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

NCT03224936 | Completed

• 1 other identifier: Propofolschlaf
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

DISE; OSAS; PSI

Outcome Measures

Primary Outcomes (1)

• PSI

  Depth of sedation is monitored with a SEDline electroencephalograph based monitor that displays patient state index (PSI).

  Duration of surgery (an average of 2 hours)

Secondary Outcomes (10)

• NIRS (near-infrared spectrometry)

  Duration of surgery (an average of 2 hours)

• transcutaneous CO2 (carbon dioxide)

  Duration of surgery (an average of 2 hours)

• transcutaneous O2 (oxygen)

  Duration of surgery (an average of 2 hours)

• Propofol

  Duration of surgery (an average of 2 hours)

• Diaphragma movement

  Duration of surgery (an average of 2 hours)

Study Arms (1)

DISE group

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

Device: PSI

Interventions

PSI DEVICE

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

DISE group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

18 years or older voluntary patients with an obstructive sleep apnea syndrome undergoing elective propofol induced sleep endoscopy at Charité - Universitätsmedizin Berlin Campus Charite Mitte.

You may qualify if:

• 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

You may not qualify if:

• 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
• % or more central or mixed apneas in polysomnography

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, State of Berlin, 10115, Germany

Location

Related Publications (29)

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MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Sascha Treskatsch, MD, Prof

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy head of department Department of Anesthesiology and Operative Intensive Care Medicine, CCM and CVK

Study Record Dates

• First Submitted: July 19, 2017
• First Posted: July 21, 2017
• Study Start: August 22, 2017
• Primary Completion: October 30, 2019
• Study Completion: December 31, 2019
• Last Updated: February 14, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)