Charité - Universitätsmedizin Berlin Campus Charité Mitte
Berlin, State of Berlin, 10115, Germany
NCT Number: NCT03224936
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.
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Notify Me18 year and older
All sexes
Observational
Berlin, State of Berlin, 10115, Germany
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The PSI delivered by Masimo Root (Sedline) will be measured in all patients.
Time frame: 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).
Time frame: Duration of surgery (an average of 2 hours)
Near-infrared spectrometry in % of left and right hemisphere
Time frame: Duration of surgery (an average of 2 hours)
Measured at the chest.
Time frame: Duration of surgery (an average of 2 hours)
Measured at the center of the chest.
Time frame: Duration of surgery (an average of 2 hours)
Total amount of administered propofol.
Time frame: Duration of surgery (an average of 2 hours)
Diaphragma movement is measured by ultrasound.
Time frame: Duration of surgery (an average of 2 hours)
Arterial blood gas is obtained from an arterial line.
Time frame: Duration of surgery (an average of 2 hours)
by ECG.
Time frame: Duration of surgery (an average of 2 hours)
NIBP and IBP.
Time frame: shortly before DISE (an average of 30 minutes)
Parameters of left and right ventricular function, as well as function of heart valves before DISE.
Time frame: Duration of surgery (an average of 2 hours)
Parameters measured by the Sedline monitor
Charite University, Berlin, Germany
Other
Propofolsleep - A Observational Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea Syndrome Under PSI Monitoring
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