IMPROVE Critical Care Study (Pilot)

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01361230
First received: April 19, 2010
Last updated: May 25, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Sedated ICU Patients
Device: "Sedation Trial Monitor" is the name of the device used.

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU [ Time Frame: 8 month period ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 74
Study Start Date: December 2009
Study Completion Date: May 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Protocol
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
Standard practice

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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:

  • Primary intracerebral disorder (includes cardiac arrest with probable hypoxic brain injury; intrac-ranial haemorrhage; head injury causing reduced conscious level prior to intubation)
  • Patient who is already awake at the time of enrolment defined as RASS ³ -1
  • Age <16 years
  • Patient not expected to survive the next 24 hours
  • Patient receiving long term ventilation prior to ICU admission
  • Patient with a long term tracheostomy prior to ICU admission
  • Patient transferred sedated and mechanically ventilated from another ICU unless recruitment is possible within 24 hours of first ICU admission
  • Patient receiving continuous neuromuscular blocking agent at the time of screening for enrolment
  • Previously enrolled in the trial during a separate ICU admission during this hospital stay
  • Status epilepticus
  • Confirmed meningitis or encephalitis at the time of screening for enrolment
  • Chronic neurological disease interfering with normal neuromuscular function, e.g. motor neurone disease, Guillain-Barre syndrome or inherited neuromyopathies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01361230

Locations
United Kingdom
Royal Infirmary Edinburgh (Great Britain) ward 118
Edinburgh, Scotland, United Kingdom, EH16 4SA
Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Kimmo Uutela, PhD GEHC
Principal Investigator: Timothy Walsh, PhD MD Royal Infirmary of Edinburgh
  More Information

No publications provided

Responsible Party: Professor Timothy Walsh, Principal investigator, Royal Infirmary of Edinburgh (Great Britain)
ClinicalTrials.gov Identifier: NCT01361230     History of Changes
Other Study ID Numbers: DOC0676170
Study First Received: April 19, 2010
Last Updated: May 25, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

ClinicalTrials.gov processed this record on September 16, 2014