The Pilot Clinical Investigation planned is a prospective, unblinded randomized pilot trial comparing sedation management using a protocol based on responsiveness with standard sedation management. The hypothesis is that responsiveness will improve a range of patient-based and economic outcomes, including the duration of mechanical ventilation and duration of coma in the ICU. The purpose of the pilot study is to gather information for designing a full study that might show the validity of the outcome hypothesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
74
This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group).
Royal Infirmary Edinburgh (Great Britain) ward 118
Edinburgh, Scotland, United Kingdom
Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU
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.
Time frame: 8 month period
Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU.
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.
Time frame: 8 months
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