The Alternative Position for the SedLine® Sensor

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Depth of Anesthesia Monitoring

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nasal & Frontal sensor position<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depth of anesthesia, SedLine® sensor, Alternative position