NCT05175573已完成不适用
Comparison of Hypoxemia During Deep Sedation Procedures Between Oxygen Face Mask and the SuperNO2VA Et: a Randomized Controlled Trial. iOXIGENATe Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Hypoxemia
研究概览
简要总结
The primary objective of the study is to prospectively and randomly compare the incidence, duration, and severity of oxygen desaturation between a nasal mask with nasal positive airway pressure (PAP) versus oxygen therapy with a facemask during procedural deep sedation in patients considered high risk for hypoxia (ie: BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years of age or older
- •Patients undergoing procedural deep sedation
- •American Society of Anesthesiology (ASA) Physical Status I-III
- •BMI ≥30 kg/m2 or documented Obstructive Sleep Apnea
- •Has provided written informed consent
- •Difficult airway
排除标准
- •Acute exacerbation of respiratory disorders, including COPD and asthma
- •Emergent procedures
- •Previous enrollment in this study
- •Inability to provide informed consent
- •History of allergic reaction to Propofol
- •Tracheostomy
- •Exclusion criteria: deep sedation procedures that require intra-oral instrumentation (ie: EGD, transesophageal echocardiography
结局指标
主要结局
Hypoxemia
时间窗: Oxygen saturation below 90% for >15 seconds during procedure
Compare the percentage of time spent with oxygen saturation below 90%.
次要结局
- Oxygen desaturation(Oxygen saturation below 90% for >15 seconds during procedure)
- Sedation(Total duration of procedure)
- Airway maneuvers(Total duration of procedure)
- Procedure Duration(Total duration of procedure)
- Patient Tolerance(Total duration of procedure and post procedure in PACU (scale: None, Mild, Moderate, Severe; multiple choice: Yes or No)))
- Hypoxemic Episodes(Oxygen saturation below 90% for >15 seconds during procedure)
- Anesthesiologist Satisfaction(Total duration of procedure)
- Patient Satisfaction(Total duration of procedure and post procedure in PACU (scale: 0 to 10; 0 - poor, 10 - excellent))
- Surgeon Satisfaction(Total duration of procedure)
- Cardiac Complications(Total duration of procedure and post procedure in PACU)
- Procedural Interruptions(Total duration of procedure)
- Recovery(Total duration of post procedure in PACU)
研究者
研究点 (2)
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