Study to Actively Warm Trauma Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Hypothermia; Massive Blood Loss
• Intervention / Treatment: Device: Thermal Blanket

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Study blanket; 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 38˚C at any point.

Device: Thermal Blanket; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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])	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

Collaborators and Investigators

• Sponsor: Sunnybrook Health Sciences Centre
• Investigators: Principal Investigator: Luis T da Luz, MD, MSc, Sunnybrook Health Sciences Centre

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Actual): April 1, 2021
• Study Completion (Actual): April 1, 2021

Study Registration Dates

• First Submitted: March 30, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 22, 2020

Study Record Updates

• Last Update Posted (Actual): April 19, 2021
• Last Update Submitted That Met QC Criteria: April 16, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: trauma; bleeding; warming blankets
• Additional Relevant MeSH Terms: Body Temperature Changes; Hypothermia
• Other Study ID Numbers: STAY WARM Trial

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: IPD will not be shared with other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No