Bispectral Index, Surgery
Conditions
Keywords
BIS, Bispectral Index, Paralysis
Brief summary
The researchers are trying to compare the results of two sensors when recorded simultaneously on opposite sides of the forehead.
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.
Interventions
DEVICEBIS sensor
BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .
Sponsors
Mayo Clinic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BIS Montage | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ketamine | 10 minutes where both sensors are recording concurrently | Degree to which Ketamine may influence BIS values |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
BIS sensor: BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed . | 15 |
| Total | 15 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | equipment malfunction | 1 |
Baseline characteristics
| Characteristic | Additional BIS Sensor | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 5 Participants | — |
| Age, Categorical Between 18 and 65 years | 10 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
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.
Time frame: 10 minutes where both sensors are recording concurrently
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Additional BIS Sensor | BIS Montage | 0.01 units on a scale |
Secondary
Ketamine
Degree to which Ketamine may influence BIS values
Time frame: 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.