NCT01361230

IMPROVE Critical Care Study (Pilot)

PILOT STUDY: A Randomized Controlled Trial of Intensive Care Management of Sedation Using Patient Responsiveness in Critical Care IMPROVE Critical Care Study Pilot

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Sedated ICU Patients

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-09-01
• Completion: 2011-05-01
• First posted: 2011-05-26
• Last updated: 2011-05-26

Locations

1 site across 1 country: United Kingdom