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

NCT06788925 | Enrolling By Invitation

• 1 other identifier: 2024-A02412-45
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Hypothermia; Lifejacket; Active device

Outcome Measures

Primary Outcomes (1)

• Statistical distribution of the temperature evolution

  The statistical distribution of the temperature evolution will be tested to verify whether it follows a normal distribution. The Shapiro-Wilk test and graphical methods will be used to assess this normality.

  From the intervention of the medical team on site until discharge from the hospital (1 month maximum)

Study Arms (2)

Experimental Arm with ThermUp chest protector

EXPERIMENTAL

Patients benefi ting from the Therm'Up heated chest protector

Device: Patients support with active thermic jacket

Control Arm with blanket

ACTIVE COMPARATOR

Patients supported with survival coverage (conventional PEC).

Device: Patients support with survival coverage

Interventions

Patients support with survival coverage DEVICE

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

Control Arm with blanket

Patients support with active thermic jacket DEVICE

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

Experimental Arm with ThermUp chest protector

Eligibility Criteria

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

You may qualify if:

• Age ≥ 18 years; Confi dential Page 7on 11 Version No. 2.0 of 2024/12/10
• Patient at risk of hypothermia presenting with grade A, or B, or C trauma or patient with hypothermia;
• Patient exposed to cold;
• Patient with hemorrhage;
• Patient burned over 20% of body surface area;
• Patient requiring an intervention delay of more than 30 minutes (between the arrival of the medical team on site and arrival at the hospital)

You may not qualify if:

• Patient with known ongoing hyperthermia and/or infections or body injuries such as burns in the area where the breastplate is positioned;
• Patient presenting with cardiac arrest before the arrival of the team;
• Patient with bilateral aural bleeding preventing continuous monitoring of the eardrum;
• Patient covered with insulating bubble wrap;
• Pregnant or breastfeeding woman;
• Patient already participating in an interventional clinical trial;
• Patient not receiving social security benefi ts;
• Adult patient subject to a legal protection measure, guardianship or deprived of liberty by a judicial or administrative decision.

Sponsors & Collaborators

• Chambery Hospital, France: collaborator
• Centre Hospitalier Annecy Genevois: collaborator
• University Hospital, Grenoble: collaborator
• ThermoTrauma: lead
• Digital Medical Hub: collaborator

Study Sites (1)

Grenoble Alpes University Hospital

Échirolles, 38130, France

Location

Related Links

• Official website of the device (active jacket)

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Thomas Spadoni

  Thermotrauma SAS

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 23, 2025
• Study Start: April 5, 2025
• Primary Completion: March 30, 2026
• Study Completion: March 30, 2026
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)