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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Flow Nasal Cannula Oxygenation | Experimental | High Flow Nasal cannula is a system to deliver heated and humidified oxygen with an inspired oxygen fraction between 21 and 100% through large bore nasal cannula. The system delivers a flow up to 60 liters/min. |
|
| Mask Oxygenation | Active Comparator | Conventional Oxygenation will be administered through mask |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High Flow Nasal Cannula Oxygenation | Procedure | 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% |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of hypoxia | SpO2<90% | From sedation with propofol to the end of the gastroscopy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of subclinical respiratory depression | 90%≤SpO2<95% | From sedation with propofol to the end of the gastroscopy |
| Severe hypoxia | SpO2<75% for any duration or 75%≤SpO2<90% for >60 s |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenling Zhao | Contact | +86-18321299017 | zhao.wenling@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospitla | Recruiting | Shanghai | China |
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| Face Mask Oxygenation | Procedure | conventional oxygen therapy will be administered through common mask with a flow up to 6 Liters per minute |
|
| From sedation with propofol to the end of the gastroscopy |
| Serious cardiac events | Hypotension: Mean arterial pressure (MAP) < 65 mmHg; hypertension: MAP > 90 mmHg | Through gastroscopy completion, an average of 10-15 minutes |
| Serious adverse respiratory events | Apnea, tracheospasm, larynx spasm | Through gastroscopy completion, an average of 10-15 minutes |