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

Not Applicable
Completed
Conditions
Hypothermia
Trauma, Psychological
Interventions
Device: Body warmer
Device: Standard warming procedure
Registration Number
NCT03970915
Lead Sponsor
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
134
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.
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ON (standard warming process + body warmer)Body warmerPatients 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).
OFF / Control group (standard warming process )Standard warming procedurePatients 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.
Primary Outcome Measures
NameTimeMethod
Proportion of patients with a temperature > 36°C when the patient arrived in the Vital Emergency4 hours

Body temperature will be measured in trans-tympanic when the patient arrived in the Vital Emergency Room.

Secondary Outcome Measures
NameTimeMethod
Evaluation of mortality72 hours

Proportion of deaths at one month (72h after admission to emergency room).

Proportion of patients with coagulopathy on arrival at the emergency room.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.

Evaluation of mortality (cardio respiratory arrest)72 hours

Proportion of cardio respiratory arrest before admission to emergency room.

Change in body temperature between initial treatment by the Mobile Emergency Service team and arrival at Vital Emergency Room.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.

Loss of heat due to a drop of temperature4 hours
Proportion of patients with acidosis on arrival at the emergency room.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.

Evaluation of mortality (deaths before admission )72 hours

Proportion of deaths before admission to emergency room.

First degree burn4 hours
Patient feels cold4 hours

Trial Locations

Locations (1)

SAMU 69 - SMUR - Hôpital Edouard Herriot

🇫🇷

Lyon, France

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