Propofolsleep - A Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy (DISE)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Propofolsleep - A Observational Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea Syndrome Under PSI Monitoring

Conditions
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Sleep Apnea, Obstructive, Electroencephalography, Echocardiography, Blood Gas Monitoring, Transcutaneous, Consciousness Monitors

Intervention / Treatment
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* Device: PSI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| DISE group<br>All patients in this study group will receive a propofol PSI controlled DISE (drug induced sleep endoscopy). | Device: PSI<br>* The PSI delivered by Masimo Root (Sedline) will be measured in all patients.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSI | Depth of sedation is monitored with a SEDline electroencephalograph based monitor that displays patient state index (PSI). | Duration of surgery (an average of 2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIRS (near-infrared spectrometry) | Near-infrared spectrometry in % of left and right hemisphere | Duration of surgery (an average of 2 hours) | 
| transcutaneous CO2 (carbon dioxide) | Measured at the chest. | Duration of surgery (an average of 2 hours) | 
| transcutaneous O2 (oxygen) | Measured at the center of the chest. | Duration of surgery (an average of 2 hours) | 
| Propofol | Total amount of administered propofol. | Duration of surgery (an average of 2 hours) | 
| Diaphragma movement | Diaphragma movement is measured by ultrasound. | Duration of surgery (an average of 2 hours) | 
| blood gases | Arterial blood gas is obtained from an arterial line. | Duration of surgery (an average of 2 hours) | 
| heart rate | by ECG. | Duration of surgery (an average of 2 hours) | 
| blood pressure | NIBP and IBP. | Duration of surgery (an average of 2 hours) | 
| TTE (transthoracic echocardiography) | Parameters of left and right ventricular function, as well as function of heart valves before DISE. | shortly before DISE (an average of 30 minutes) | 
| EEG parameters | Parameters measured by the Sedline monitor | Duration of surgery (an average of 2 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DISE, OSAS, PSI