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

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ClinicalTrials.gov Identifier: NCT03313258
Recruitment Status : Not yet recruiting
First Posted : October 18, 2017
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Asim Alam, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Hypothermia Trauma Temperature Change, Body Device: Standard of Care Group Device: Active Warming Group Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
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)
Estimated Study Start Date : July 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 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.
Device: 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.

Experimental: 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.
Device: 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.




Primary Outcome Measures :
  1. 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) ]
    Proportion of patients who are hypothermic (<36°C) upon discharge from the trauma bay.


Secondary Outcome Measures :
  1. Warming initiatives [ Time Frame: 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

  2. Transfused products [ Time Frame: 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

  3. Length of stay [ Time Frame: Time of admission to discharge or up to 1 year after admission (whichever comes first) ]
    Number of days patient stayed in hospital

  4. 30 day mortality [ Time Frame: Time of admission to discharge or up to 30 days after admission (whichever comes first) ]
    Alive or deceased at 30 day



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03313258


Contacts
Contact: Asim Alam, MD, FRCPC 416-480-4864 asim.alam@sunnybrook.ca
Contact: Shelly Au, PhD,PMP,CCRP 416-480-6100 ext 89607 shelly.au@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N3M5
Sponsors and Collaborators
Dr. Asim Alam
Investigators
Principal Investigator: Asim Alam, MD, FRCPC Sunnybrook Health Sciences Centre

Publications:

Responsible Party: Dr. Asim Alam, MD, FRCPC, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03313258     History of Changes
Other Study ID Numbers: RUZIT
First Posted: October 18, 2017    Key Record Dates
Last Update Posted: April 18, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Wounds and Injuries
Hypothermia
Body Temperature Changes
Signs and Symptoms