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NCT Number: NCT03970915

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

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.

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Key information

Conditions

Hypothermia Body Temperature Changes Mental Disorders Pathological Conditions, Signs and Symptoms Psychological Trauma Signs and Symptoms Stress Disorders, Traumatic Trauma and Stressor Related Disorders Trauma, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SAMU 69 - SMUR - Hôpital Edouard Herriot

Lyon, 69003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Body warmer

Device

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.

Standard warming procedure

Device

Warming only according to the standard procedure : survival blanket and heating in the emergency vehicle.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: THERMOTRAUMA

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jun 3, 2019
Registry last updated
Jun 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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