Active Warming in Prehospital Trauma Care

NCT ID: NCT01400152

Last Updated: 2011-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2010-05-31

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.

Conditions

Body Core Temperature; Thermal Comfort

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Passive warming with additional active warming

Group Type: ACTIVE_COMPARATOR

Additional active warming

Intervention Type: DEVICE

Chemical heat pad applied to the upper torso

Passive warming

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Additional active warming

Chemical heat pad applied to the upper torso

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministry of Health and Social Affairs, Sweden

OTHER_GOV

Sponsor Role: collaborator

Umeå University

OTHER

Sponsor Role: lead

Responsible Party

Umeå University

Principal Investigators

Ulf Björnstig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Umeå University

Locations

Department of Surgery and Perioperative Sciences, Umeå University

Umeå, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 22017799 (View on PubMed)

Other Identifiers

jpl1

Identifier Type: -

Identifier Source: org_study_id