Study to Actively Warm Trauma Patients

Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04399902
• Other study ID #: STAY WARM Trial
• Status: Completed
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: April 1, 2021

Study information

• Verified date: April 2021
• Source: Sunnybrook Health Sciences Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 1, 2021
• Est. primary completion date: April 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypothermia
• Massive Blood Loss

Intervention

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.

Locations

Country	Name	City	State
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	Cold Discomfort Questionnaire	Assess cold discomfort of the patient during resuscitation (min value=0 [warm], max value=10 [unbearably cold])	Up to 2 weeks
Secondary	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
Secondary	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