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OpenTrials
Completed

NCT Number: NCT03947060

The Alternative Position for the SedLine® Sensor

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.

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Key information

Conditions

Depth of Anesthesia Monitoring

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Cleveland Clinic Abu Dhabi

Other

Collaborators

  • Masimo Corporation

Registry information

Official study title

BI-SENSES: Validation of Nasal Versus Frontal Placement of the SedLine® Sensor Through Processed Electroencephalography in Adult Patients Undergoing General Anesthesia

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 13, 2019
Registry last updated
Jul 15, 2020

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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