IMPROVE Critical Care Study (Pilot)

NCT ID: NCT01361230

Last Updated: 2011-05-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2011-05-31

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.

Conditions

Sedated ICU Patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

Protocol

Using sedation monitoring and protocol

Group Type: EXPERIMENTAL

"Sedation Trial Monitor" is the name of the device used.

Intervention Type: DEVICE

This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group).

Control

Standard practice

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

"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).

Intervention Type: DEVICE

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

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Royal Infirmary of Edinburgh (Great Britain)

Principal Investigators

Kimmo Uutela, PhD

Role: STUDY_DIRECTOR

GEHC

Timothy Walsh, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Royal Infirmary of Edinburgh

Locations

Royal Infirmary Edinburgh (Great Britain) ward 118

Edinburgh, Scotland, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 26370687 (View on PubMed)

Other Identifiers

DOC0676170

Identifier Type: -

Identifier Source: org_study_id