The Alternative Position for the SedLine® Sensor

Depth of Anesthesia Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03947060
• Other study ID #: A-2019-028
• Status: Completed
• Start date: December 1, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: July 2020
• Source: Cleveland Clinic Abu Dhabi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 1, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depth of Anesthesia Monitoring

Locations

Country	Name	City	State
United Arab Emirates	Cleveland Clinic Abu Dhabi	Abu Dhabi

Sponsors (2)

Lead Sponsor	Collaborator
Cleveland Clinic Abu Dhabi	Masimo Corporation

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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