IMPROVE Critical Care Study (Pilot)

Study Overview
=================
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.

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

Conditions
-----------------
Sedated ICU Patients

Intervention / Treatment
-----------------
* Device: Sedation Trial Monitor is the name of the device used.


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Protocol<br>Using sedation monitoring and protocol | Device: Sedation Trial Monitor is the name of the device used.<br>* This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group).<br>|
| No Intervention: Control<br>Standard practice | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU | 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. | 8 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU. | 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. | 8 months |