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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03224936
Date of registration:	19/07/2017
Prospective Registration:	Yes
Primary sponsor:	Charite University, Berlin, Germany
Public title:	Propofolsleep - A Study on Cardiopulmonary and Pharyngeal Reactions While Drug Induced Sleep Endoscopy (DISE)
Scientific 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
Date of first enrolment:	August 22, 2017
Target sample size:	20
Recruitment status:	Active, not recruiting
URL:	https://clinicaltrials.gov/show/NCT03224936
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Germany

Contacts

Name:	Sascha Treskatsch, MD, Prof
Address:
Telephone:
Email:
Affiliation:	Charite University, Berlin, Germany

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Consciousness Monitors

Blood Gas Monitoring, Transcutaneous

Echocardiography

Electroencephalography

Sleep Apnea, Obstructive

Intervention(s)

Device: PSI

Primary Outcome(s)

PSI [Time Frame: Duration of surgery (an average of 2 hours)]

Secondary Outcome(s)

transcutaneous CO2 (carbon dioxide) [Time Frame: Duration of surgery (an average of 2 hours)]

blood gases [Time Frame: Duration of surgery (an average of 2 hours)]

TTE (transthoracic echocardiography) [Time Frame: shortly before DISE (an average of 30 minutes)]

transcutaneous O2 (oxygen) [Time Frame: Duration of surgery (an average of 2 hours)]

NIRS (near-infrared spectrometry) [Time Frame: Duration of surgery (an average of 2 hours)]

blood pressure [Time Frame: Duration of surgery (an average of 2 hours)]

Diaphragma movement [Time Frame: Duration of surgery (an average of 2 hours)]

Propofol [Time Frame: Duration of surgery (an average of 2 hours)]

EEG parameters [Time Frame: Duration of surgery (an average of 2 hours)]

heart rate [Time Frame: Duration of surgery (an average of 2 hours)]

Secondary ID(s)

Propofolschlaf

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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