The Alternative Position for the SedLine® Sensor

NCT ID: NCT03947060

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2020-04-01

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.

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).

Conditions

Depth of Anesthesia Monitoring

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masimo Corporation

INDUSTRY

Sponsor Role: collaborator

Cleveland Clinic Abu Dhabi

OTHER

Sponsor Role: lead

Responsible Party

Boris Tufegdzic

Asst Prof Dr Boris Tufegdzic

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Boris Tufegdzic, MD

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic Abu Dhabi

Locations

Cleveland Clinic Abu Dhabi

Abu Dhabi, , United Arab Emirates

Countries

United Arab Emirates

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

A-2019-028

Identifier Type: -

Identifier Source: org_study_id