HypothermiaNCT01006837
Hypothermia in the Trauma Patient - When do Trauma Patients Get Cold?
An observational study of Hypothermia, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hypothermia
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2009to Aug 2014
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- trauma patient with a ISS 9 or above.
Who cannot join
- <12 years old
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hypothermia in the Trauma Patient - Temperature Changes During Transport and Initial Treatment in Hospital
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.
Read the 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).
- Conditions
- Hypothermia
- Keywords
- trauma patients, severe injury, ISS ≥9
- Medical subject headings
- Hypothermia, Wounds and Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival to discharge
Measured: one year
Secondary outcomes (1)
Degree of hypothermia
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionAug 2012
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypothermiaStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation, St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Eirik Skogvoll, MD, PhD, Study chair, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006837
- Sponsor's protocol ID
- 2009/1263 (REK)
- Status last verified
- Feb 2017
- First submitted
- 2 Nov 2009
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26585382
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypothermia in the Trauma Patient - Temperature Changes During Transport and Initial Treatment in Hospital
- ClinicalTrials.gov ID
- NCT01006837
- Acronym / sponsor ID
- 2009/1263 (REK)
- Conditions
- Hypothermia
- Keywords
- trauma patients, severe injury, ISS ≥9
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- Norwegian Air Ambulance Foundation, St. Olavs Hospital
- Study start
- Oct 2009
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 3 Nov 2009 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- trauma patient with a ISS 9 or above.
Key exclusion criteria (1 listed)
- <12 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival to discharge
Time frame: one year
1 secondary outcome
Degree of hypothermia
Time frame: one year
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 14 Feb 2017.
- Results publication: PubMed 26585382Uleberg 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.
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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.
Eirik Skogvoll, MD, PhD study chair
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypothermia, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 1 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 14 Feb 2017. 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 Norway. 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?
Survival to discharge (time frame: one year). 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 NCT01006837, which also lists 1 linked publication.
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 14 Feb 2017.