Hypothermia, Temperature Change, Body, Trauma
Conditions
Brief summary
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.
Interventions
DEVICEStandard of Care Group
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.
DEVICEActive Warming Group
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.
Sponsors
Dr. Asim Alam
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Proportion of patients who are hypothermic (\<36°C) upon discharge from the trauma bay. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Warming initiatives | Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first) | Total number of warming initiatives implemented by trauma care team |
| Transfused products | Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first) | Number of transfused blood products |
| Length of stay | Time of admission to discharge or up to 1 year after admission (whichever comes first) | Number of days patient stayed in hospital |
| 30 day mortality | Time of admission to discharge or up to 30 days after admission (whichever comes first) | Alive or deceased at 30 day |
Countries
Canada
Outcome results
None listed