Clinical trial NCT03313258: Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Hypothermia
Trauma
Temperature Change, Body
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
First posted: 2017-10-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Hypothermic (<36°C) upon discharge from the trauma bay
timeFrame: Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
Secondary outcomes:
measure: Warming initiatives
timeFrame: Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
measure: Transfused products
timeFrame: Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
measure: Length of stay
timeFrame: Time of admission to discharge or up to 1 year after admission (whichever comes first)
measure: 30 day mortality
timeFrame: Time of admission to discharge or up to 30 days after admission (whichever comes first)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Asim Alam, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
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