An interventional study of Standard of Care Group and Active Warming Group in Hypothermia, Trauma and Temperature Change, Body, sponsored by Dr. Asim Alam. Withdrawn at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-28.
Sponsored by Dr. Asim Alam · Not applicable, Interventional, and Prevention
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.
449 studies on the registry are indexed under Hypothermia; 54 are open to participants now.
Browse Hypothermia studies →This is the only study on the registry with Dr. Asim Alam as lead sponsor.
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Exclusion Criteria:
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 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 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.
Hypothermic (<36°C) upon discharge from the trauma bay
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)
Warming initiatives
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)
Transfused products
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)
Length of stay
Number of days patient stayed in hospital
Time frame: Time of admission to discharge or up to 1 year after admission (whichever comes first)
30 day mortality
Alive or deceased at 30 day
Time frame: Time of admission to discharge or up to 30 days after admission (whichever comes first)
Plan to share: Undecided
This study is withdrawn, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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