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

NCT03970915 | Completed

• 2 other identifiers: 69HCL19_00332019-A01163-54
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia; Trauma, Psychological

Keywords

body warmer; pre-hospital

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

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

  4 hours

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

  4 hours

• Proportion of patients with acidosis on arrival at the emergency room.

  4 hours

• Evaluation of mortality

  72 hours

• Evaluation of mortality (deaths before admission )

  72 hours

Study Arms (2)

ON (standard warming process + body warmer)

EXPERIMENTAL

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

OFF / Control group (standard warming process )

SHAM COMPARATOR

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

Interventions

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.

ON (standard warming process + body warmer)

Standard warming procedure DEVICE

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

OFF / Control group (standard warming process )

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

SAMU 69 - SMUR - Hôpital Edouard Herriot

Lyon, 69003, France

Location

MeSH Terms

Conditions

Hypothermia; Psychological Trauma

Condition Hierarchy (Ancestors)

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

Study Officials

• Delphine HUGENSCHMITT

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: June 3, 2019
• Study Start: October 17, 2019
• Primary Completion: April 27, 2022
• Study Completion: April 27, 2022
• Last Updated: June 3, 2022

Record last verified: 2022-05

Locations

FR (1)