N/A
N=300
Combining Objective and Subjective Sedation Assessment Tools
Critical Illness
Bottom Line
View on ClinicalTrials.gov: NCT00734409 ↗Enrolled (actual)
300
Serious AEs
0.0%
Results posted
Sep 2012
Primary outcome: Primary: Mean Sedative Use — 13.35; 15.54 ml/hour
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bispectral Index (BIS) Monitor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Sedative Use |
13.35; 15.54 | — |
| SECONDARY Unplanned Self-device Removal Events |
0; 1 | — |
| SECONDARY Mean Days on Mechanical Ventilation |
7.43; 6.85 | — |
Summary
The purpose of this study is to determine if the use of a device called the BIS monitor in addition to the Richmond Agitation Sedation Scale will give better assessment of a subject's level of sedation.
Eligibility Criteria
Inclusion Criteria
- patient in the ICU
- continuous IV sedation with propofol midazolam or dexmedetomidine
- age > 18
- expected to require mechanical ventilation for >=48 hours
Exclusion Criteria
- prisoners
- no available space on forehead
- continuous electroencephalography(EEG) monitoring
- bifrontal brain injury
- barbiturate coma therapy
- known hypersensitivity to study medications
- high risk for ethanol (ETOH) withdrawal
- resuscitation from cardiac arrest without recovery of mental status
- moribund clinical state (death expected within 48 hours)
Data sourced from ClinicalTrials.gov (NCT00734409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.