NCT01006837

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 2, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2.8 years

First QC Date

November 2, 2009

Last Update Submit

February 12, 2017

Conditions

Keywords

trauma patientssevere injuryISS ≥9

Outcome Measures

Primary Outcomes (1)

  • Survival to discharge

    one year

Secondary Outcomes (1)

  • Degree of hypothermia

    one year

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • trauma patient with a ISS 9 or above.

You may not qualify if:

  • \<12 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Olavs Hospital, department of anesthesia

Trondheim, Norway

Location

Related Publications (1)

  • Uleberg O, Eidstuen SC, Vangberg G, Skogvoll E. Temperature measurements in trauma patients: is the ear the key to the core? Scand J Trauma Resusc Emerg Med. 2015 Nov 19;23:101. doi: 10.1186/s13049-015-0178-z.

MeSH Terms

Conditions

HypothermiaWounds and Injuries

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eirik Skogvoll, MD, PhD

    St. Olavs Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2009

First Posted

November 3, 2009

Study Start

October 1, 2009

Primary Completion

August 1, 2012

Study Completion

August 1, 2014

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations