Clinical trial NCT01400152: Active Warming in Prehospital Trauma Care
Official title: The Effect of Active Warming in Prehospital Trauma Care During Road and Air Ambulance Transportation - a Clinical Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Core Temperature
Thermal Comfort
Keywords: Hypothermia, body temperature regulation,thermal comfort, active warming, passive warming, prehospital trauma care
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Social Affairs, Sweden
First posted: 2011-07-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Body core temperature
timeFrame: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.
measure: Cold discomfort
timeFrame: From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Surgery and Perioperative Sciences, Umeå University
Study officials:
affiliation: Umeå University
name: Ulf Björnstig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.