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Hypothermia in the Trauma Patient - When do Trauma Patients Get Cold?

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ClinicalTrials.gov Identifier: NCT01006837
Recruitment Status : Completed
First Posted : November 3, 2009
Last Update Posted : February 14, 2017
Sponsor:
Collaborators:
Norwegian Air Ambulance Foundation
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief Summary:
The purpose of this study is to analyze changes in core body- and skin temperature during pre-hospital and early in-hospital treatment of multi-traumatized patients. The researchers want to investigate when trauma patients get cold and to what extent.

Condition or disease
Hypothermia

Detailed Description:

Hypothermia is a common finding in severely traumatized patients. Decreases in core temperature during the course of initial evaluation and resuscitation are common, and can contribute to poor outcomes in multi-traumatized patients.

In this study the temperature will be recorded continually with multiple skin probes and an ear-probe from the site of the accident to arrival in the intensive care unit (including time in primary surgery, if any).


Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypothermia in the Trauma Patient - Temperature Changes During Transport and Initial Treatment in Hospital
Study Start Date : October 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Survival to discharge [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Degree of hypothermia [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients transported to St. Olavs Hospital (Trondheim, Norway), followed by an anesthesiologist from the norwegian air ambulance and taken care of by the trauma team in the emergency room.
Criteria

Inclusion Criteria:

  • trauma patient with a ISS 9 or above.

Exclusion Criteria:

  • <12 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006837


Locations
Norway
St. Olavs Hospital, department of anesthesia
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Norwegian Air Ambulance Foundation
St. Olavs Hospital
Investigators
Study Chair: Eirik Skogvoll, MD, PhD St. Olavs Hospital

Publications of Results:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01006837     History of Changes
Other Study ID Numbers: 2009/1263 (REK)
First Posted: November 3, 2009    Key Record Dates
Last Update Posted: February 14, 2017
Last Verified: February 2017

Keywords provided by Norwegian University of Science and Technology:
trauma patients
severe injury
ISS ≥9

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms