- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03313258
Zero Heat Flux Temp Monitor on Discharge Hypothermia Among Trauma Patients (RUZIT Trial) (RUZIT)
February 26, 2020 updated by: Dr. Asim Alam
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)
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M4N3M5
- Sunnybrook Health Sciences Centre
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
|
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
|
Duration of their stay in the trauma bay or up to 4 hours in the trauma bay (whichever comes first)
|
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
|
Time of admission to discharge or up to 1 year after admission (whichever comes first)
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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
|
Time of admission to discharge or up to 30 days after admission (whichever comes first)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Asim Alam, MD, FRCPC, Sunnybrook Health Sciences Centre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Rajagopalan S, Mascha E, Na J, Sessler DI. The effects of mild perioperative hypothermia on blood loss and transfusion requirement. Anesthesiology. 2008 Jan;108(1):71-7. doi: 10.1097/01.anes.0000296719.73450.52.
- Malone DL, Dunne J, Tracy JK, Putnam AT, Scalea TM, Napolitano LM. Blood transfusion, independent of shock severity, is associated with worse outcome in trauma. J Trauma. 2003 May;54(5):898-905; discussion 905-7. doi: 10.1097/01.TA.0000060261.10597.5C.
- Jurkovich GJ, Greiser WB, Luterman A, Curreri PW. Hypothermia in trauma victims: an ominous predictor of survival. J Trauma. 1987 Sep;27(9):1019-24.
- Sun Z, Honar H, Sessler DI, Dalton JE, Yang D, Panjasawatwong K, Deroee AF, Salmasi V, Saager L, Kurz A. Intraoperative core temperature patterns, transfusion requirement, and hospital duration in patients warmed with forced air. Anesthesiology. 2015 Feb;122(2):276-85. doi: 10.1097/ALN.0000000000000551.
- Eshraghi Y, Nasr V, Parra-Sanchez I, Van Duren A, Botham M, Santoscoy T, Sessler DI. An evaluation of a zero-heat-flux cutaneous thermometer in cardiac surgical patients. Anesth Analg. 2014 Sep;119(3):543-549. doi: 10.1213/ANE.0000000000000319.
- Luna GK, Maier RV, Pavlin EG, Anardi D, Copass MK, Oreskovich MR. Incidence and effect of hypothermia in seriously injured patients. J Trauma. 1987 Sep;27(9):1014-8. doi: 10.1097/00005373-198709000-00010.
- Wang HE, Callaway CW, Peitzman AB, Tisherman SA. Admission hypothermia and outcome after major trauma. Crit Care Med. 2005 Jun;33(6):1296-301. doi: 10.1097/01.ccm.0000165965.31895.80.
- Shafi S, Elliott AC, Gentilello L. Is hypothermia simply a marker of shock and injury severity or an independent risk factor for mortality in trauma patients? Analysis of a large national trauma registry. J Trauma. 2005 Nov;59(5):1081-5. doi: 10.1097/01.ta.0000188647.03665.fd.
- Perlman R, Callum J, Laflamme C, Tien H, Nascimento B, Beckett A, Alam A. A recommended early goal-directed management guideline for the prevention of hypothermia-related transfusion, morbidity, and mortality in severely injured trauma patients. Crit Care. 2016 Apr 20;20(1):107. doi: 10.1186/s13054-016-1271-z.
- Bukur M, Hadjibashi AA, Ley EJ, Malinoski D, Singer M, Barmparas G, Margulies D, Salim A. Impact of prehospital hypothermia on transfusion requirements and outcomes. J Trauma Acute Care Surg. 2012 Nov;73(5):1195-201. doi: 10.1097/TA.0b013e31826fc7d9.
- Bochicchio GV, Napolitano L, Joshi M, Bochicchio K, Meyer W, Scalea TM. Outcome analysis of blood product transfusion in trauma patients: a prospective, risk-adjusted study. World J Surg. 2008 Oct;32(10):2185-9. doi: 10.1007/s00268-008-9655-0.
- Perel P, Clayton T, Altman DG, Croft P, Douglas I, Hemingway H, Hingorani A, Morley KI, Riley R, Timmis A, Van der Windt D, Roberts I; PROGRESS Partnership. Red blood cell transfusion and mortality in trauma patients: risk-stratified analysis of an observational study. PLoS Med. 2014 Jun 17;11(6):e1001664. doi: 10.1371/journal.pmed.1001664. eCollection 2014 Jun.
- Dunne JR, Riddle MS, Danko J, Hayden R, Petersen K. Blood transfusion is associated with infection and increased resource utilization in combat casualties. Am Surg. 2006 Jul;72(7):619-25; discussion 625-6.
- Bochicchio GV, Napolitano L, Joshi M, Bochicchio K, Shih D, Meyer W, Scalea TM. Blood product transfusion and ventilator-associated pneumonia in trauma patients. Surg Infect (Larchmt). 2008 Aug;9(4):415-22. doi: 10.1089/sur.2006.069.
- Reynolds BR, Forsythe RM, Harbrecht BG, Cuschieri J, Minei JP, Maier RV, Moore EE, Billiar EE, Peitzman AB, Sperry JL; Inflammation and Host Response to Injury Investigators. Hypothermia in massive transfusion: have we been paying enough attention to it? J Trauma Acute Care Surg. 2012 Aug;73(2):486-91.
- Lapostolle F, Sebbah JL, Couvreur J, Koch FX, Savary D, Tazarourte K, Egman G, Mzabi L, Galinski M, Adnet F. Risk factors for onset of hypothermia in trauma victims: the HypoTraum study. Crit Care. 2012 Jul 31;16(4):R142. doi: 10.1186/cc11449.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 1, 2018
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
May 31, 2019
Study Registration Dates
First Submitted
October 4, 2017
First Submitted That Met QC Criteria
October 13, 2017
First Posted (Actual)
October 18, 2017
Study Record Updates
Last Update Posted (Actual)
February 28, 2020
Last Update Submitted That Met QC Criteria
February 26, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RUZIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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