Clinical trial NCT01361230: IMPROVE Critical Care Study (Pilot)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedated ICU Patients
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2011-05-26
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.


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

Primary outcomes:
measure: Proportion of time spent with low responsiveness (red colour code) during the first 48 hours in the ICU
timeFrame: 8 month period
Secondary outcomes:
measure: Proportion of time spent with RASS score -4/-5 during the first 48 hours in the ICU.
timeFrame: 8 months
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Royal Infirmary Edinburgh (Great Britain) ward 118
state: Scotland
Study officials:
affiliation: GEHC
name: Kimmo Uutela, PhD
role: STUDY_DIRECTOR
affiliation: Royal Infirmary of Edinburgh
name: Timothy Walsh, PhD MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaila M, Everingham K, Lapinlampi P, Peltola P, Sarkela MO, Uutela K, Walsh TS. A randomized controlled proof-of-concept trial of early sedation management using Responsiveness Index monitoring in mechanically ventilated critically ill patients. Crit Care. 2015 Sep 11;19(1):333. doi: 10.1186/s13054-015-1043-1.