Propofolsleep - a Observational Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy in Patients with Obstructive Sleep Apnea Syndrome Under PSI Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- PSI
研究概览
简要总结
While Drug Induced Sleep Endoscopy (DISE) in patients with obstructive sleep apnea syndrome (OSAS) apnea and hypopnea occur. Because of the induced phases of apnea in a controlled setting it is possible to evaluate the related pathophysiology of apnea. We plan to correlate the Patient State Index (PSI) and other physiologic parameters with phases of apnea and hypopnea.
详细描述
DISE is a standard method in diagnosis of OSAS and its specific localisation and severity. 20 patients with polysomnographic diagnosed OSAS will be enrolled in this prospective observational study. All patients would get a DISE because of the before mentioned reasons (localisation and severity) although they wouldn't participate in this study. They will get a 24-h-RR (blood pressure)-measurement, a transthoracic echocardiography, a peak-flow-test and routine lab examination including troponin and proBNP before the examination. Furthermore they have to fill out the Epworth Sleepiness Scale questionaire.
Before starting the DISE a standard-monitoring (Electrocardiography, pulse oximetry, non-invasive blood pressure, patient state index, near infrared spectroscopy, transcutaneous CO2 (carbon dioxide), invasive blood pressure) will be established. After applying the monitoring the DISE is started by target controlled infusion (Marsh Model) with a sighted goal-concentration of 3.0 µg/ml Propofol in 5 minutes. While the examination a stabile snoring-phase with apnoea/hypopnoea is needed. In this moment a video-endoscopy is started to quantify the level of obstruction. After DISE the sedation will end and the patients will be transported to the recovery room or postanesthesia care unit (PACU). For specific order of events a video recording of the DISE will be realized.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •informed written consent
- •age of 18 years or older
- •no participation in other prospective interventional studies
- •OSAS with a polysomnographic shown AHI (apnea-hypopnea-index) of 15/h or more
排除标准
- •no written informed consent
- •allergies against study medication
- •ASA (american society of anesthesiologists) class 4 or higher
- •neurodegenerative CNS (central nerve system) or muscle diseases
- •pregnant or breastfeeding patients
- •25 % or more central or mixed apneas in polysomnography
结局指标
主要结局
PSI
时间窗: Duration of surgery (an average of 2 hours)
Depth of sedation is monitored with a SEDline electroencephalograph based monitor that displays patient state index (PSI).
次要结局
- transcutaneous O2 (oxygen)(Duration of surgery (an average of 2 hours))
- NIRS (near-infrared spectrometry)(Duration of surgery (an average of 2 hours))
- blood gases(Duration of surgery (an average of 2 hours))
- Propofol(Duration of surgery (an average of 2 hours))
- transcutaneous CO2 (carbon dioxide)(Duration of surgery (an average of 2 hours))
- heart rate(Duration of surgery (an average of 2 hours))
- blood pressure(Duration of surgery (an average of 2 hours))
- TTE (transthoracic echocardiography)(shortly before DISE (an average of 30 minutes))
- Diaphragma movement(Duration of surgery (an average of 2 hours))
- EEG parameters(Duration of surgery (an average of 2 hours))
研究者
Sascha Treskatsch
Deputy head of department Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK
Charite University, Berlin, Germany