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

Charité University Medicine Berlin

Status: Completed

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

Treatments: Device: PSI

Study type: Observational

Funder types: Other

Identifiers

NCT03224936

Propofolschlaf

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

DISE group

Description:

All patients in this study group will receive a propofol PSI controlled DISE (drug induced sleep endoscopy).

Treatment:

Device: PSI