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Completed

NCT Number: NCT01361230

IMPROVE Critical Care Study (Pilot)

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.

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Royal Infirmary Edinburgh (Great Britain) ward 118

Edinburgh, Scotland, EH16 4SA, United Kingdom

Who can participate

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

  • 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

Treatment and study plan

"Sedation Trial Monitor" is the name of the device used.

Device

This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group).

Primary outcomes

  1. Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU

    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.

Secondary outcomes

  1. Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU.

    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.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
May 26, 2011
Registry last updated
May 26, 2011

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.