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

Completed

• Conditions: Echocardiography; Electroencephalography; Blood Gas Monitoring, Transcutaneous; Consciousness Monitors; Sleep Apnea, Obstructive
• Interventions: Device: PSI

• Registration Number: NCT03224936
• Lead Sponsor: Charite University, Berlin, Germany

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.

Study Timeline

• Study First Submitted: 2017-07-19
• Study First Submitted QC: 2017-07-19
• Study First Posted: 2017-07-21
• Study Start: 2017-08-22
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
transcutaneous O2 (oxygen)	Duration of surgery (an average of 2 hours)	Measured at the center of the chest.
NIRS (near-infrared spectrometry)	Duration of surgery (an average of 2 hours)	Near-infrared spectrometry in % of left and right hemisphere
blood gases	Duration of surgery (an average of 2 hours)	Arterial blood gas is obtained from an arterial line.
Propofol	Duration of surgery (an average of 2 hours)	Total amount of administered propofol.
transcutaneous CO2 (carbon dioxide)	Duration of surgery (an average of 2 hours)	Measured at the chest.
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.
Diaphragma movement	Duration of surgery (an average of 2 hours)	Diaphragma movement is measured by ultrasound.
EEG parameters	Duration of surgery (an average of 2 hours)	Parameters measured by the Sedline monitor

Trial Locations

Locations (1)

Charité - Universitätsmedizin Berlin Campus Charité Mitte; 🇩🇪 Berlin, Germany