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Study to Actively Warm Trauma Patients

STudy to ActivelY WARM Trauma Patients (STAY WARM): A Feasibility Pilot Evaluation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04399902
Enrollment
15
Registered
2020-05-22
Start date
2020-10-05
Completion date
2021-04-01
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Massive Blood Loss

Keywords

warming blankets, trauma, bleeding

Brief summary

This study evaluates the feasibility of using thermal blankets to actively warm massively bleeding trauma patients at Sunnybrook Health Sciences Centre. It is hypothesized that either full thermal blankets or half thermal blankets will be a feasible intervention to implement for the care of massively bleeding trauma patients.

Detailed description

Hypothermia (core body temperature of \<36˚C), is a strong risk factor for mortality and poor outcomes in trauma patients due to its negative hemostatic, cardiovascular, respiratory, and renal effects. Current evidence has reported that massively bleeding hypothermic trauma patients have higher odds of mortality in the first 24 hours of hospital admission, increased length of stay, and increased need for transfusion. Standard hospital blankets are used to passively warm patients through resuscitation and treatment until arrival to the ICU. Interventions such as active heating through thermal blankets should be considered to prevent and treat hypothermia upon arrival of patients than standard warmed hospital blankets to prevent deleterious outcomes in this population.

Interventions

Ready-Heat 6-Panel Blanket (Military style, manufactured by Techtrade LLC). The 6-panel military-style blanket (86cm x 152 cm, 1.13kg) warms to 40˚C in approximately 15-20 minutes and maintains this temperature for 10 hours.

Sponsors

Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Any trauma patient requiring activation of the massive hemorrhage protocol (life- threatening bleeding situation requiring mobilization of blood bank, laboratory and clinical resources, and anticipated need for at least 4 units of red blood cells immediately and component therapy) during the hours when research staff are available. Normothermic (core body temperature between 36˚C or greater) will also be included, as core body temperature drops once resuscitation is initiated. * Hypothermic patients (temperature ≤ 35˚C) to whom MHP is NOT activated, when Dr. Luis da Luz/trauma fellow is on call as Trauma Team Leader will also be included.

Exclusion criteria

* Patients known to be pregnant * Patients who die in the trauma bay * Patients excluded at the discretion of the TTL based on use of the blanket not appearing feasible given the sustained injuries, multiple procedures being conducted in the trauma, or patients who seem to have unsurvivable injuries. * Patients admitted during study off-hours.

Design outcomes

Primary

MeasureTime frameDescription
Was the blanket applied to the patient?Through study completion, an average of 24 hoursBinary indication of whether or not the blanket is applied to the patient
Were patient temperatures recorded?Through study completion, an average of 24 hoursAt least 2 temperature recordings (1 in the trauma bay and 1 in the next phase of care - CT scanner suite, angioembolozation suite, emergency department \[ED\], or operating room), or preferentially, at the final phase of care usually the ICU or ED
Did the blanket remain on the patient?Through study completion, an average of 24 hoursBinary indication of whether or not the blanket is kept on the patient in each phase of care until arrival to ICU (1, 2, 3, 4, 5, and 6-hours post initial application of the blanket)

Secondary

MeasureTime frameDescription
Was the blanket placed directly on the patients skin?Through study completion, an average of 24 hoursNumber of times blanket is placed directly on the skin
Did the patient experience any redness and/or burns?Through study completion, an average of 24 hoursNumber of times redness and/or burns are reported by the patient and/or treating clinician
Cold Discomfort QuestionnaireUp to 2 weeksAssess cold discomfort of the patient during resuscitation (min value=0 \[warm\], max value=10 \[unbearably cold\])
Did the patients temperature exceed 38 degrees Celsius?Through study completion, an average of 24 hoursBinary outcome of whether patient temperature exceeded 38 degrees Celsius throughout phases of care

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026