IMPROVE Critical Care Study (Pilot)
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|ClinicalTrials.gov Identifier: NCT01361230|
Recruitment Status : Completed
First Posted : May 26, 2011
Last Update Posted : May 26, 2011
|Condition or disease||Intervention/treatment||Phase|
|Sedated ICU Patients||Device: "Sedation Trial Monitor" is the name of the device used.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||74 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||PILOT STUDY: A Randomized Controlled Trial of Intensive Care Management of Sedation Using Patient Responsiveness in Critical Care IMPROVE Critical Care Study Pilot|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||May 2011|
Using sedation monitoring and protocol
Device: "Sedation Trial Monitor" is the name of the device used.
This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group).
No Intervention: Control
- Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU [ Time Frame: 8 month period ]The main purpose in the statistical analysis is not to test the statistical significance of the differences but to provide descriptive statistics for the full outcome study plan.
- Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU. [ Time Frame: 8 months ]The main purpose in the statistical analysis is not to test the statistical significance of the differences but to provide descriptive statistics for the full outcome study plan.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01361230
|Royal Infirmary Edinburgh (Great Britain) ward 118|
|Edinburgh, Scotland, United Kingdom, EH16 4SA|
|Study Director:||Kimmo Uutela, PhD||GEHC|
|Principal Investigator:||Timothy Walsh, PhD MD||Royal Infirmary of Edinburgh|