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Completed

NCT Number: NCT03224936

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Charité - Universitätsmedizin Berlin Campus Charité Mitte

Berlin, State of Berlin, 10115, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSI

Device

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

Primary outcomes

  1. PSI

    Time frame: 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 outcomes

  1. NIRS (near-infrared spectrometry)

    Time frame: Duration of surgery (an average of 2 hours)

    Near-infrared spectrometry in % of left and right hemisphere

  2. transcutaneous CO2 (carbon dioxide)

    Time frame: Duration of surgery (an average of 2 hours)

    Measured at the chest.

  3. transcutaneous O2 (oxygen)

    Time frame: Duration of surgery (an average of 2 hours)

    Measured at the center of the chest.

  4. Propofol

    Time frame: Duration of surgery (an average of 2 hours)

    Total amount of administered propofol.

  5. Diaphragma movement

    Time frame: Duration of surgery (an average of 2 hours)

    Diaphragma movement is measured by ultrasound.

  6. blood gases

    Time frame: Duration of surgery (an average of 2 hours)

    Arterial blood gas is obtained from an arterial line.

  7. heart rate

    Time frame: Duration of surgery (an average of 2 hours)

    by ECG.

  8. blood pressure

    Time frame: Duration of surgery (an average of 2 hours)

    NIBP and IBP.

  9. TTE (transthoracic echocardiography)

    Time frame: shortly before DISE (an average of 30 minutes)

    Parameters of left and right ventricular function, as well as function of heart valves before DISE.

  10. EEG parameters

    Time frame: Duration of surgery (an average of 2 hours)

    Parameters measured by the Sedline monitor

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jul 21, 2017
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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