The Alternative Position for the SedLine® Sensor

NCT03947060 | Completed

• 1 other identifier: A-2019-028
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Depth of Anesthesia Monitoring

Keywords

Depth of anesthesia; SedLine® sensor; Alternative position

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cleveland Clinic Abu Dhabi: lead
• Masimo Corporation: collaborator

Study Sites (1)

Cleveland Clinic Abu Dhabi

Abu Dhabi, United Arab Emirates

Location

Study Officials

• Boris Tufegdzic, MD

  Cleveland Clinic Abu Dhabi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Prof Dr Boris Tufegdzic

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 13, 2019
• Study Start: December 1, 2019
• Primary Completion: February 29, 2020
• Study Completion: April 1, 2020
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

AE (1)