search
Back to results

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

Primary Purpose

Acceleration of Procedure, Reduction of Number of Transports and Transfers, Involved Staff Member's Evaluation

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
MIGTS treatment
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acceleration of Procedure focused on measuring multiple trauma, outcome and process assessment

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital, CARCAS group

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MIGTS treatment

controls (=conventional treatment not in the MIGTS)

Arm Description

controlled trial (quasi-randomized) versus controls (=conventional treatment not in the MIGTS)

Outcomes

Primary Outcome Measures

Time to first CT scan

Secondary Outcome Measures

Staff member evaluation (Likert scale 1-5)

Full Information

First Posted
October 14, 2008
Last Updated
October 29, 2013
Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation, Scientific Foundation of the Swiss Accident Insurance Fond, Voluntary Academic Society, Basel, CARCAS Switzerland
search

1. Study Identification

Unique Protocol Identification Number
NCT00772213
Brief Title
The Multifunctional Image Guided Therapy Suite (MIGTS) in Emergency Multiple Trauma Care
Acronym
MIGTS
Official Title
The Impact of a Multifunctional Image Guided Therapy Suite (MIGTS) on Emergency Multiple Trauma Care - a Controlled Clinical Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
April 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Basel, Switzerland
Collaborators
Swiss National Science Foundation, Scientific Foundation of the Swiss Accident Insurance Fond, Voluntary Academic Society, Basel, CARCAS Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acceleration of Procedure, Reduction of Number of Transports and Transfers, Involved Staff Member's Evaluation
Keywords
multiple trauma, outcome and process assessment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MIGTS treatment
Arm Type
Experimental
Arm Description
controlled trial (quasi-randomized) versus controls (=conventional treatment not in the MIGTS)
Arm Title
controls (=conventional treatment not in the MIGTS)
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
MIGTS treatment
Other Intervention Name(s)
combined diagnostic and operation room
Intervention Description
treatment of multiple trauma patients in the MIGTS
Primary Outcome Measure Information:
Title
Time to first CT scan
Time Frame
first CT scan after arrival of emergency patient
Secondary Outcome Measure Information:
Title
Staff member evaluation (Likert scale 1-5)
Time Frame
end of emergency treatment (arrival ICU or death)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Gross, Prof. Dr.
Organizational Affiliation
University of Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital, CARCAS group
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
11699300
Citation
Messmer P, Jacob AL, Fries E, Gross T, Suhm N, Steinbrich W, Frede KE, Schneider T, Regazzoni P. [Technology integration and process management. Concept and implementation of a new platform for simultaneous diagnosis and therapy of acutely ill and injured patients and for elective computer assisted surgery (CAS)]. Unfallchirurg. 2001 Oct;104(10):1025-30. doi: 10.1007/s001130170047. German.
Results Reference
background
PubMed Identifier
16021393
Citation
Gross T, Amsler F, Ummenhofer W, Zuercher M, Regazzoni P, Jacob AL, Huegli RW, Messmer P. [Interdisciplinary emergency room management of trauma patients from the standpoint of coworkers]. Chirurg. 2005 Oct;76(10):959-66. doi: 10.1007/s00104-005-1068-0. German.
Results Reference
background
PubMed Identifier
19937992
Citation
Gross T, Messmer P, Amsler F, Fuglistaler-Montali I, Zurcher M, Hugli RW, Regazzoni P, Jacob AL. Impact of a multifunctional image-guided therapy suite on emergency multiple trauma care. Br J Surg. 2010 Jan;97(1):118-27. doi: 10.1002/bjs.6842.
Results Reference
result
Links:
URL
http://carcas.wordpress.com
Description
Related Info

Learn more about this trial

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

We'll reach out to this number within 24 hrs