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Study to Actively Warm Trauma Patients

Primary Purpose

Massive Blood Loss, Hypothermia

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Thermal Blanket

About this trial

This is an interventional device feasibility trial for Massive Blood Loss focused on measuring warming blankets, trauma, bleeding

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sunnybrook Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study blanket

Arm Description

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.

Outcomes

Primary Outcome Measures

Was the blanket applied to the patient?

Binary indication of whether or not the blanket is applied to the patient

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

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)

Secondary Outcome Measures

Was the blanket placed directly on the patients skin?

Number of times blanket is placed directly on the skin

Cold Discomfort Questionnaire

Assess cold discomfort of the patient during resuscitation (min value=0 [warm], max value=10 [unbearably cold])

Did the patients temperature exceed 38 degrees Celsius?

Binary outcome of whether patient temperature exceeded 38 degrees Celsius throughout phases of care

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

Full Information

NCT ID

NCT04399902

First Posted

March 30, 2020

Last Updated

April 16, 2021

Sponsor

Sunnybrook Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT04399902

Brief Title

Study to Actively Warm Trauma Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2021

Overall Recruitment Status

Completed

Study Start Date

October 5, 2020 (Actual)

Primary Completion Date

April 1, 2021 (Actual)

Study Completion Date

April 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sunnybrook Health Sciences Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Massive Blood Loss, Hypothermia

Keywords

warming blankets, trauma, bleeding

7. Study Design

Primary Purpose

Device Feasibility

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Study blanket

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Thermal Blanket

Intervention Description

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.

Primary Outcome Measure Information:

Title

Was the blanket applied to the patient?

Description

Binary indication of whether or not the blanket is applied to the patient

Time Frame

Through study completion, an average of 24 hours

Title

Were patient temperatures recorded?

Description

Time Frame

Through study completion, an average of 24 hours

Title

Did the blanket remain on the patient?

Description

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)

Time Frame

Through study completion, an average of 24 hours

Secondary Outcome Measure Information:

Title

Was the blanket placed directly on the patients skin?

Description

Number of times blanket is placed directly on the skin

Time Frame

Through study completion, an average of 24 hours

Title

Cold Discomfort Questionnaire

Description

Assess cold discomfort of the patient during resuscitation (min value=0 [warm], max value=10 [unbearably cold])

Time Frame

Up to 2 weeks

Title

Did the patients temperature exceed 38 degrees Celsius?

Description

Binary outcome of whether patient temperature exceeded 38 degrees Celsius throughout phases of care

Time Frame

Through study completion, an average of 24 hours

Title

Did the patient experience any redness and/or burns?

Description

Number of times redness and/or burns are reported by the patient and/or treating clinician

Time Frame

Through study completion, an average of 24 hours

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Luis T da Luz, MD, MSc

Organizational Affiliation

Sunnybrook Health Sciences Centre

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sunnybrook Health Sciences Centre

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M4N 3M5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

IPD will not be shared with other researchers

Learn more about this trial

Study to Actively Warm Trauma Patients

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