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

Not Applicable

Withdrawn

• Conditions: Hypothermia; Trauma; Temperature Change, Body
• Interventions: Device: Active Warming Group; Device: Standard of Care Group

• Registration Number: NCT03313258
• Lead Sponsor: Dr. Asim Alam

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-04
• Study First Submitted QC: 2017-10-13
• Study First Posted: 2017-10-18
• Study Start: 2018-07-01
• Primary Completion: 2019-03-01
• Study Completion: 2019-05-31
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Active Warming Group	Active 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.
Standard of Care Group	Standard 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
30 day mortality	Time of admission to discharge or up to 30 days after admission (whichever comes first)	Alive or deceased at 30 day
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
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
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

Trial Locations

Locations (1)

Sunnybrook Health Sciences Centre; 🇨🇦 Toronto, Ontario, Canada