Sleep Apnea, Obstructive, Electroencephalography, Echocardiography, Blood Gas Monitoring, Transcutaneous, Consciousness Monitors
Conditions
Keywords
DISE, OSAS, PSI
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.
Interventions
DEVICEPSI
The PSI delivered by Masimo Root (Sedline) will be measured in all patients.
Sponsors
Charite University, Berlin, Germany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PSI | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| transcutaneous CO2 (carbon dioxide) | Duration of surgery (an average of 2 hours) | Measured at the chest. |
| transcutaneous O2 (oxygen) | Duration of surgery (an average of 2 hours) | Measured at the center of the chest. |
| Propofol | Duration of surgery (an average of 2 hours) | Total amount of administered propofol. |
| Diaphragma movement | Duration of surgery (an average of 2 hours) | Diaphragma movement is measured by ultrasound. |
| NIRS (near-infrared spectrometry) | Duration of surgery (an average of 2 hours) | Near-infrared spectrometry in % of left and right hemisphere |
| heart rate | Duration of surgery (an average of 2 hours) | by ECG. |
| blood pressure | Duration of surgery (an average of 2 hours) | NIBP and IBP. |
| TTE (transthoracic echocardiography) | shortly before DISE (an average of 30 minutes) | Parameters of left and right ventricular function, as well as function of heart valves before DISE. |
| EEG parameters | Duration of surgery (an average of 2 hours) | Parameters measured by the Sedline monitor |
| blood gases | Duration of surgery (an average of 2 hours) | Arterial blood gas is obtained from an arterial line. |
Countries
Germany
Outcome results
None listed