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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Norwegian Air Ambulance Foundation
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01006837
First received: November 2, 2009
Last updated: October 8, 2013
Last verified: October 2013
  Purpose

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
Hypothermia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Hypothermia in the Trauma Patient - Temperature Changes During Transport and Initial Treatment in Hospital

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Survival to discharge [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Degree of hypothermia [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2009
Estimated Study Completion Date: August 2014
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Principal Investigator: Signy Camilla Eidstuen, med. student Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT01006837     History of Changes
Other Study ID Numbers: 2009/1263 (REK)
Study First Received: November 2, 2009
Last Updated: October 8, 2013
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

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

ClinicalTrials.gov processed this record on July 28, 2014