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

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ClinicalTrials.gov Identifier: NCT03970915
Recruitment Status : Recruiting
First Posted : June 3, 2019
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment Phase
Hypothermia Trauma, Psychological Device: Body warmer Device: Standard warming procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 612 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Warm-up Efficiency by Body Warmer Versus Standard Procedure in Severely Traumatized Patients During Pre-hospital Medical Management
Actual Study Start Date : October 17, 2019
Estimated Primary Completion Date : June 17, 2021
Estimated Study Completion Date : June 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

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.




Primary Outcome Measures :
  1. Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency [ Time Frame: 4 hours ]
    Body temperature will be measured in trans-tympanic when the patient arrived in the Vital Emergency Room.


Secondary Outcome Measures :
  1. Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room. [ Time Frame: 4 hours ]
    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.

  2. Proportion of patients with coagulopathy on arrival at the emergency room. [ Time Frame: 4 hours ]
    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.

  3. Proportion of patients with acidosis on arrival at the emergency room. [ Time Frame: 4 hours ]
    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. Evaluation of mortality [ Time Frame: 72 hours ]
    Proportion of deaths at one month (72h after admission to emergency room).

  5. Evaluation of mortality (deaths before admission ) [ Time Frame: 72 hours ]
    Proportion of deaths before admission to emergency room.

  6. Evaluation of mortality (cardio respiratory arrest) [ Time Frame: 72 hours ]
    Proportion of cardio respiratory arrest before admission to emergency room.

  7. Loss of heat due to a drop of temperature [ Time Frame: 4 hours ]
  8. First degree burn [ Time Frame: 4 hours ]
  9. Patient feels cold [ Time Frame: 4 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03970915


Contacts
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Contact: Delphine HUGENSCHMITT 4 72 11 63 84 ext 33 delphine.hugenschmitt@chu-lyon.fr
Contact: Anne TERMOZ 4 27 85 63 00 ext 33 anne.termoz@chu-lyon.fr

Locations
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France
SAMU 69 - SMUR - Hôpital Edouard Herriot Recruiting
Lyon, France, 69003
Contact: Delphine HUGENSCHMITT, Nurse    +33 4 72 11 63 84    delphine.hugenschmitt@chu-lyon.fr   
Contact: Anne TERMOZ, CRA    +33 4 27 85 63 00    anne.termoz@chu-lyon.fr   
Principal Investigator: Delphine HUGENSCHMITT, Nurse         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Delphine HUGENSCHMITT Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03970915    
Other Study ID Numbers: 69HCL19_0033
2019-A01163-54 ( Other Identifier: ID-RCB )
First Posted: June 3, 2019    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
body warmer
pre-hospital
Additional relevant MeSH terms:
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Hypothermia
Psychological Trauma
Body Temperature Changes
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders