NCT01002599Unknown不适用
Does BoussignacTM CPAP Compared to Venturi Mask Improve Oxygenation and Pulmonary Function in Morbidly Obese Patients Undergoing Bariatric Surgery?
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- PaO2/FiO2 ratio (PF ratio) immediately on arrival to postanesthesia care unit, 1 hour, 2 hours, and 24 hours post-extubation.
研究概览
简要总结
This is a randomized controlled study in which morbidly obese patients undergoing bariatric surgery will be recruited in the preoperative clinic. Patients will be randomized into 2 groups to receive oxygen with Boussignac TM continuous positive airway pressure (CPAP) or conventional Venturi mask postoperatively immediately after extubation. The objective of the study is to examine if Boussignac TM CPAP results in improved oxygenation versus Venturi face mask when it is applied immediately after extubation in morbidly obese patients post bariatric surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged between 18 to 75 years of age
- •American Society of Anesthesiologists' (ASA) class I to III
- •Morbidly obese with a body mass index > 35 kg/m2
- •Patients undergoing bariatric surgery
排除标准
- •Patient refusal
- •Pre-existing cardiac failure, asthma, chronic obstructive pulmonary disease or interstitial pulmonary disease
- •Systolic blood pressure less than 90 mmHg despite pharmacotherapy
- •Hb < 70 g/L
- •Impaired gastric emptying
- •Severe psychiatric disorder
- •Language barrier
结局指标
主要结局
PaO2/FiO2 ratio (PF ratio) immediately on arrival to postanesthesia care unit, 1 hour, 2 hours, and 24 hours post-extubation.
时间窗: 24 hours
次要结局
未报告次要终点
研究者
研究点 (2)
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