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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00772213
Other study ID # EK 159/02
Secondary ID
Status Completed
Phase N/A
First received October 14, 2008
Last updated October 29, 2013
Start date February 2003
Est. completion date April 2005

Study information

Verified date October 2013
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 168
Est. completion date April 2005
Est. primary completion date April 2005
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
MIGTS treatment
treatment of multiple trauma patients in the MIGTS

Locations

Country Name City State
Switzerland University Hospital, CARCAS group Basel

Sponsors (5)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland CARCAS Switzerland, Scientific Foundation of the Swiss Accident Insurance Fond, Swiss National Science Foundation, Voluntary Academic Society, Basel

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. German. — View Citation

Gross T, Messmer P, Amsler F, Füglistaler-Montali I, Zürcher M, Hügli 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. — View 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. German. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first CT scan first CT scan after arrival of emergency patient No
Secondary Staff member evaluation (Likert scale 1-5) end of emergency treatment (arrival ICU or death) No

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