跳至主要内容
临床试验/NCT04731168
NCT04731168已完成不适用

Prevention of Sleep Apnea After General Anaesthesia With a Mandibular Advancement Device: a Randomized Controlled Trial

Centre Hospitalier Universitaire Vaudois2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eric Albrecht

Program director of regional anaesthesia

Centre Hospitalier Universitaire Vaudois

研究点 (2)

Loading locations...

相似试验