NCT01400152

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 22, 2011

Completed
Last Updated

July 22, 2011

Status Verified

July 1, 2011

Enrollment Period

2.4 years

First QC Date

July 18, 2011

Last Update Submit

July 21, 2011

Conditions

Keywords

Hypothermia, body temperature regulation,thermal comfort, active warming, passive warming, prehospital trauma care

Outcome Measures

Primary Outcomes (2)

  • Body core temperature

    From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.

  • Cold discomfort

    From initial assessment upon arrival of EMS crew until second assessment about 30 minutes later.

Study Arms (2)

Passive warming with additional active warming

ACTIVE COMPARATOR
Device: Additional active warming

Passive warming

NO INTERVENTION

Interventions

Chemical heat pad applied to the upper torso

Passive warming with additional active warming

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery and Perioperative Sciences, Umeå University

Umeå, 901 85, Sweden

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ulf Björnstig, MD, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 22, 2011

Study Start

December 1, 2007

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 22, 2011

Record last verified: 2011-07

Locations