Does a Semi-upright Position During Sleep Prevent Worsening of Severity of Obstructive Sleep Apnea (OSA) on the Second Postoperative Night in Patients Following Elective Inpatient Surgery? A Two Arm, Parallel, Randomized, Controlled, First Stage Proof of Concept Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 6
- 主要终点
- Comparison of worsening of severity of OSA using the Apnea-hypopnea index (AHI) as determined by a portable polysomnography study from baseline (preoperatively) to the second postoperative night.
研究概览
简要总结
Our main objective is to perform an explanatory, first stage proof of concept, randomized controlled trial to determine whether a semi-upright patient position versus a supine position while asleep in the postoperative period helps decrease the worsening of AHI in patients diagnosed with OSA and compare this to usual care (i.e. supine patient positioning while asleep).
The investigators will evaluate whether a semi-upright position reduces: worsening of AHI (as measured with a portable PSG) on the second postoperative night (POD2); oxygen desaturation index (using a portable oxygen saturation monitor, oxygen desaturation defined as >4% change below baseline lasting for 10 seconds); REM sleep related change in AHI at baseline and POD2.; major and minor perioperative complications on postoperative day POD1, POD2, at discharge and POD 30.; length of hospital stay and readmission within 30 days; and patient satisfaction score on POD30
详细描述
The proposed study is to determine whether patient positioning in supine or semi-sitting position can effectively control the worsening of OSA see in the postoperative period.
The study patient will be randomized to semi-sitting position (45 degrees incline) group or supine (0 degrees incline) group. Patients will undergo a portable sleep study on the first or second postoperative night. They will also be monitored with wristwatch oximeter pre and postoperatively according to the study protocol. Patients will be managed according to the routine care determined by the health care team. There will be no change in the clinical management of patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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 patients (18 years and above),
- •ASA physical status I to IV,
- •Undergoing elective inpatient surgery with obstructive sleep apnea (as determined by initial screening using STOP-Bang questionnaire and if at high risk (>3 points),
- •Confirmed by an Apnea-hypopnea index (AHI) >5 using a diagnostic home portable polysomnography)
排除标准
- •Patients previously diagnosed as OSA and on continuous positive airway pressure (CPAP) device;
- •Known cervical, shoulder, spine abnormalities, and/or chronic pain predisposing to difficulty in maintaining a sitting position; or
- •Previous intervention for OSA (e.g., uvulopalatopharyngoplasty, bariatric surgery); where sitting position is contraindicated postoperatively such as hip or spine surgery, hemodynamic instability; ambulatory surgery i.e. planned discharge on the same day of surgery.
研究组 & 干预措施
Semi-upright position
Semi-upright position defined as 45 degrees incline from horizontal of the patients bed during nocturnal sleep, for two postoperative nights. Daytime naps will be excluded. A regular pillow may be used by the patients based upon the level of comfort and also to support the head in a neutral position.
干预措施: Semi-upright position (Other)
Control group (Supine position)
In this group patients' bed will be set into Supine/0 degree angle during sleep in the night time. Patient will be managed according to routine care
干预措施: Supine position (Other)
结局指标
主要结局
Comparison of worsening of severity of OSA using the Apnea-hypopnea index (AHI) as determined by a portable polysomnography study from baseline (preoperatively) to the second postoperative night.
时间窗: 3days
The AHI is used as a surrogate outcome to establish the diagnosis of OSA (AHI\>5) and severity of OSA as per the guidelines from American Academy of Sleep Physicians (AASP).5 It is a continuous outcome and is measured by counting the number of apneas (complete cessation of airflow for more than 10 s) and hypopneas (airflow reduction more than 50%) despite continuing breathing efforts and thus differentiating from central events (absence of breathing efforts). The relationship of AHI to clinical outcomes of relevance has been well established in the literature.
次要结局
- Major and minor perioperative complications and length of hospital stay on postoperative day (POD) 1, POD2, at discharge and POD 30 will be recorded based on chart review.(30 days)
- Hospital stay(30 days)
研究者
Dr. Frances Chung
Staff Anesthesiologist
University Health Network, Toronto