NCT03970915

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

Evaluation of Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients During Pre-hospital Medical Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypothermia
• Trauma, Psychological

Interventions

Type	Name	Description
DEVICE	Body warmer	The body warmer will be wrapped in a waterproof treatment field to avoid the risk of burns, 2 body warmer will be applied on the inguinal crease and 2 on the subclavicular fossa.
DEVICE	Standard warming procedure	Warming only according to the standard procedure : survival blanket and heating in the emergency vehicle.

Timeline

• Start date: 2019-10-17
• Primary completion: 2022-04-27
• Completion: 2022-04-27
• First posted: 2019-06-03
• Last updated: 2022-06-03

Locations

1 site across 1 country: France