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

Primary Purpose

Hypothermia, Trauma, Psychological

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Body warmer
Standard warming procedure
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring body warmer, pre-hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • SAMU 69 - SMUR - Hôpital Edouard Herriot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

ON (standard warming process + body warmer)

OFF / Control group (standard warming process )

Arm 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).

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
Evaluation of mortality
Proportion of deaths at one month (72h after admission to emergency room).
Evaluation of mortality (deaths before admission )
Proportion of deaths before admission to emergency room.
Evaluation of mortality (cardio respiratory arrest)
Proportion of cardio respiratory arrest before admission to emergency room.
Loss of heat due to a drop of temperature
First degree burn
Patient feels cold

Full Information

First Posted
May 15, 2019
Last Updated
May 31, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03970915
Brief Title
Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients
Acronym
THERMOTRAUMA
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 17, 2019 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Trauma, Psychological
Keywords
body warmer, pre-hospital

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ON (standard warming process + body warmer)
Arm Type
Experimental
Arm 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).
Arm Title
OFF / Control group (standard warming process )
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Body warmer
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Standard warming procedure
Intervention Description
Warming only according to the standard procedure : survival blanket and heating in the emergency vehicle.
Primary Outcome Measure Information:
Title
Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency
Description
Body temperature will be measured in trans-tympanic when the patient arrived in the Vital Emergency Room.
Time Frame
4 hours
Secondary Outcome Measure Information:
Title
Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room.
Description
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.
Time Frame
4 hours
Title
Proportion of patients with coagulopathy on arrival at the emergency room.
Description
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.
Time Frame
4 hours
Title
Proportion of patients with acidosis on arrival at the emergency room.
Description
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.
Time Frame
4 hours
Title
Evaluation of mortality
Description
Proportion of deaths at one month (72h after admission to emergency room).
Time Frame
72 hours
Title
Evaluation of mortality (deaths before admission )
Description
Proportion of deaths before admission to emergency room.
Time Frame
72 hours
Title
Evaluation of mortality (cardio respiratory arrest)
Description
Proportion of cardio respiratory arrest before admission to emergency room.
Time Frame
72 hours
Title
Loss of heat due to a drop of temperature
Time Frame
4 hours
Title
First degree burn
Time Frame
4 hours
Title
Patient feels cold
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine HUGENSCHMITT
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
SAMU 69 - SMUR - Hôpital Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France

12. IPD Sharing Statement

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

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