Royal Infirmary Edinburgh (Great Britain) ward 118
Edinburgh, Scotland, EH16 4SA, United Kingdom
NCT Number: NCT01361230
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.
Looking for future studies?
Notify Me16 year and older
All sexes
Interventional
Not applicable
Edinburgh, Scotland, EH16 4SA, United Kingdom
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients mechanically ventilated via an endotracheal tube and receiving intravenous sedation with a hypnotic agent (midazolam or other benzodiazepine) or propofol by continuous infusion.
Exclusion criteria
This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group).
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.
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.
GE Healthcare
Industry
PILOT STUDY: A Randomized Controlled Trial of Intensive Care Management of Sedation Using Patient Responsiveness in Critical Care IMPROVE Critical Care Study Pilot
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.