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

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ClinicalTrials.gov Identifier: NCT00772213
Recruitment Status : Completed
First Posted : October 15, 2008
Last Update Posted : October 30, 2013
Sponsor:
Collaborators:
Swiss National Science Foundation
Scientific Foundation of the Swiss Accident Insurance Fond
Voluntary Academic Society, Basel
CARCAS Switzerland
Information provided by (Responsible Party):
Thomas Gross, University Hospital, Basel, Switzerland

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acceleration of Procedure Reduction of Number of Transports and Transfers Involved Staff Member's Evaluation Procedure: MIGTS treatment Not Applicable

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  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of a Multifunctional Image Guided Therapy Suite (MIGTS) on Emergency Multiple Trauma Care - a Controlled Clinical Pilot Study
Study Start Date : February 2003
Actual Primary Completion Date : April 2005
Actual Study Completion Date : April 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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 Name: combined diagnostic and operation room
No Intervention: controls (=conventional treatment not in the MIGTS)



Primary Outcome Measures :
  1. Time to first CT scan [ Time Frame: first CT scan after arrival of emergency patient ]

Secondary Outcome Measures :
  1. Staff member evaluation (Likert scale 1-5) [ Time Frame: end of emergency treatment (arrival ICU or death) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00772213


Locations
Switzerland
University Hospital, CARCAS group
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
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