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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
200
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%
conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute
Zhongshan Hospitla
Shanghai, China
RECRUITINGIncidence of hypoxia
SpO2\<90%
Time frame: From sedation with propofol to the end of the gastroscopy
Incidence of subclinical respiratory depression
90%≤SpO2\<95%
Time frame: From sedation with propofol to the end of the gastroscopy
Severe hypoxia
SpO2\<75% for any duration or 75%≤SpO2\<90% for \>60 s
Time frame: From sedation with propofol to the end of the gastroscopy
Serious cardiac events
Hypotension: Mean arterial pressure (MAP) \< 65 mmHg; hypertension: MAP \> 90 mmHg
Time frame: Through gastroscopy completion, an average of 10-15 minutes
Serious adverse respiratory events
Apnea, tracheospasm, larynx spasm
Time frame: Through gastroscopy completion, an average of 10-15 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.