Acceleration of ProcedureMIGTSNCT00772213
The Multifunctional Image Guided Therapy Suite (MIGTS) in Emergency Multiple Trauma Care
A study testing MIGTS treatment in people with Acceleration of Procedure and Reduction of Number of Transports and Transfers, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acceleration of Procedure, Reduction of Number of Transports and Transfers, Involved Staff Member's Evaluation
- What is being tested?
- MIGTS treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteSwitzerland
- Study dates
- Feb 2003to Apr 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- monotrauma or
- ISS < 16 or
- prior treatment in another hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Acceleration of Procedure, Reduction of Number of Transports and Transfers, Involved Staff Member's Evaluation
- Being tested
- MIGTS treatment
- Keywords
- multiple trauma, outcome and process assessment
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIGTS treatmentProcedure or surgery
Also called combined diagnostic and operation room
treatment of multiple trauma patients in the MIGTS
| Study group | Role | What they receive |
|---|---|---|
| MIGTS treatment | Experimental | controlled trial (quasi-randomized) versus controls (=conventional treatment not in the MIGTS) Receives: Procedure: MIGTS treatment |
| controls (=conventional treatment not in the MIGTS) | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first CT scan
Measured: first CT scan after arrival of emergency patient
Secondary outcomes (1)
Staff member evaluation (Likert scale 1-5)
Measured: end of emergency treatment (arrival ICU or death)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2008 (estimated)
- Study startFeb 2003
- Primary completionApr 2005
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Acceleration of ProcedureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss National Science Foundation, Scientific Foundation of the Swiss Accident Insurance Fond, Voluntary Academic Society, Basel, CARCAS Switzerland
- Responsible party
- Principal investigator, Thomas Gross, University Hospital, Basel, Switzerland
- Investigators
- Thomas Gross, Prof. Dr., Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00772213
- Sponsor's protocol ID
- EK 159/02
- Acronym
- MIGTS
- Status last verified
- Oct 2013
- First submitted
- 14 Oct 2008
- Last updated
- 30 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11699300Gross 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.
PubMed 16021393Gross 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.
PubMed 19937992
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Multifunctional Image Guided Therapy Suite (MIGTS) on Emergency Multiple Trauma Care - a Controlled Clinical Pilot Study
- ClinicalTrials.gov ID
- NCT00772213
- Acronym / sponsor ID
- MIGTS / EK 159/02
- Conditions
- Acceleration of Procedure, Reduction of Number of Transports and Transfers, Involved Staff Member's Evaluation
- Keywords
- multiple trauma, outcome and process assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss National Science Foundation, Scientific Foundation of the Swiss Accident Insurance Fond, Voluntary Academic Society, Basel, CARCAS Switzerland
- Study start
- Feb 2003
- Primary completion
- Apr 2005 (actual)
- Study completion
- Apr 2005 (actual)
- First posted
- 15 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIGTS treatment | Experimental | Procedure: MIGTS treatmentcontrolled trial (quasi-randomized) versus controls (=conventional treatment not in the MIGTS) |
| controls (=conventional treatment not in the MIGTS) | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- monotrauma or
- ISS < 16 or
- prior treatment in another hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MIGTS treatmentAlso: combined diagnostic and operation roomtreatment of multiple trauma patients in the MIGTS | Procedure or surgery | MIGTS treatment |
Primary outcome
Time to first CT scan
Time frame: first CT scan after arrival of emergency patient
1 secondary outcome
Staff member evaluation (Likert scale 1-5)
Time frame: end of emergency treatment (arrival ICU or death)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2013.
- Background: PubMed 11699300Messmer 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.
- Background: PubMed 16021393Gross 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 publication: PubMed 19937992Gross 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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Gross, Prof. Dr. principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIGTS treatment in people with Acceleration of Procedure and Reduction of Number of Transports and Transfers, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first CT scan (time frame: first CT scan after arrival of emergency patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00772213, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2013.