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

NCT ID: NCT03224936

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-22
• Study Completion Date: 2019-12-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DISE group

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

PSI

Intervention Type: DEVICE

The PSI delivered by Masimo Root (Sedline) will be measured in all patients.

Interventions

PSI

The PSI delivered by Masimo Root (Sedline) will be measured in all patients.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Sascha Treskatsch

Deputy head of department Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sascha Treskatsch, MD, Prof

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, State of Berlin, Germany

Countries

Germany

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Other Identifiers

Propofolschlaf

Identifier Type: -

Identifier Source: org_study_id