Postoperative Management of Obstructive Sleep Apnea With CPAP vs. an Autoadjusting CPAP Device: a Randomized Controlled Single Center Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Sleep Related Hypoxemia
研究概览
简要总结
The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.
详细描述
The purpose of this study is to determine if an Autoadjusting CPAP machine is better than the regular CPAP machine in treatment of Obstructive Sleep Apnea in the postoperative setting.
Patients with known Obstructive Sleep Apnea who are on CPAP therapy at home and undergo an elective surgery (meeting specified inclusion and exclusion criteria) will be randomized to either using Autoadjusting CPAP vs their usual CPAP at their prescribed settings the night after surgery. During that night, they will be monitored with full polysomnography in their hospital bed.
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
- Triple (Participant, 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
- •Known OSA patients well-controlled by CPAP (not hypoxemic i.e. Oxygen Saturation (SaO2) ≥ 89% and post-treatment Apnea Hypopnea (AHI) <10) and compliant ( > 3 hours per night) presenting for elective inpatient surgery to MetroHealth Medical Center
- •Elective extremity or lower abdominal surgery
- •Age >18 years
排除标准
- •Surgery that may cause hypoxemia from causes other than the effect on upper airway patency e.g. any thoracic surgery, upper abdominal surgery, head and neck surgery.
- •Surgery on the upper-airway.
- •Any condition that may interfere with application of CPAP mask e.g. trauma, surgery on the face, vomiting, naso-gastric intubation etc.
- •OSA treated with a device other than CPAP e.g. Bilevel positive pressure or V-Positive Airway Pressure
- •OSA needing very high levels of CPAP i.e. > 16 cms to achieve adequate control
- •OSA or other underlying cardiopulmonary conditions that require supplemental oxygen
- •Patients with decompensated congestive heart failure or advanced Chronic Obstructive Pulmonary Disease (COPD) (FEV1<35% of predicted)
- •Patients with neuromuscular impairment
- •Patients with central sleep apnea
- •Pregnant patients
- •Decisional impaired subjects who are not able to consent
研究组 & 干预措施
Autoadjusting CPAP (VPAP auto)
The intervention will be the use of an Autoadjusting CPAP unit that will be applied to the subject during the 8 hours overnight the first night after surgery (study night). During this time, they will undergo a full night attended polysomnogram in their hospital room.
干预措施: Autoadjusting CPAP (VPAP Auto) (Device)
CPAP arm (usual care)
The intervention will be the use of the subject's own CPAP machine and this will be applied to the subject during the 8 hours overnight the first after surgery (study night). During the study night, they will undergo full polysomnography in their hospital room.
干预措施: CPAP (Device)
结局指标
主要结局
Sleep Related Hypoxemia
时间窗: On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.
次要结局
- Apnea-Hypopnea Index (AHI)(On postoperative night number 1 from 2200 to 0600. Study participation will end within 72 hours of admission.)
- Cardiopulmonary Complications(72 hours)
研究者
Dennis Auckley, MD
Associate Professor of Medicine, CWRU
MetroHealth Medical Center