Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Hypothermia (core body temperature of <36ËšC), 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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study blanket | Experimental | Two standard warmed hospital blankets will be placed on top of the patient and the study blanket on top of the standard warmed blankets, covering as much of the patient as possible, at the discretion of the care team. At all times, clinicians should ensure that the study blanket does not touch the patient's bare skin.The blanket will remain on the patient through their path of care, and removed from the patient at arrival to the ICU/final phase of care, or if the patient temperature exceeds 38ËšC at any point. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermal Blanket | Device | 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 40ËšC in approximately 15-20 minutes and maintains this temperature for 10 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| Was the blanket applied to the patient? | Binary indication of whether or not the blanket is applied to the patient | Through study completion, an average of 24 hours |
| Were patient temperatures recorded? | At 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 | Through study completion, an average of 24 hours |
| Did the blanket remain on the patient? | Binary 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) | Through study completion, an average of 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Was the blanket placed directly on the patients skin? | Number of times blanket is placed directly on the skin | Through study completion, an average of 24 hours |
| Cold Discomfort Questionnaire | Assess cold discomfort of the patient during resuscitation (min value=0 [warm], max value=10 [unbearably cold]) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Luis T da Luz, MD, MSc | Sunnybrook Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39112757 | Derived | Strauss R, Kron A, Callum J, Armali C, Modi D, Notario L, D'Empaire PP, Tillmann BW, Pannell D, Tien H, Nathens A, Beckett A, da Luz LT. STudy to ActivelY WARM trauma patients (STAY WARM): a pilot study assessing feasibility of self-warming blankets in patients requiring a massive hemorrhage protocol activation. Eur J Trauma Emerg Surg. 2024 Oct;50(5):2289-2294. doi: 10.1007/s00068-024-02612-w. Epub 2024 Aug 7. |
Not provided
Not provided
IPD will not be shared with other researchers
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007035 | Hypothermia |
| D014947 | Wounds and Injuries |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Up to 2 weeks |
| Did the patients temperature exceed 38 degrees Celsius? | Binary outcome of whether patient temperature exceeded 38 degrees Celsius throughout phases of care | Through study completion, an average of 24 hours |
| Did the patient experience any redness and/or burns? | Number of times redness and/or burns are reported by the patient and/or treating clinician | Through study completion, an average of 24 hours |