Clinical Evaluation of an Innovative Hypothermia Management Strategy in Trauma Patients: Effectiveness of the Therm'Up Heating Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Statistical distribution of the temperature evolution
Study Overview
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.
Detailed Description
Hypothermia is defi ned as a core temperature below 35°C. Accidental hypothermia occurs when the human body loses more heat than it produces, resulting in a drop in body temperature.
Core body temperature is the standard physiological parameter for diagnosing and classifying the severity of hypothermia. Mild accidental hypothermia is defi ned as a core body temperature between 32 and 35°C, moderate hypothermia as a core temperature between 28 and 32°C, and severe hypothermia as a core temperature <28°C.
Trauma patients are at high risk of accidental hypothermia (body temperature ≤ 35°C). Hypothermia has signifi cant consequences on human physiology, including the cardiac, pulmonary, neurological, and hemostatic systems.
Hypothermia is of particular concern in trauma patients because it is associated with increased morbidity and mortality. In addition, hypothermia can infl uence blood coagulation by reducing platelet aggregation and increasing fi brinolysis. Three closely related elements: metabolic acidosis, coagulopathy, and hypothermia constitute the "lethal triad" of trauma. The presence of one or more of these elements during the management of a severely traumatized patient increases the risk of early mortality.
The occurrence of shivering in a patient is also an indicator of hypothermia. Shivering can increase oxygen consumption of muscle cells by up to 400%. The goal of prehospital care is to prevent the onset of shivering, making the use of passive warming measures crucial.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
Exclusion Criteria
- •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.
Arms & Interventions
Experimental Arm with ThermUp chest protector
Patients benefi ting from the Therm'Up heated chest protector
Intervention: Patients support with active thermic jacket (Device)
Control Arm with blanket
Patients supported with survival coverage (conventional PEC).
Intervention: Patients support with survival coverage (Device)
Outcomes
Primary Outcomes
Statistical distribution of the temperature evolution
Time Frame: From the intervention of the medical team on site until discharge from the hospital (1 month maximum)
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.
Secondary Outcomes
No secondary outcomes reported