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NCT03052543 · ClinicalTrials.gov registry record
Outcomes of an Intraoperative Bispectral Index Monitor
A clinical trial, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- 60
- Enrollment target
NCT03052543: Completed study, sponsored by Boston Children's Hospital.
NCT03052543 is a clinical trial that has completed, run by Boston Children's Hospital. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03052543 has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- 60 participants
- Enrollment target
Study 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. 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.
Primary Outcome
Compare the BIS values in the BISblind and BISvisible groups
Interventions
- DEVICE BIS™ Complete 2--Channel Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2018-03-07 |
| Est. Completion | 2019-10-11 |
What the finished NCT03052543 record still lists
NCT03052543 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which BIS™ Complete 2--Channel Monitor is the first listed.
NCT03052543 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03052543 about?
NCT03052543 is a clinical study titled "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 wav...
What is the current status of trial NCT03052543?
This trial is currently completed. The enrollment target is 60 participants. The study started on 2018-03-07. Estimated completion is 2019-10-11.
What interventions are being tested in trial NCT03052543?
The interventions under investigation include: BIS™ Complete 2--Channel Monitor (DEVICE).
Who is sponsoring clinical trial NCT03052543?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
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