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临床试验/NCT01400152
NCT01400152已完成不适用

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

Umeå University2 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
2
主要终点
Body core temperature

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Body core temperature

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

Cold discomfort

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

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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