Trauma Reception and Resuscitation Project

February 10, 2013 updated by: Bayside Health

Trauma Reception and Resuscitation Project - 'Time for a New Approach'

Test the hypothesis that the implementation of real-time, computer-prompted algorithms in the first half hour of trauma management will result in a measurable reduction in management errors associated with the reception and resuscitation of major trauma patients.

Demonstrate that a reduction in management errors will translate into a reduction in morbidity and mortality.

Study Overview

Status

Completed

Conditions

Trauma

Intervention / Treatment

Device: Real time computer prompted trauma algorithms

Study Type

Interventional

Enrollment (Actual)

1171

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - The Alfred Hospital, Emergency and Trauma Centre, .

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria: All injured patients > 15 years old who are brought or present to the The Alfred Trauma Centre during the study period.

Exclusion Criteria: Stable Trauma patients (ie Pulse rate <100/minute, MAP >70mmHg, Hb >70, temperature >35 and <37.5, Spo2 >92%, GCS >13) undergoing secondary transfer from another hospital, where trauma occurred >6hrs prior to arrival.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Error rate per patient treated demonstrated by deviation from the algorithms

Secondary Outcome Measures

Outcome Measure
Missed injuries
Time to decision

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayside Health

Collaborators

National Trauma Research Institute

Victorian Trauma Foundation

Investigators

Principal Investigator: Mark Fitzgerald, MBBS, FACEM, MRCMA, The Alfred Hospital, Bayside Health, Melbourne, Australia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Fitzgerald M, Cameron P, Mackenzie C, Farrow N, Scicluna P, Gocentas R, Bystrzycki A, Lee G, O'Reilly G, Andrianopoulos N, Dziukas L, Cooper DJ, Silvers A, Mori A, Murray A, Smith S, Xiao Y, Stub D, McDermott FT, Rosenfeld JV. Trauma resuscitation errors and computer-assisted decision support. Arch Surg. 2011 Feb;146(2):218-25. doi: 10.1001/archsurg.2010.333.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 10, 2013

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Wounds and Injuries

Other Study ID Numbers

166/03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.