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

Sleep Apnea, Obstructive Clinical Trial

Official 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03224936
• Other study ID #: Propofolschlaf
• Status: Active, not recruiting
• Start date: August 22, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: July 2019
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 31, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Germany	Charité - Universitätsmedizin Berlin Campus Charité Mitte	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	NIRS (near-infrared spectrometry)	Near-infrared spectrometry in % of left and right hemisphere	Duration of surgery (an average of 2 hours)
Secondary	transcutaneous CO2 (carbon dioxide)	Measured at the chest.	Duration of surgery (an average of 2 hours)
Secondary	transcutaneous O2 (oxygen)	Measured at the center of the chest.	Duration of surgery (an average of 2 hours)
Secondary	Propofol	Total amount of administered propofol.	Duration of surgery (an average of 2 hours)
Secondary	Diaphragma movement	Diaphragma movement is measured by ultrasound.	Duration of surgery (an average of 2 hours)
Secondary	blood gases	Arterial blood gas is obtained from an arterial line.	Duration of surgery (an average of 2 hours)
Secondary	heart rate	by ECG.	Duration of surgery (an average of 2 hours)
Secondary	blood pressure	NIBP and IBP.	Duration of surgery (an average of 2 hours)
Secondary	TTE (transthoracic echocardiography)	Parameters of left and right ventricular function, as well as function of heart valves before DISE.	shortly before DISE (an average of 30 minutes)
Secondary	EEG parameters	Parameters measured by the Sedline monitor	Duration of surgery (an average of 2 hours)