Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial)

Study Overview
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Brief Summary
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Hypothermia amongst trauma patients is a persistent problem that increases the relative risk of transfusion as well as morbidity and mortality. The investigators propose to conduct a single-centered randomized controlled trial to determine if the use of a zero-heat flux (ZHF) temperature monitor can reduce the incidence of hypothermia amongst trauma patients discharged from the trauma bay (TB). All eligible trauma patients will be randomized to either a standard of care group or an active temperature monitoring group. In the active temperature monitoring group, a ZHF monitor will be placed on respective trauma patients to continuously record their temperatures after they enter the TB at a large tertiary trauma centre, Sunnybrook Health Sciences Centre (SHSC), in Toronto, ON. The investigators will determine if early continuous temperature monitoring can reduce the incidence of hypothermia upon discharge from the TB. Should early monitoring of severely injured trauma patients within the hospital improves discharge temperature, the foundation for two additional research studies will be laid. Firstly, the investigators will enter a vanguard phase of this trial and assess if early warming patients can improve morbidity and mortality in this patient population utilizing a multi-centered randomized controlled trial design. This will be further extended to test whether early monitoring can be applied in a pre-hospital setting (i.e. within ambulances and transport vehicles) to improve admission temperatures in the TB.

Official Title
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The Relationship Between the Use of a Continuous a Zero-heat Flux Temperature Monitor on Initial Discharge Hypothermia Rate Among Severely Injured Trauma Patients: a Randomized Controlled Trial. (RUZIT Trial)

Conditions
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Hypothermia, Trauma, Temperature Change, Body

Intervention / Treatment
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* Device: Standard of Care Group
* Device: Active Warming Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients >18 years of age Severely injured trauma patients with a Revised Trauma Score (RTS) ≤ 11 brought into the SHSC TB. Exclusion Criteria: Patients with blast injuries to the face or severe facial trauma will be excluded. Major burn patients - as they follow a separate care pathway at SHSC

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: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care Group<br>ZHF temperature monitor cable will be placed appropriately on the forehead by the care team under the direction of the research personnel. The research personnel will then connect this cable to a screen that is blinded to the care team but not to the research personnel. | Device: Standard of Care Group<br>* ZHF temperature monitor cable will be placed appropriately on the forehead by the care team under the direction of the research personnel. The research personnel will then connect this cable to a screen that is blinded to the care team but not to the research personnel.<br>|
| Experimental: Active Warming Group<br>ZHF temperature monitor cable will be placed appropriately on the forehead by the care team under the direction of the research personnel. The research personnel will then connect this cable to a screen that is un-blinded to everyone so healthcare practitioners will be able to visually detect continuous temperature readings from the ZHF monitor. | Device: Active Warming Group<br>* ZHF temperature monitor cable will be placed appropriately on the forehead by the care team under the direction of the research personnel. The research personnel will then connect this cable to a screen that is un-blinded to everyone so healthcare practitioners will be able to visually detect continuous temperature readings from the ZHF monitor.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypothermic (<36°C) upon discharge from the trauma bay | Proportion of patients who are hypothermic (<36°C) upon discharge from the trauma bay. | Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Warming initiatives | Total number of warming initiatives implemented by trauma care team | Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first) | 
| Transfused products | Number of transfused blood products | Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first) | 
| Length of stay | Number of days patient stayed in hospital | Time of admission to discharge or up to 1 year after admission (whichever comes first) | 
| 30 day mortality | Alive or deceased at 30 day | Time of admission to discharge or up to 30 days after admission (whichever comes first) |