The Multifunctional Image Guided Therapy Suite (MIGTS) in Emergency Multiple Trauma Care (MIGTS)

October 29, 2013 updated by: Thomas Gross, University Hospital, Basel, Switzerland

The Impact of a Multifunctional Image Guided Therapy Suite (MIGTS) on Emergency Multiple Trauma Care - a Controlled Clinical Pilot Study

Controlled clinical intervention study comparing the treatment of multiple trauma patients in a newly developed combined diagnostic and operation room, the multifunctional image guided therapy suite (MIGTS) versus controls. The MIGTS proved to significantly accelerate the procedure and led to more satisfied team members.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Objective: Pilot evaluation to which extend the implementation of a newly developed combined diagnostic and operation room, the multifunctional image guided therapy suite (MIGTS) may influence the emergency treatment of multiply injured patients.

Summary Background: Controlled data on the impact of modern technology integration in multiple trauma management and involved care providers are lacking.

Methods: Quasi-randomized clinical intervention study comparing the treatment of multiple trauma patients (injury severity score, ISS >16) in the MIGTS versus controls.

Study Type

Interventional

Enrollment (Actual)

168

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

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital, CARCAS group

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • multiple trauma with
  • at least two abbreviated injury scoring (AIS) regions involved and
  • injury severity score (ISS)>16
  • primary hospital treatment at University Hospital Basel

Exclusion Criteria:

  • monotrauma or
  • ISS < 16 or
  • prior treatment in another hospital

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)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MIGTS treatment
controlled trial (quasi-randomized) versus controls (=conventional treatment not in the MIGTS)
Procedure: MIGTS treatment
treatment of multiple trauma patients in the MIGTS
Other Names:
  • combined diagnostic and operation room
No Intervention: controls (=conventional treatment not in the MIGTS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first CT scan
Time Frame: first CT scan after arrival of emergency patient
first CT scan after arrival of emergency patient

Secondary Outcome Measures

Outcome Measure
Time Frame
Staff member evaluation (Likert scale 1-5)
Time Frame: end of emergency treatment (arrival ICU or death)
end of emergency treatment (arrival ICU or death)

Collaborators and Investigators

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

Sponsor

University Hospital, Basel, Switzerland

Collaborators

Swiss National Science Foundation
Scientific Foundation of the Swiss Accident Insurance Fond
Voluntary Academic Society, Basel
CARCAS Switzerland

Investigators

  • Principal Investigator: Thomas Gross, Prof. Dr., University of Basel

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

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

February 1, 2003

Primary Completion (Actual)

April 1, 2005

Study Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

October 14, 2008

First Submitted That Met QC Criteria

October 14, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

October 30, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 159/02

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.

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