Bispectral Monitoring for Sedation
(BIMV Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if Bispectral index (BIS) monitors can affect the duration of mechanical ventilation, ICU stay, and sedation medication requirements. BIS monitors track brain activity to ensure optimal sedation levels. The study compares two groups: one with BIS monitoring and one without. Suitable candidates for this trial include individuals admitted to the medical ICU, currently on a ventilator, and receiving sedation medication. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance ICU care for future patients.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop your current medications, but it does exclude patients on certain medications like neuromuscular blockade or benzodiazepine infusions. It's best to discuss your specific medications with the trial team.
What prior data suggests that Bispectral Monitoring is safe for sedation?
Research has shown that Bispectral Index (BIS) monitoring is commonly used in anesthesiology to measure sedation depth. This system checks brain activity to assess the effects of sedation. Studies indicate that BIS monitoring is a standard method for evaluating sedation levels without disturbing patients. It ensures the sedation remains at the correct level, which is crucial for individuals who are chemically paralyzed during procedures.
Sources mention no specific safety concerns, suggesting that BIS monitoring is generally well-tolerated. It is important to note that BIS monitoring is not a drug or invasive treatment but a tool for guiding sedation. This makes it less likely to cause side effects compared to medications. Overall, current research supports BIS monitoring as a safe and effective method for managing sedation.12345Why are researchers excited about this trial?
Researchers are excited about Bispectral Monitoring for sedation because it offers a more precise way to monitor brain activity during sedation compared to traditional methods like clinical observation or basic monitoring tools. Unlike standard sedation assessment which can be subjective and less accurate, Bispectral Monitoring provides real-time, objective data on the patient's level of consciousness. This could lead to more tailored sedation, reducing the risk of over or under-sedation, and potentially improving patient safety and outcomes.
What evidence suggests that Bispectral Monitoring is effective for sedation?
This trial will compare Bispectral Index (BIS) monitoring with a non-BIS approach for managing sedation. Research has shown that BIS monitoring effectively tracks sedation depth. Studies have found that BIS monitoring can reduce the amount of sedative medicine needed, which are drugs that induce sleepiness or relaxation. This reduction can also shorten the time patients require breathing machines. BIS scores closely match other methods of measuring sedation levels in intensive care units. However, BIS may not accurately detect very deep sedation. Overall, BIS monitoring is considered a safe and useful tool for managing sedation levels in clinical settings.46789
Who Is on the Research Team?
Pascal L Kingah, MD, MPH
Principal Investigator
The University of Texas Health Science Center, Houston
Are You a Good Fit for This Trial?
This trial is for patients who require sedation while on mechanical ventilation in the ICU. Specific eligibility criteria are not provided, so it's important to contact the study team for detailed inclusion and exclusion criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are monitored using Bispectral index monitoring (BIS) or not while on mechanical ventilation
ICU Stay
Participants' ICU length of stay is evaluated
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Bispectral Monitoring
Trial Overview
The study aims to compare two groups of ventilated patients: one monitored with Bispectral index (BIS) monitors and another without BIS monitoring. It will assess differences in ventilation duration, ICU stay length, and total sedative medication doses.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
The University of Texas Health Science Center, Houston
Lead Sponsor
Citations
Effectiveness Assessment of Bispectral Index Monitoring ...
The purpose of this meta-analysis and systematic review was to assess the effectiveness of BIS for depth of anesthesia monitoring.
Assessment of depth of sedation using Bispectral Index™ ...
This study supports previous work showing that BIS decreases with decreasing sedation score. However, the variation in BIS values increased with deeper levels ...
Clinical and economic value of bispectral index monitoring ...
In clinical practice, BIS monitoring appears to be a safe and effective method for avoiding excessive consumption of sedatives and providing ...
4.
researchrepository.parkviewhealth.org
researchrepository.parkviewhealth.org/cgi/viewcontent.cgi?article=1068&context=pharmaSystematic review and meta-analysis of the correlation ...
Conclusions: BIS demonstrated moderate to strong correlation with clinical sedation scales in adult ICU patients, providing preliminary evidence ...
Bispectral Index Monitoring of Conscious Sedation With the ...
Conclusions: BIS has a low accuracy for detecting deep sedation as a result of a considerable overlap of scores across the sedation levels.
Bispectral Index - StatPearls - NCBI Bookshelf - NIH
The BIS monitoring system is used in anesthesiology to assess the depth of anesthesia. It relies on power concentration in the 40 to 47 Hz frequency range.
7.
vumc.org
vumc.org/cvicu/sites/default/files/2020-02/BIS-brain-monitoring-critical-care-reference-card.pdfBIS™ Brain Monitoring for Critical Care
The BIS™ monitor provides a direct measure of the effects of sedatives on the brain. BIS™ monitoring is most useful for patients who are chemically paralyzed ...
EEG bispectral index sensor guidance improves accuracy ...
BIS is a standardised and continuous assessment of the depth of sedation. In contrast to clinical assessment, EEG monitoring does not disturb the patient.
Application of Bispectral Index System (BIS) Monitor to ...
The application of BIS in combination with TCI may be beneficial for young children undergoing deep sedation for dental procedures.
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