Bispectral Index: A Comparison of Bifrontal Montage Agreement

The researchers are trying to compare the results of two sensors when recorded simultaneously on opposite sides of the forehead.

Study Overview

• Status: Completed
• Conditions: Surgery; Bispectral Index
• Intervention / Treatment: Device: BIS sensor

Detailed Description

Bispectral Index (BIS) monitors are FDA approved to gauge depth of sedation by analyzing segments of electroencephalogram (EEG) waves. The BIS monitor utilizes a proprietary algorithm to process the EEG information second by second, and outputs a number (0-100) that corresponds with a patient's level of consciousness. A level of 0 indicates no EEG activity; a level of 100 indicates awake EEG activity. Several studies demonstrated that BIS monitors may not be useful in paralyzed patients, as patients who were paralyzed and not sedated unexpectedly showed a large decrease in their BIS values following administration paralytic medications. Vivien et al found BIS values dropped an average of 24 points in already sedated patients when the patients were given paralytics. In the same year, Messner and colleagues paralyzed non-sedated volunteers and found a dramatic drop in BIS values until paralysis wore off or was reversed. Schuller et al repeated the Messner experiment and found similar results with 18 of 20 non-sedated volunteer's BIS values dropping to levels expected of patients who were sedated. These results suggest that BIS monitors are integrating electromyography (EMG) data into its algorithm to derive a BIS value. Our hypothesis is that a BIS monitor commenced after paralysis, thereby lacking exposure to any "awake" EMG activity, will result in a cleaner data set and more accurate representation of a patient's level of sedation. Studying in this manner will require the subject to wear two BIS sensors in a frontal montage. The manufacturer of the sensors gives no guidance as to which side of the forehead an individual sensor is placed, and no studies demonstrate BIS validity with the use of concurrent sensors. The purpose of the present investigation is to assess the measurement difference and variability associated with use of concurrent bifrontal BIS sensors. The data obtained will be used as a framework for a future study related to the use of paralytics and BIS monitoring.

• Study Type: Observational
• Enrollment (Actual): 15

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients undergoing elective cardiac surgery, for whom BIS monitoring will be used.

Description

Inclusion Criteria:

1. Adult patient having elective cardiac surgery

Exclusion Criteria:

1. Patient refusal.
2. Pediatric patients.
3. Emergency procedure.
4. Patients with known or suspected carotid or cerebrovascular disease.
5. Patients with prior stroke.
6. Skin condition or anatomy preventing proper sensor placement.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Additional BIS sensor; Many providers caring for cardiovascular surgical patients utilizes BIS monitoring to gauge depth of anesthesia. The current practice involves placement of the BIS sensor on the patient's forehead per the manufacturer's recommendation on arrival to the operating room. The intervention in this study will add an additional BIS sensor to the patient's forehead. After syncing the two monitors for time, and ensuring appropriate skin contact and signal quality of both sensors, BIS monitoring will commence. BIS readings will be available every 12 seconds during the duration of the study, yielding up to 240 points of comparison per enrolled patient.

Device: BIS sensor; BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS Montage	Degree of variability between the values produced by the BIS sensors in a bifrontal montage when monitored simultaneously by use of a Bland-Altmann plot. The average value of each timed pair was plotted against the difference between the pairs. The BIS monitor outputs data on a scale of 0-100 in arbitrary units; 0 = an isoelectric state on EEG, 100 = fully awake patient. BIS values of 40-60 are thought to reduce the chance of patient recall during general anesthesia. For the purpose of this study, a smaller confidence interval is better as it indicates a higher level of agreement between the two BIS sensors.	10 minutes where both sensors are recording concurrently

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ketamine	Degree to which Ketamine may influence BIS values	10 minutes where both sensors are recording concurrently

Collaborators and Investigators

• Sponsor: Mayo Clinic

Publications and helpful links

General Publications

• Messner M, Beese U, Romstock J, Dinkel M, Tschaikowsky K. The bispectral index declines during neuromuscular block in fully awake persons. Anesth Analg. 2003 Aug;97(2):488-491. doi: 10.1213/01.ANE.0000072741.78244.C0.
• Schuller PJ, Newell S, Strickland PA, Barry JJ. Response of bispectral index to neuromuscular block in awake volunteers. Br J Anaesth. 2015 Jul;115 Suppl 1:i95-i103. doi: 10.1093/bja/aev072.
• Vivien B, Di Maria S, Ouattara A, Langeron O, Coriat P, Riou B. Overestimation of Bispectral Index in sedated intensive care unit patients revealed by administration of muscle relaxant. Anesthesiology. 2003 Jul;99(1):9-17. doi: 10.1097/00000542-200307000-00006.

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2019
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): October 1, 2021

Study Registration Dates

• First Submitted: August 16, 2019
• First Submitted That Met QC Criteria: August 16, 2019
• First Posted (Actual): August 20, 2019

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Paralysis; BIS; Bispectral Index
• Other Study ID Numbers: 19-000568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes