Clinical Evaluation of Effectiveness of the "Therm'Up" Heating Device

Summary

Here's a concise summary in English without the numbers:

Hypothermia is defined as a core temperature below 35°C and occurs when the body loses more heat than it produces. It is classified by severity: mild (32-35°C), moderate (28-32°C), and severe (\<28°C). Trauma patients are particularly vulnerable, as hypothermia can affect cardiac, pulmonary, neurological, and coagulation systems, contributing to the "lethal triad" of metabolic acidosis, coagulopathy, and hypothermia, which increases early mortality risk.

Shivering, a key sign of hypothermia, significantly raises oxygen consumption, making its prevention during prehospital care critical. Passive warming measures, such as insulating survival blankets, are commonly used to prevent heat loss in emergencies. These blankets help maintain body temperature, protecting victims from cold and wind. Hypothermia prevalence among trauma patients on hospital arrival is high, emphasizing the importance of prehospital measures to limit its impact. However, active warming systems are often impractical in prehospital settings, leaving passive methods as the primary strategy.

Conditions

• Hypothermia Due to Cold Environment

Interventions

DEVICE

Patients support with survival coverage

Following calls to emergency medical services, handled by the ground SMUR/SAMU or the air SMUR (HéliSMUR), the operator collects essential information on the nature of the incident and the apparent condition of the injured. A medical team is thus mobilized on site. It takes over from the rescue team (e.g. the SDIS fi refi ghters) who are generally the fi rst to arrive on the scene. Eligible patients will be randomly assigned consecutively to one of two groups: control (use of the survival blanket) and experimental (use of the Therm'Up breastplate). Any traumatized person at risk of hypothermia or in hypothermia in a pre-hospital environment, having given verbal consent to participate in the study and meeting the inclusion criteria

DEVICE

Patients support with active thermic jacket

The intervention Description is exactly the same, except that the patient will be given a ThermUp jacket

Sponsors & Collaborators

• Digital Medical Hub

  collaborator OTHER

• Chambery Hospital, France

  collaborator UNKNOWN

• Centre Hospitalier Annecy Genevois

  collaborator OTHER

• University Hospital, Grenoble

  collaborator OTHER

• ThermoTrauma

  lead INDUSTRY

Principal Investigators

• Thomas Spadoni · Thermotrauma SAS

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-04-05

Primary Completion

2026-03-30

Completion

2026-03-30

Countries

• France

Study Locations