Clinical trial NCT03970915: Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients
Official title: Evaluation of Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients During Pre-hospital Medical Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Trauma, Psychological
Keywords: body warmer
pre-hospital
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study of adult patients with severe all-cause trauma having a body temperature less than 36°Celsius (C) that is managed by a Mobile Emergency Service team and oriented towards a Vital Emergency Room.

Currently two devices are used to warm patients during their care at the scene of an accident: a survival blanket and heating in the emergency vehicle. Despite these two devices many patients arrive in hypothermia (body temperature less than 36°C) in emergency departments. The objective of this study is to evaluate the effectiveness of a body warmer associated with standard warming devices on the correction of hypothermia compared to the standard procedure in severely traumatized patients with hypothermia .

It is a national multicentric study with 14 participating Mobile Emergency Service centers and hopefully will include 612 patients.

The study will be carried out according to a pattern of 28 successive periods of one week each during the winter period (October to April), for a total duration of 7 months. 14 action periods ON (warming standard procedure + body warmer) and 14 control periods OFF (warming standard procedure) will be run in random order for each center.


Eligibility criteria: Inclusion Criteria:

* Major patient with all-cause trauma Grade A or B
* Patient with a trans-tympanic body temperature of less than 36°Celsius (C) at primary management by terrestrial or heliport Mobile Emergency Service team.

Exclusion Criteria:

* Patient initially supported by a pre-hospital medical team who does not participate in the study,
* Patient with cardiopulmonary arrest at initial pre-hospital medical team management,
* Patient with bilateral otorrhagia (due to the non-feasibility of trans tympanic temperature),
* Patient with inguinal crease or subclavicular fossa injury,
* Patient with severe burn (Burnt Body Surface\> 20%),
* Patient deprived of liberty including patients with an electronic bracelet.

Primary outcomes:
measure: Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency
timeFrame: 4 hours
Secondary outcomes:
measure: Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room.
timeFrame: 4 hours
measure: Proportion of patients with coagulopathy on arrival at the emergency room.
timeFrame: 4 hours
measure: Proportion of patients with acidosis on arrival at the emergency room.
timeFrame: 4 hours
measure: Evaluation of mortality
timeFrame: 72 hours
measure: Evaluation of mortality (deaths before admission )
timeFrame: 72 hours
measure: Evaluation of mortality (cardio respiratory arrest)
timeFrame: 72 hours
measure: Loss of heat due to a drop of temperature
timeFrame: 4 hours
measure: First degree burn
timeFrame: 4 hours
measure: Patient feels cold
timeFrame: 4 hours
Other outcomes:
Locations:
city: Lyon
country: France
facility: SAMU 69 - SMUR - Hôpital Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Delphine HUGENSCHMITT
role: PRINCIPAL_INVESTIGATOR
References: