Prevention of Sleep Apnea After General Anaesthesia With a Mandibular Advancement Device: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Supine AHI
研究概览
简要总结
Sleep apneic episodes increase after general anaesthesia up to the third postoperative night. A mandibular advancement device, called MAD, is a small device that is inserted in the patient's mouth during the night and allows the advancement of the mandible, preventing sleep apneic episodes. The objective of this randomized controlled trial is to determine whether a MAD reduces the impact of general anaesthesia on the increase of the sleep apneic episodes in the postoperative period. All patients will have their sleep-related respiratory data measured using a portable respiratory polygraphy recorder (ResMed Embletta® system). This portable recorder allows a non-invasive recording of nasal airflow through a nasal cannula, oxygen saturation (SpO2) via finger pulse oximetry, respiratory efforts through thoracic and abdominal belts, and body position.
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
- Double (Investigator, 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
- •adult patient undergoing any lower limb surgery
排除标准
- •continuous positive airway pressure (CPAP) treatment for obstructive sleep apnoea,
- •presence of severe respiratory or cardiovascular disease
- •preoperative consumption of benzodiazepine,
- •chronic use of opioids > 30 mg/day morphine equivalent
- •patient known for malignant hyperthermia
结局指标
主要结局
Supine AHI
时间窗: Postoperative night 1
Apnea-Hypopnea index in the supine position
次要结局
- OAI(Postoperative night 1)
- CAI(Postoperative night 1)
- ODI(Postoperative night 1)
- Hypopnea index(Postoperative night 1)
- Global AHI(Postoperative night 1)
- Respiratory Rate(Postoperative night 1)
- Percentage of supine time(Postoperative night 1)
研究者
Eric Albrecht
Program director of regional anaesthesia
Centre Hospitalier Universitaire Vaudois
