Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter
|ClinicalTrials.gov Identifier: NCT02175862|
Recruitment Status : Completed
First Posted : June 26, 2014
Last Update Posted : October 28, 2015
In May 2010 the first danish physician-staffed Helicopter Emergency Medical Service (PS-HEMS) was implemented in Region Zealand and the Capital Region (excluding Bornholm) of Denmark.
In relation to the introduction of PS-HEMS, a team of collaborators lead by Rasmus Hesselfeldt, conducted an observational study to investigate the possible effects on time to definitive care, secondary transfers and 30-day mortality in a "before" and "after" design.
Results showed reduced time from first dispatch to arrival at the trauma centre from 218 min to 90 min. Secondary transfers to the trauma centre dropped from 50 % to 34 % and 30-day mortality significantly reduced from 29 % to 14 % in the year after implementation.
The present study is an observational cohort study with long-term follow-up of the same trauma population as mentioned above. Patients were followed until may 1st, 2014.
Primary outcome is early retirement and secondary outcomes are quality of life and mortality.
The investigators hypothesize that a greater proportion of trauma patients in the "after" period will remain in occupation after approx. 3 to 4.5 years compared with trauma patients treated in the "before" period.
|Condition or disease|
|Wounds and Injuries|
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||1791 participants|
|Target Follow-Up Duration:||3 Years|
|Official Title:||Long-term Evaluation of Patients Treated by an Emergency Medical Helicopter|
|Study Start Date :||December 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Trauma patients before PS-HEMS
The "before" period was between december 1 2009 to april 30 2010 (five months).
Traume patients after PS-HEMS
The "after" period was between may 1 2010 to april 30 2011 (12 months).
- Labor market attachment [ Time Frame: 3 - 4.5 years after trauma ]Primary analysis: Risk of early retirement Secondary analysis: Risk of reduced work capability
- Health-related quality of life [ Time Frame: 3 - 4.5 years after trauma ]Health-related quality of life is measured using the Danish version of the Short Form 36 (SF-36) questionaire.
- All cause mortality [ Time Frame: 3 - 4.5 years after trauma ]Primary analysis: Risk of death. Secondary analysis: Predictors of death
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02175862
|Department Of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet|
|Copenhagen, Denmark, 2100|
|Principal Investigator:||Kamilia S. Funder, MD||Department of Anesthesia, Center of Head and Orthopedics, section 4231, Copenhagen University Hospital, Rigshospitalet|
|Study Director:||Jacob Steinmetz, MD, PhD||Trauma Center, Copenhagen University Hospital, Rigshospitalet|