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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00772213
First received: October 14, 2008
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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 Intervention
Acceleration of Procedure
Reduction of Number of Transports and Transfers
Involved Staff Member's Evaluation
Procedure: MIGTS treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Time to first CT scan [ Time Frame: first CT scan after arrival of emergency patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Staff member evaluation (Likert scale 1-5) [ Time Frame: end of emergency treatment (arrival ICU or death) ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: February 2003
Study Completion Date: April 2005
Primary Completion Date: April 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
Responsible Party: Thomas Gross, Prof. Dr. med., University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00772213     History of Changes
Other Study ID Numbers: EK 159/02
Study First Received: October 14, 2008
Last Updated: October 29, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
multiple trauma
outcome and process assessment

Additional relevant MeSH terms:
Emergencies
Multiple Trauma
Disease Attributes
Pathologic Processes
Wounds and Injuries

ClinicalTrials.gov processed this record on August 21, 2014