Bispectral Index Monitoring To Guide Sedation In The Critical Care Setting
BIS65
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
A randomized, control trial to compare the total dose of sedatives use in patients over 65 years admitted to the intensive care unit, guiding sedation by monitoring with BIS® versus monitoring with the exclusive use of sedation scales. The study will include all patients over 65 years who enter the intensive care unit of the University Hospital of Bellvitge affected with medical or surgical pathology of non neurological etiology who require sedation for more than 24 hours to maintain adaptation to mechanical ventilation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2015
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
September 19, 2016
CompletedFirst Posted
Study publicly available on registry
September 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2018
CompletedSeptember 21, 2016
September 1, 2016
3.1 years
September 19, 2016
September 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Total Dose of sedation
Total dose of sedatives administered in the intervention group compared with the control group.
Two years
Study Arms (2)
BIS™ Brain Monitoring System
ACTIVE COMPARATORBIS monitoring to adjust sedation in order to maintain values between 50-60
RASS Monitorization
PLACEBO COMPARATORsedation was adjusted with the exclusive useof Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2.
Interventions
The intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60
control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2
Eligibility Criteria
You may qualify if:
- Patients over 65 yers
- Patients admitted to teintensive care unit of the University Hospital of Bellvitge medical or surgical pathology of neurological etiology
- Patiens requiring sedation for more than 24 hours
You may not qualify if:
- Patients less than 65 years
- Patients admitted to the ICU with Neurological condition.
- Postoperative patients admitted and extubation is expected within 24 hours.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Fraser GL, Riker RR. Sedation and analgesia in the critically ill adult. Curr Opin Anaesthesiol. 2007 Apr;20(2):119-23. doi: 10.1097/ACO.0b013e32808255b4.
PMID: 17413394BACKGROUNDCarrasco G. Instruments for monitoring intensive care unit sedation. Crit Care. 2000;4(4):217-25. doi: 10.1186/cc697. Epub 2000 Jul 13.
PMID: 11094504BACKGROUNDDe Deyne C, Struys M, Decruyenaere J, Creupelandt J, Hoste E, Colardyn F. Use of continuous bispectral EEG monitoring to assess depth of sedation in ICU patients. Intensive Care Med. 1998 Dec;24(12):1294-8. doi: 10.1007/s001340050765.
PMID: 9885883BACKGROUND
Study Officials
- STUDY DIRECTOR
Luisa Corral, MD
Barcelona University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Intensivist
Study Record Dates
First Submitted
September 19, 2016
First Posted
September 21, 2016
Study Start
May 1, 2015
Primary Completion
June 1, 2018
Study Completion
September 1, 2018
Last Updated
September 21, 2016
Record last verified: 2016-09