 participantsStarted 2022-09
Plain-language summary
Obesity is associated with adverse airway events including desaturation during deep sedation. Previous studies have suggested that high-flow nasal oxygenation may be superior to regular (low-flow) nasal cannula for prevention of hypoxia during Sedated Gastrointestinal Endoscopy in non-obesity patients. The prerequisite of high-flow nasal oxygenation is keeping airway patency. Our pervious study demonstrated that nasopharyngeal airway has the similar efficacy of jaw-lift. In present study we aimed to determine whether high-flow nasal oxygenation combined with nasopharyngeal airway could reduce the incidence of hypoxia during Sedated Gastrointestinal Endoscopy in obese patients.
Who can participate
Age range19 Years – 80 Years
SexALL
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Inclusion criteria
✓. Patients receiving selective combined upper intestinal and lower intestinal endoscopy procedure under deep sedation.
✓. Age ranging from 19 to 80, both male and female
✓. Obese patients，BMI ≥ 28kg/m\^2
✓. ASA I\~III
✓. Patients should clearly understand and voluntarily participate in the study, with signed informed consent.
Exclusion criteria
✕. Patients with acute respiratory infection in the last 2 weeks
✕. Patients with nasal congestion, epistaxis, recent nasal trauma, recent nasal surgery
✕. hypoxia, defined as oxygen saturation measured by pulse oximetry (SpO2) ≤ 95% before preoxygenation.
✕. Common advanced gastrointestinal endoscopy procedures meeting eligibility criteria included cholangiopancreatography, endoscopic ultrasound procedures, endoscopic mucosal resection and endoscopic retrograde cholangiopancreatography (ERCP) procedures.
What they're measuring
1
The incidence of hypoxia
Timeframe: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
✕. coagulation disorders or platelets \< 100\*10\^9/L
✕. Have serious heart diseases such as severe arrhythmia, heart failure, Adams Stokes Disease, unstable angina pectoris, myocardial infarction in the last 6 months, history of tachycardia / bradycardia requiring medical treatment, third degree atrioventricular block or QTC interval ≥ 450ms (corrected according to fridericia's formula), or exercise tolerance \< 4mets
✕. Allergy to eggs, soy products, opioids and other drugs, propofol, etc.
✕. Participated in other clinical trials as a subject within 3 months