Trial Outcomes & Findings for Bispectral Index: A Comparison of Bifrontal Montage Agreement (NCT NCT04062240)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

15 participants

Primary outcome timeframe

10 minutes where both sensors are recording concurrently

Results posted on

2023-02-21

Participant Flow

Participant milestones

Participant milestones
Measure	Additional Bispectral Index (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. BIS sensor: BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .
Overall Study STARTED	15
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Additional Bispectral Index (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. BIS sensor: BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .
Overall Study equipment malfunction	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Additional BIS Sensor n=15 Participants 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. BIS sensor: BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=15 Participants
Age, Categorical >=65 years	5 Participants n=15 Participants
Sex: Female, Male Female	10 Participants n=15 Participants
Sex: Female, Male Male	5 Participants n=15 Participants

PRIMARY outcome

Timeframe: 10 minutes where both sensors are recording concurrently

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.

Outcome measures

Outcome measures
Measure	Additional BIS Sensor n=14 Participants 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. BIS sensor: BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .
BIS Montage	0.01 units on a scale Interval -8.01 to 8.03

SECONDARY outcome

Timeframe: 10 minutes where both sensors are recording concurrently

Population: Due to the inconsistent usage and dosages of ketamine administered to the study population, no data was collected to examine this secondary measure.

Degree to which Ketamine may influence BIS values

Outcome measures

Outcome data not reported

Adverse Events

Additional BIS Sensor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Matthew Ritter

Mayo Clinic

Phone: 507-255-5123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place