IMPROVE Critical Care Study (Pilot)

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

Study Overview

• Status: Completed
• Conditions: Sedated ICU Patients
• Intervention / Treatment: Device: "Sedation Trial Monitor" is the name of the device used.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Scotland
    • Edinburgh, Scotland, United Kingdom, EH16 4SA
      • Royal Infirmary Edinburgh (Great Britain) ward 118

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard practice
Experimental: Protocol; Using sedation monitoring and protocol	Device: "Sedation 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).

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

Collaborators and Investigators

• Sponsor: GE Healthcare
• Investigators: Study Director: Kimmo Uutela, PhD, GEHC; Principal Investigator: Timothy Walsh, PhD MD, Royal Infirmary of Edinburgh

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: May 25, 2011
• First Posted (Estimate): May 26, 2011

Study Record Updates

• Last Update Posted (Estimate): May 26, 2011
• Last Update Submitted That Met QC Criteria: May 25, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: DOC0676170