IMPROVE Critical Care Study (Pilot) - Full Text View

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:

MedlinePlus related topics: Critical Care

U.S. FDA Resources

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

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 May 16, 2013