Clinical trial NCT03224936: Propofolsleep - A Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy (DISE)
Official title: Propofolsleep - A Observational Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea Syndrome Under PSI Monitoring
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea, Obstructive
Electroencephalography
Echocardiography
Blood Gas Monitoring, Transcutaneous
Consciousness Monitors
Keywords: DISE
OSAS
PSI
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 18 years or older voluntary patients with an obstructive sleep apnea syndrome undergoing elective propofol induced sleep endoscopy at Charité - Universitätsmedizin Berlin Campus Charite Mitte.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: PSI
timeFrame: Duration of surgery (an average of 2 hours)
Secondary outcomes:
measure: NIRS (near-infrared spectrometry)
timeFrame: Duration of surgery (an average of 2 hours)
measure: transcutaneous CO2 (carbon dioxide)
timeFrame: Duration of surgery (an average of 2 hours)
measure: transcutaneous O2 (oxygen)
timeFrame: Duration of surgery (an average of 2 hours)
measure: Propofol
timeFrame: Duration of surgery (an average of 2 hours)
measure: Diaphragma movement
timeFrame: Duration of surgery (an average of 2 hours)
measure: blood gases
timeFrame: Duration of surgery (an average of 2 hours)
measure: heart rate
timeFrame: Duration of surgery (an average of 2 hours)
measure: blood pressure
timeFrame: Duration of surgery (an average of 2 hours)
measure: TTE (transthoracic echocardiography)
timeFrame: shortly before DISE (an average of 30 minutes)
measure: EEG parameters
timeFrame: Duration of surgery (an average of 2 hours)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin Campus Charité Mitte
Study officials:
affiliation: Charite University, Berlin, Germany
name: Sascha Treskatsch, MD, Prof
role: PRINCIPAL_INVESTIGATOR
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