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Active Warming in Prehospital Trauma Care

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health and Social Affairs, Sweden
Information provided by:
Umeå University
ClinicalTrials.gov Identifier:
NCT01400152
First received: July 18, 2011
Last updated: July 21, 2011
Last verified: July 2011

July 18, 2011
July 21, 2011
December 2007
May 2010   (final data collection date for primary outcome measure)
  • Body core temperature [ Time Frame: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later. ] [ Designated as safety issue: No ]
  • Cold discomfort [ Time Frame: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01400152 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Not Provided
 
Active Warming in Prehospital Trauma Care
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.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Body Core Temperature
  • Thermal Comfort
Device: Additional active warming
Chemical heat pad applied to the upper torso
  • Active Comparator: Passive warming with additional active warming
    Intervention: Device: Additional active warming
  • No Intervention: Passive warming
Lundgren P, Henriksson O, Naredi P, Björnstig 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
May 2010
May 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects were sequential trauma patients, age ≥ 18 years, who had sustained an injury outdoors and were transported by one of the participating EMS units.

Exclusion Criteria:

  • 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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01400152
jpl1
Yes
Ulf Björnstig, Umeå University
Umeå University
Ministry of Health and Social Affairs, Sweden
Principal Investigator: Ulf Björnstig, MD, PhD Umeå University
Umeå University
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP