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

Primary Purpose

Hypothermia, Trauma, Temperature Change, Body

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Standard of Care Group
Active Warming Group
Sponsored by
Dr. Asim Alam
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothermia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care Group

Active Warming Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Hypothermic (<36°C) upon discharge from the trauma bay
Proportion of patients who are hypothermic (<36°C) upon discharge from the trauma bay.

Secondary Outcome Measures

Warming initiatives
Total number of warming initiatives implemented by trauma care team
Transfused products
Number of transfused blood products
Length of stay
Number of days patient stayed in hospital
30 day mortality
Alive or deceased at 30 day

Full Information

First Posted
October 4, 2017
Last Updated
February 26, 2020
Sponsor
Dr. Asim Alam
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1. Study Identification

Unique Protocol Identification Number
NCT03313258
Brief Title
Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial)
Acronym
RUZIT
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
PI left institution
Study Start Date
July 1, 2018 (Anticipated)
Primary Completion Date
March 1, 2019 (Anticipated)
Study Completion Date
May 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Asim Alam

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Trauma, Temperature Change, Body

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Active Warming Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Standard of Care Group
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Active Warming Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hypothermic (<36°C) upon discharge from the trauma bay
Description
Proportion of patients who are hypothermic (<36°C) upon discharge from the trauma bay.
Time Frame
Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
Secondary Outcome Measure Information:
Title
Warming initiatives
Description
Total number of warming initiatives implemented by trauma care team
Time Frame
Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
Title
Transfused products
Description
Number of transfused blood products
Time Frame
Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
Title
Length of stay
Description
Number of days patient stayed in hospital
Time Frame
Time of admission to discharge or up to 1 year after admission (whichever comes first)
Title
30 day mortality
Description
Alive or deceased at 30 day
Time Frame
Time of admission to discharge or up to 30 days after admission (whichever comes first)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Asim Alam, MD, FRCPC
Organizational Affiliation
Sunnybrook Health Sciences Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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3656464
Citation
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Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial)

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