Use of the Boussignac CPAP System Immediately Following Extubation to Improve Lung Function in Adults With Moderate to Severe Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- percent forced vital capacity %(FVC)
研究概览
简要总结
The purpose of this study is to assess the efficacy of the Boussignac positive airway pressure system (a mask) applied immediately following post-operative extubation in improving lung function in patients with obstructive sleep apnea (OSA). Assessments will be done before surgery and then at 1, 2 and 24 hours following extubation and will be compared to standard care for perioperative airway support. The study aims to give a broader and more inclusive picture (than the current literature) in terms of whether the Boussignac CPAP system should be considered for utilization by anesthesiologists caring for surgical patients with OSA.
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
- 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
- •> 18 years of age
- •ASA II-IV
- •Previous diagnosis of moderate to severe obstructive sleep apnea
- •diagnosed via polysomnography
- •BMI < 40
- •scheduled for an abdominal or peripheral surgical procedure requiring endotracheal intubation and admission to hospital
排除标准
- •BMI > 40
- •Age <18 years
- •inability to provide signed informed consent
- •intra-thoracic
- •head or neck surgery
- •contraindication for immediate post-extubation application of CPAP
- •not expected to be eligible for timely extubation following the surgical procedure
研究组 & 干预措施
Boussignac CPAP device
Patients previously diagnosed with obstructive sleep apnea and who are undergoing abdominal or peripheral surgery will have the Boussignac CPAP mask applied for 1 hour starting immediately post-extubation
干预措施: Boussignac CPAP device (Device)
standard CPAP
Patients previously diagnosed with obstructive sleep apnea who are undergoing peripheral or abdominal surgical procedures will receive the standard-of-care for obstructive sleep apnea. This typically involves CPAP application only at night
干预措施: standard CPAP (Device)
结局指标
主要结局
percent forced vital capacity %(FVC)
时间窗: 24 hours postoperatively
%FVC will be assessed 24 hours postoperatively in patients who received the Boussignac CPAP mask immediately post-extubation and these values compared to those of patients who received the standard-of-care treatment for obstructive sleep apnea
次要结局
- % forced expiratory volume in 1 second (FEV1)(1,2 and 24 hours post-operatively)
研究者
Dr. Kim Turner
Principal Investigator
Queen's University