IMPROVE Critical Care Study (Pilot)

Not Applicable

Completed

• Conditions: Sedated ICU Patients
• Interventions: Device: "Sedation Trial Monitor" is the name of the device used.

• Registration Number: NCT01361230
• Lead Sponsor: GE Healthcare

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2010-04-19
• Primary Completion: 2010-09
• Status Verified: 2011-05
• Study Completion: 2011-05
• Study First Submitted QC: 2011-05-25
• Last Update Submitted: 2011-05-25
• Study First Posted: 2011-05-26
• Last Update Posted: 2011-05-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protocol	"Sedation Trial Monitor" is the name of the device used.	Using sedation monitoring and protocol

Primary Outcome Measures

Name	Time	Method
Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU	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 Outcome Measures

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

Trial Locations

Locations (1)

Royal Infirmary Edinburgh (Great Britain) ward 118; 🇬🇧 Edinburgh, Scotland, United Kingdom