Non-Supine Positioning in Treatment of Surgical Patients With Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Acute Hypoxic Index (AHI)
研究概览
简要总结
The study aims to evaluate the effect of non-supine positioning in the treatment of surgical patients with obstructive sleep apnea. The hypothesis is that non-supine positioning will result in a decrease in acute hypoxic events, defined as the number of apneas/hypopneas per hour of sleep.
详细描述
This is a prospective, randomized controlled trial that will comprise of two stages. Stage 1 is a pilot study of 30 patients at high risk or diagnosed with obstructive sleep apnea who are scheduled for routine surgery. These patients will be randomized 1:1:1 to standard of care (0 degree bed angle), 30 degree bed angle, or 60 degree bed angle. Acute hypoxic events will be analyzed pre and post-op in the randomly assigned bed position. PACU nurses will also be surveyed for patient-favored non-supine positioning (30 vs. 60 degrees). Stage 2 will be a larger, powered trial to evaluate the efficacy of just one bed angle (30 or 60 degrees) based on the Stage 1 results.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 1 night postoperative hospital stay
- •More than 18 and less than 80 years old
- •Identified as high risk of OSA (SACS > 15) or a history of OSA without CPAP treatment
排除标准
- •Unwilling or unable to give informed consent
- •Undergoing nasal, eye, head/neck surgery, intracranial or cardiac/thoracic surgery
- •Currently undergoing treatment for sleep apnea including CPAP
- •Requiring prolonged postoperative ventilation
- •NYHA functional class III and IV
- •Valvular heart disease, dilated cardiomyopathy, implanted cardiac pacemaker, or unstable angina
- •Myocardial infarction or cardiac surgery within 3 months
- •Chronic obstructive pulmonary disease, or asthma
- •Presence of tracheostomy, facial, neck, or chest wall abnormalities
- •Abdominal aortic aneurysm surgery, chemotherapy, or immunosuppressive therapy within 3 months
- •Visiting preoperative clinic less than 3 days before surgery
- •Requiring postoperative nasogastric tube
研究组 & 干预措施
Control
standard of care positioning (0 degree)
干预措施: bed positioning (Other)
30 degree
30 degree bed positioning
干预措施: bed positioning (Other)
60 degree
60 degree bed positioning
干预措施: bed positioning (Other)
结局指标
主要结局
Acute Hypoxic Index (AHI)
时间窗: 3 days
study will look at the effect of bed positioning on Acute Hypoxic Index (AHI), which is defined as the number of apneas/hypopneas per hour of sleep
次要结局
未报告次要终点