Sedated ICU Patients
Conditions
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.
Interventions
DEVICESedation 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).
Sponsors
GE Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United Kingdom
Outcome results
None listed