AnesthesiaNCT03052543
Outcomes of an Intraoperative Bispectral Index Monitor
An observational study of Anesthesia, run by Boston Children's Hospital at 1 site in United States.
Trial summary
This pilot study is being conducted to determine whether the intraoperative presence of a Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. Read more about this study
- Who is it for?
- Ages 2 to 12 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- BIS™ Complete 2--Channel Monitor
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2018to 11 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 2 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: 60 patients ages 2-12 scheduled for day surgery at Boston Children's Hospital
Who may be able to join
- orthopedic or urologic day surgery
- 2 to 12 years old
Who cannot join
- anesthesiologist refusal
- patient/parent refusal
- allergy to the BIS adhesive
- history of seizures
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston Children's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Pilot Study to Determine the Outcomes of an Intraoperative Bispectral Index Monitor
This pilot study is being conducted to determine whether the intraoperative presence of a Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in adult and pediatric studies it has been shown to decrease time to emergence, decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters, when BIS is present but not specifically designated to be used as a monitor to guide anesthesia delivery, has not been specifically examined. This will be the first pediatric study which applies BIS on all patients and randomizes the anesthesiologists to either be or not be privy to seeing the BIS values during intra-operative period.
Read the detailed description
The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. In adult and pediatric studies, the BIS monitor has been shown to decrease time to emergence, decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters, when BIS is present but not specifically designated to be used as a monitor to guide anesthesia delivery, has not been specifically examined. This will be the first pediatric study which applies BIS on all patients and randomizes the anesthesiologists to either be or not be privy to seeing the BIS values during intra-operative period.
- Conditions
- Anesthesia
- Being tested
- BIS™ Complete 2--Channel Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIS™ Complete 2--Channel MonitorDevice
monitor depth of anesthesia
| Study group | Role | What they receive |
|---|---|---|
| BISblind | The BISblind group will have the BIS monitor and data physically hidden from the anesthesiologist. The patient will receive an anesthetic as per the anesthesiologist's particular care plan, unaltered by the study. Receives: Device: BIS™ Complete 2--Channel Monitor | |
| BISvisible | BISvisible group will have the BIS monitor and data available for the anesthesiologist to view. The patient will receive an anesthetic as per the anesthesiologist's particular care plan, unaltered by the study. Receives: Device: BIS™ Complete 2--Channel Monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
BIS values
Compare the BIS values in the BISblind and BISvisible groups
Measured: intraoperative period
Secondary outcomes (5)
Amount of intravenous anesthetic medications administered
Compare the amount of intravenous anesthetic medications administered between the BISblind and BISvisible groups
Measured: intraoperative period
End tidal sevoflurane values
Compare the end tidal sevoflurane values between the BISblind and BISvisible groups
Measured: intraoperative period
Agitation/delirium
Determine the incidence of agitation and delirium using the post-anesthesia emergence delirium scale in the post anesthesia care unit
Measured: post operative period, until discharge from recovery room, assessed up to 10 hours
Pain scores
Compare the pain scores between the BISblind and BISvisible groups
Measured: post operative period, until discharge from recovery room, assessed up to 10 hours
Time to meet discharge criteria
Compare the time needed to meet discharge criteria between the BISblind and BISvisible groups
Measured: post operative period, until discharge from recovery room, assessed up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start7 Mar 2018
- Primary completion11 Oct 2019
- Study completion11 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keira Mason, Boston Children's Hospital
- Investigators
- Keira Mason, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052543
- Sponsor's protocol ID
- IRB-P00024412
- Status last verified
- Oct 2020
- First submitted
- 3 Jan 2017
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Outcomes of an Intraoperative Bispectral Index Monitor
- ClinicalTrials.gov ID
- NCT03052543
- Acronym / sponsor ID
- IRB-P00024412
- Conditions
- Anesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 7 Mar 2018 (actual)
- Primary completion
- 11 Oct 2019 (actual)
- Study completion
- 11 Oct 2019 (actual)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is being conducted to determine whether the intraoperative presence of a Bispectral Index Monitor (BIS), a non-invasive monitor, affects the perioperative and postoperative indices and outcomes. The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. This monitor is not a Standard of Care Monitor, yet in adult and pediatric studies it has been shown to decrease time to emergence, decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters, when BIS is present but not specifically designated to be used as a monitor to guide anesthesia delivery, has not been specifically examined. This will be the first pediatric study which applies BIS on all patients and randomizes the anesthesiologists to either be or not be privy to seeing the BIS values during intra-operative period.
Detailed description
The BIS monitor is an adhesive sensor that is applied to the forehead to monitor EEG waves. In adult and pediatric studies, the BIS monitor has been shown to decrease time to emergence, decrease volatile anesthesia requirement, decrease recovery time and in some cases, decrease post-operative morbidity (REFS). The effect on intra-operative and post-operative parameters, when BIS is present but not specifically designated to be used as a monitor to guide anesthesia delivery, has not been specifically examined. This will be the first pediatric study which applies BIS on all patients and randomizes the anesthesiologists to either be or not be privy to seeing the BIS values during intra-operative period.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BISblind | – | Device: BIS™ Complete 2--Channel MonitorThe BISblind group will have the BIS monitor and data physically hidden from the anesthesiologist. The patient will receive an anesthetic as per the anesthesiologist's particular care plan, unaltered by the study. |
| BISvisible | – | Device: BIS™ Complete 2--Channel MonitorBISvisible group will have the BIS monitor and data available for the anesthesiologist to view. The patient will receive an anesthetic as per the anesthesiologist's particular care plan, unaltered by the study. |
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 60 patients ages 2-12 scheduled for day surgery at Boston Children's Hospital
Key inclusion criteria (2 listed)
- orthopedic or urologic day surgery
- 2 to 12 years old
Key exclusion criteria (4 listed)
- anesthesiologist refusal
- patient/parent refusal
- allergy to the BIS adhesive
- history of seizures
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™ Complete 2--Channel Monitormonitor depth of anesthesia | Device | BISblind, BISvisible |
Primary outcome
BIS values
Time frame: intraoperative period
Compare the BIS values in the BISblind and BISvisible groups
5 secondary outcomes
Amount of intravenous anesthetic medications administered
Time frame: intraoperative period
End tidal sevoflurane values
Time frame: intraoperative period
Agitation/delirium
Time frame: post operative period, until discharge from recovery room, assessed up to 10 hours
Pain scores
Time frame: post operative period, until discharge from recovery room, assessed up to 10 hours
Time to meet discharge criteria
Time frame: post operative period, until discharge from recovery room, assessed up to 10 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2020.
- 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.
Keira Mason, MD principal investigator
Boston Children's Hospital
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 Anesthesia, run by Boston Children's Hospital 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 2 inclusion and 4 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 14 Oct 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 values (time frame: intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.