Active Warming in Prehospital Trauma Care

Thermal Comfort Clinical Trial

Official title:

The Effect of Active Warming in Prehospital Trauma Care During Road and Air Ambulance Transportation - a Clinical Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01400152
• Other study ID #: jpl1
• Status: Completed
• Phase: N/A
• First received: July 18, 2011
• Last updated: July 21, 2011
• Start date: December 2007
• Est. completion date: May 2010

Study information

• Verified date: July 2011
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The Regional Ethical Review Board in Umeå.
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Body Core Temperature
• Thermal Comfort

Intervention

Device:
• Additional active warming
Chemical heat pad applied to the upper torso

Locations

Country	Name	City	State
Sweden	Department of Surgery and Perioperative Sciences, Umeå University	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Ministry of Health and Social Affairs, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body core temperature		From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.	No
Primary	Cold discomfort		From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.	No