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

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

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia; Trauma, Psychological
• Intervention / Treatment: Device: Body warmer; Device: Standard warming procedure

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69003
    • SAMU 69 - SMUR - Hôpital Edouard Herriot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ON (standard warming process + body warmer); 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).	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.
Sham Comparator: OFF / Control group (standard warming process ); 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.	Device: Standard warming procedure; Warming only according to the standard procedure : survival blanket and heating in the emergency vehicle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency	Body temperature will be measured in trans-tympanic when the patient arrived in the Vital Emergency Room.	4 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room.	Body temperature will be measured in trans-tympanic every 15 minutes between initial treatment by the pre-hospital medical team and arrival at emergency room.	4 hours
Proportion of patients with coagulopathy on arrival at the emergency room.	Coagulopathy refers to disorders of blood coagulation whether they are pathological thrombosis or haemorrhagic syndromes. The coagulopathy criteria appear early and their measurements are systematically carried on admission to the emergency room.	4 hours
Proportion of patients with acidosis on arrival at the emergency room.	Acidosis is a disorder of the acid-base balance of the body corresponding to an increase in the concentration of acid in plasma and interstitial fluids. It can be metabolic or respiratory. In the case of a state of shock, lactic acid occurs in situations where the tissues of the body are poorly irrigated and lack oxygen.	4 hours
Evaluation of mortality	Proportion of deaths at one month (72h after admission to emergency room).	72 hours
Evaluation of mortality (deaths before admission )	Proportion of deaths before admission to emergency room.	72 hours
Evaluation of mortality (cardio respiratory arrest)	Proportion of cardio respiratory arrest before admission to emergency room.	72 hours
Loss of heat due to a drop of temperature		4 hours
First degree burn		4 hours
Patient feels cold		4 hours

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Delphine HUGENSCHMITT, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2019
• Primary Completion (Actual): April 27, 2022
• Study Completion (Actual): April 27, 2022

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 28, 2019
• First Posted (Actual): June 3, 2019

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: pre-hospital; body warmer
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Body Temperature Changes; Stress Disorders, Traumatic; Hypothermia; Psychological Trauma
• Other Study ID Numbers: 69HCL19_0033; 2019-A01163-54 (Other Identifier: ID-RCB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No