The Alternative Position for the SedLine® Sensor

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

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.

Study Overview

• Status: Completed
• Conditions: Depth of Anesthesia Monitoring

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 Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United Arab Emirates
  • Abu Dhabi, United Arab Emirates
    • Cleveland Clinic Abu Dhabi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

For each of the two modes of measurement, 1800 data points per subject (1 reading every 2 seconds for 1 hour) per hour will be collected. Assuming a maximum interclass correlation coefficient of .90, a sample size of 40 patients will be required to test the null hypotheses that the two modes of measurement share 95% of their variance via the construction of a 95% confidence interval that ranges no more than +/-5%.

Data from the 2 placements will be compared and analyzed using a Bland-Altman analysis, a Scatter plot analysis, and a matched-pair analysis.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of nasal SedLine® EEG sensor position for monitoring the depth of anesthesia using processed electroencephalograph values	Determine whether it is possible to apply an alternative SedLine® EEG sensor position in a situation where a standard-forehead position is not possible.	One year

Collaborators and Investigators

• Sponsor: Cleveland Clinic Abu Dhabi
• Collaborators: Masimo Corporation
• Investigators: Principal Investigator: Boris Tufegdzic, MD, Cleveland Clinic Abu Dhabi

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: May 7, 2019
• First Submitted That Met QC Criteria: May 8, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): July 15, 2020
• Last Update Submitted That Met QC Criteria: July 14, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Depth of anesthesia; SedLine® sensor; Alternative position
• Other Study ID Numbers: A-2019-028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No