Body Core TemperatureNCT01400152
Active Warming in Prehospital Trauma Care
A study testing Additional active warming in people with Body Core Temperature and Thermal Comfort, run by Umeå University at 1 site in Sweden.
Trial summary
Prevention and treatment of hypothermia by active warming in prehospital trauma care is recommended but scientifical evidence of its effectiveness in a clinical setting is scarce. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Core Temperature, Thermal Comfort
- What is being tested?
- Additional active warming
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2007to May 2010
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were sequential trauma patients, age ≥ 18 years, who had sustained an injury outdoors and were transported by one of the participating EMS units.
Who cannot join
- Patients were excluded if initial level of consciousness was affected, (Glasgow Coma Scale < 15), if they required prehospital CPR or if duration of transportation was expected to be shorter than 10 minutes.
- As the aim of the study was to investigate the effect of active warming intervention in cold stressed patients, those patients who had already received active warming or had been taken indoors for more than 10 minutes before EMS unit arrival or had an initial cold discomfort rating ≤ 2 were also excluded.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery and Perioperative Sciences, Umeå University
Umeå, 901 85
About this study
Official title: The Effect of Active Warming in Prehospital Trauma Care During Road and Air Ambulance Transportation - a Clinical Randomized Trial
Prevention and treatment of hypothermia by active warming in prehospital trauma care is recommended but scientifical evidence of its effectiveness in a clinical setting is scarce. The objective of this study was to evaluate the effect of additional active warming during road or air ambulance transportation of trauma patients.
Patients were assigned to either passive warming with blankets or passive warming with blankets with the addition of an active warming intervention using a large chemical heat pad applied to the upper torso. Ear canal temperature, subjective sensation of cold discomfort and vital signs were monitored.
Read more
Mean core temperatures increased from 35.1°C (95% CI; 34.7-35.5 °C) to 36.0°C (95% CI; 35.7-36.3 °C) (p<0.05) in patients assigned to passive warming only (n=22) and from 35.6°C (95% CI; 35.2-36.0 °C) to 36.4°C (95% CI; 36.1-36.7°C) (p<0.05) in patients assigned to additional active warming (n=26) with no significant differences between the groups. Cold discomfort decreased in 2/3 of patients assigned to passive warming only and in all patients assigned to additional active warming, the difference in cold discomfort change being statistically significant (p<0.05). Patients assigned to additional active warming also presented a statistically significant decrease in heart rate and respiratory frequency (p<0.05).
In mildly hypothermic trauma patients, with preserved shivering capacity, adequate passive warming is an effective treatment to establish a slow rewarming rate and to reduce cold discomfort during prehospital transportation. However, the addition of active warming using a chemical heat pad applied to the torso will significantly improve thermal comfort even further and reduce the cold induced stress response.
- Conditions
- Body Core Temperature, Thermal Comfort
- Being tested
- Additional active warming
- Keywords
- Hypothermia, body temperature regulation,thermal comfort, active warming, passive warming, prehospital trauma care
- Medical subject headings
- Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional active warmingDevice
Chemical heat pad applied to the upper torso
| Study group | Role | What they receive |
|---|---|---|
| Passive warming with additional active warming | Active comparator | Not described Receives: Device: Additional active warming |
| Passive warming | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body core temperature
Measured: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.
Cold discomfort
Measured: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2011 (estimated)
- Study startDec 2007
- Primary completionMay 2010
- Study completionMay 2010
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 Body Core TemperatureStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Investigators
- Ulf Björnstig, MD, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01400152
- Sponsor's protocol ID
- jpl1
- Status last verified
- Jul 2011
- First submitted
- 18 Jul 2011
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lundgren P, Henriksson O, Naredi P, Bjornstig U. The effect of active warming in prehospital trauma care during road and air ambulance transportation - a clinical randomized trial. Scand J Trauma Resusc Emerg Med. 2011 Oct 21;19:59. doi: 10.1186/1757-7241-19-59.
PubMed 22017799
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Active Warming in Prehospital Trauma Care During Road and Air Ambulance Transportation - a Clinical Randomized Trial
- ClinicalTrials.gov ID
- NCT01400152
- Acronym / sponsor ID
- jpl1
- Conditions
- Body Core Temperature, Thermal Comfort
- Keywords
- Hypothermia, body temperature regulation,thermal comfort, active warming, passive warming, prehospital trauma care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Study start
- Dec 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 22 Jul 2011 (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.
Prevention and treatment of hypothermia by active warming in prehospital trauma care is recommended but scientifical evidence of its effectiveness in a clinical setting is scarce. The objective of this study was to evaluate the effect of additional active warming during road or air ambulance transportation of trauma patients.
Patients were assigned to either passive warming with blankets or passive warming with blankets with the addition of an active warming intervention using a large chemical heat pad applied to the upper torso. Ear canal temperature, subjective sensation of cold discomfort and vital signs were monitored.
Mean core temperatures increased from 35.1°C (95% CI; 34.7-35.5 °C) to 36.0°C (95% CI; 35.7-36.3 °C) (p<0.05) in patients assigned to passive warming only (n=22) and from 35.6°C (95% CI; 35.2-36.0 °C) to 36.4°C (95% CI; 36.1-36.7°C) (p<0.05) in patients assigned to additional active warming (n=26) with no significant differences between the groups. Cold discomfort decreased in 2/3 of patients assigned to passive warming only and in all patients assigned to additional active warming, the difference in cold discomfort change being statistically significant (p<0.05). Patients assigned to additional active warming also presented a statistically significant decrease in heart rate and respiratory frequency (p<0.05).
In mildly hypothermic trauma patients, with preserved shivering capacity, adequate passive warming is an effective treatment to establish a slow rewarming rate and to reduce cold discomfort during prehospital transportation. However, the addition of active warming using a chemical heat pad applied to the torso will significantly improve thermal comfort even further and reduce the cold induced stress response.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive warming with additional active warming | Active comparator | Device: Additional active warming |
| Passive warming | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects were sequential trauma patients, age ≥ 18 years, who had sustained an injury outdoors and were transported by one of the participating EMS units.
Key exclusion criteria (2 listed)
- Patients were excluded if initial level of consciousness was affected, (Glasgow Coma Scale < 15), if they required prehospital CPR or if duration of transportation was expected to be shorter than 10 minutes.
- As the aim of the study was to investigate the effect of active warming intervention in cold stressed patients, those patients who had already received active warming or had been taken indoors for more than 10 minutes before EMS unit arrival or had an initial cold discomfort rating ≤ 2 were also excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Additional active warmingChemical heat pad applied to the upper torso | Device | Passive warming with additional active warming |
Primary outcome
Body core temperature
Time frame: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.
Cold discomfort
Time frame: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.
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 22 Jul 2011.
- Derived from this study: PubMed 22017799Lundgren P, Henriksson O, Naredi P, Bjornstig U. The effect of active warming in prehospital trauma care during road and air ambulance transportation - a clinical randomized trial. Scand J Trauma Resusc Emerg Med. 2011 Oct 21;19:59. doi: 10.1186/1757-7241-19-59.
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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.
Ulf Björnstig, MD, PhD principal investigator
Umeå University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional active warming in people with Body Core Temperature and Thermal Comfort, run by Umeå University at 1 site in Sweden.
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 2 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 22 Jul 2011. 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 Sweden. 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?
Body core temperature (time frame: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.). The study lists 2 primary outcomes in all. 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 NCT01400152, 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 22 Jul 2011.