Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket

Study Overview
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Brief Summary
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Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.

Detailed Description
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Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming (via an exothermic reaction) ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia. Near body core temperature is measured by a sublingual sensor as the gold standard of body core temperature measurement - the pulmonary artery catheter - is too invasive and not suited for this collective of patients in the emergency room setting. Blanket use will be randomized. Temperature will be taken at emergency room admission, after 15, 30 and 45 minutes of treatment as well as right before handing the patient over to the next caring unit (ICU, IMC, operating theatre etc.). If treatment time is shorter than expected measurement will stop at the latest possible point. Blankets will be applied to the patient once admission in the emergency room is complete and will only be lifted for interventions.

Official Title
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Trauma Patients and Hypothermia in the Emergency Room: a Trial Between Self-warming ReadyHeat® Blanket and Traditional Cotton Wool Blanket

Conditions
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Hypothermia, Trauma

Intervention / Treatment
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* Device: ReadyHeat® blanket
* Device: Cotton wool blanket


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Trauma patients ≥ 18 years of all severity stages including poly traumatized patients admissioned through the emergency room Exclusion Criteria: Patients < 18 years Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReadyHeat® blanket<br>Patient warming with ReadyHeat® blanket | Device: ReadyHeat® blanket<br>* Using ReadyHeat® blanket for patient warming<br>|
| Active Comparator: Cotton wool blanket<br>Patient warming with cotton wool blanket | Device: Cotton wool blanket<br>* Using cotton wool blanket for patient warming<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body core temperature at the end of completed emergency room treatment | Body core temperature taken after completed emergency room treatment incl. imaging. In most cases an average time frame < 60 min is maintained. | When handing the patient over to the next caring unit (ICU, operating theatre etc.) n most cases an average time frame < 60 min is maintained | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body core temperature during emergency room treatment | Body core temperature taken after emergency room admission and 15, 30 and 45 minutes after beginning of treatment | Temperature measurement: Admission, after 15, 30, 45 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypothermia, (Poly) Trauma, Emergency Room, Warming Blanket