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The Alternative Position for the SedLine® Sensor

Sponsor
Cleveland Clinic Abu Dhabi (Other)
Overall Status
Completed
CT.gov ID
NCT03947060
Collaborator
Masimo Corporation (Industry)
40
Enrollment
1
Location
4
Actual Duration (Months)
10
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

SedLine® Brain Function Monitoring provides real-time insight into a patient's depth of anesthesia with bilateral data acquisition and processing of electroencephalogram (EEG) signals. Four active EEG leads collect data from the frontal lobe with a sensor position on the patient's forehead.

Whenever a frontal approach for neurosurgical procedures is required or the frontal placement of the EEG is not indicated, it would not be possible to place the SedLine® .

Numerous studies have analyzed the change of position and the application of alternative positions for other devices used in assessing the depth of anesthesia. Albeit, yet to date, there is no study that analyzed the application of alternative positions for the SedLine® sensor.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The purpose of study is to compare the standard forehead placement versus a nasal placement of SedLine® sensor for neuromonitoring.

    The hypothesis is that placing the central sensors in the montage approximately 2 cm below the standard recommended placement, across the nasal bridge and then running under the eyes to the normal temporal leads placement would put the entire montage out of the operative field and would still have corresponding values and EEG signals.

    The primary outcome measure is to monitor and compare processed electroencephalograph (EEG) values (PSi- Patient State Index, SEFL- Spectral Edge Frequency Left, SEFR- Spectral Edge Frequency Right, SR-Suppression Ratio, EMG-Electromyography, ARTF-Artifact) and EEG waveforms, on both sensors (standard-Forehead and alternative-Nasal)

    Other parameters that will be measure are patient demographics (age, sex, surgery, ASA status, weight, height, BMI).

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    BI-SENSES: Validation of Nasal Versus Frontal Placement of the SedLine® Sensor Through Processed Electroencephalography in Adult Patients Undergoing General Anesthesia
    Actual Study Start Date :
    Dec 1, 2019
    Actual Primary Completion Date :
    Feb 29, 2020
    Actual Study Completion Date :
    Apr 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Nasal & Frontal sensor position

    One group of participants with two modes of measurement. First mode is standard frontal placement of the SedLine® sensor. Second mode is alternative nasal placement of the SedLine® sensor.

    Outcome Measures

    Primary Outcome Measures

    1. Validation of nasal SedLine® EEG sensor position for monitoring the depth of anesthesia using processed electroencephalograph values [One year]

      Determine whether it is possible to apply an alternative SedLine® EEG sensor position in a situation where a standard-forehead position is not possible.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients older than 18 years of age, both genders.

    • Patients undergoing simple or complex surgery.

    • American Society of Anesthesiologists Classification (ASA) score I to III.

    Exclusion Criteria:

    American Society of Anesthesiologists Classification (ASA) score IV and V.

    • Emergency cases

    • Cognitive/Mentally impaired or unable to provide consent

    • Previous neurological problems affecting EEG

    • Dementia

    • Use of sedative or drugs that can alter EEG readings

    • Patients under head and neck surgery

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Cleveland Clinic Abu Dhabi Abu Dhabi United Arab Emirates

    Sponsors and Collaborators

    • Cleveland Clinic Abu Dhabi
    • Masimo Corporation

    Investigators

    • Principal Investigator: Boris Tufegdzic, MD, Cleveland Clinic Abu Dhabi

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Boris Tufegdzic, Asst Prof Dr Boris Tufegdzic, Cleveland Clinic Abu Dhabi
    ClinicalTrials.gov Identifier:
    NCT03947060
    Other Study ID Numbers:
    • A-2019-028
    First Posted:
    May 13, 2019
    Last Update Posted:
    Jul 15, 2020
    Last Verified:
    Jul 1, 2020
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Boris Tufegdzic, Asst Prof Dr Boris Tufegdzic, Cleveland Clinic Abu Dhabi
    Depth of anesthesia
    SedLine® sensor
    Alternative position

    Study Results

    No Results Posted as of Jul 15, 2020