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IMPROVE Critical Care Study (Pilot)

NCT01361230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2011-05-26

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Kimmo Uutela, PhD · GEHC

  • Timothy Walsh, PhD MD · Royal Infirmary of Edinburgh

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2010-09-30
Completion
2011-05-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01361230 on ClinicalTrials.gov