SurgeryNCT04062240
Bispectral Index: A Comparison of Bifrontal Montage Agreement
An observational study of Surgery and Bispectral Index, run by Mayo Clinic at 1 site in United States.
Trial summary
The researchers are trying to compare the results of two sensors when recorded simultaneously on opposite sides of the forehead. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Bispectral Index
- What is being tested?
- BIS sensor
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Nov 2019to 1 Oct 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population consists of adult patients undergoing elective cardiac surgery, for whom BIS monitoring will be used.
Who may be able to join
- 1. Adult patient having elective cardiac surgery
Who cannot join
- Patient refusal.
- Pediatric patients.
- Emergency procedure.
- Patients with known or suspected carotid or cerebrovascular disease.
- Patients with prior stroke.
- Skin condition or anatomy preventing proper sensor placement.
Trial locations and contacts
1 site in 1 country.
About this study
The researchers are trying to compare the results of two sensors when recorded simultaneously on opposite sides of the forehead.
Read the 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.
- Conditions
- Surgery, Bispectral Index
- Being tested
- BIS sensor
- Keywords
- BIS, Bispectral Index, Paralysis
- Medical subject headings
- Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS sensorDevice
BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: BIS sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 minutes where both sensors are recording concurrently
Secondary outcomes (1)
Ketamine
Degree to which Ketamine may influence BIS values
Measured: 10 minutes where both sensors are recording concurrently
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2019
- Study start27 Nov 2019
- Primary completion1 Jun 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew J. Ritter, Mayo Clinic
- Investigators
- Matthew Ritter, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04062240
- Sponsor's protocol ID
- 19-000568
- Status last verified
- May 2022
- First submitted
- 16 Aug 2019
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 12873942Schuller 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.
PubMed 26174308Vivien 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.
PubMed 12826836
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bispectral Index: A Comparison of Bifrontal Montage Agreement
- ClinicalTrials.gov ID
- NCT04062240
- Acronym / sponsor ID
- 19-000568
- Conditions
- Surgery, Bispectral Index
- Keywords
- BIS, Bispectral Index, Paralysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 27 Nov 2019 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 20 Aug 2019 (actual)
- Results
- Posted 21 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Additional BIS sensor | – | Device: BIS sensorMany 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of adult patients undergoing elective cardiac surgery, for whom BIS monitoring will be used.
Key inclusion criteria (1 listed)
- 1. Adult patient having elective cardiac surgery
Key exclusion criteria (6 listed)
- Patient refusal.
- Pediatric patients.
- Emergency procedure.
- Patients with known or suspected carotid or cerebrovascular disease.
- Patients with prior stroke.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BIS sensorBIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed . | Device | Additional BIS sensor |
Primary outcome
BIS Montage
Time frame: 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.
1 secondary outcome
Ketamine
Time frame: 10 minutes where both sensors are recording concurrently
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12873942Messner 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.
- Results publication: PubMed 26174308Schuller 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.
- Results publication: PubMed 12826836Vivien 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Ritter, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Bispectral Index, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BIS Montage (time frame: 10 minutes where both sensors are recording concurrently). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04062240, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.