Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients (THERMOTRAUMA)

Civil Hospices of Lyon

Status: Completed

Conditions: Trauma, Psychological; Hypothermia

Treatments: Device: Body warmer; Device: Standard warming procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT03970915

2019-A01163-54 (Other Identifier)

69HCL19_0033

Details and patient eligibility

About

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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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134 participants in 2 patient groups

ON (standard warming process + body warmer)

Experimental group

Description:

Patients included during the ON periods will constitute the experimental group. Warming will be provided by the body warmer in addition to the standard warming procedure (survival blanket and heating in the emergency vehicle).

Treatment:

Device: Body warmer

OFF / Control group (standard warming process )

Sham Comparator group

Description:

Patients included during the OFF periods will constitute the control group. Warming will be provided by the standard warming procedure : survival blanket and heating in the emergency vehicle.

Treatment:

Device: Standard warming procedure