Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket

Not Applicable

Completed

• Conditions: Hypothermia; Trauma
• Interventions: Device: ReadyHeat® blanket; Device: Cotton wool blanket

• Registration Number: NCT02353793
• Lead Sponsor: University Hospital Schleswig-Holstein

Brief Summary

Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.

Detailed Description

Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming (via an exothermic reaction) ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia. Near body core temperature is measured by a sublingual sensor as the "gold standard" of body core temperature measurement - the pulmonary artery catheter - is too invasive and not suited for this collective of patients in the emergency room setting. Blanket use will be randomized. Temperature will be taken at emergency room admission, after 15, 30 and 45 minutes of treatment as well as right before handing the patient over to the next caring unit (ICU, IMC, operating theatre etc.). If treatment time is shorter than expected measurement will stop at the latest possible point. Blankets will be applied to the patient once admission in the emergency room is complete and will only be lifted for interventions.

Study Timeline

• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2015-02-02
• Study First Posted: 2015-02-03
• Study Start: 2015-04
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-26
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Trauma patients ≥ 18 years of all severity stages including poly traumatized patients admissioned through the emergency room

Exclusion Criteria

• Patients < 18 years
• Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ReadyHeat® blanket	ReadyHeat® blanket	Patient warming with ReadyHeat® blanket
Cotton wool blanket	Cotton wool blanket	Patient warming with cotton wool blanket

Primary Outcome Measures

Name	Time	Method
Body core temperature at the end of completed emergency room treatment	When handing the patient over to the next caring unit (ICU, operating theatre etc.) n most cases an average time frame < 60 min is maintained	Body core temperature taken after completed emergency room treatment incl. imaging. In most cases an average time frame \< 60 min is maintained.

Secondary Outcome Measures

Name	Time	Method
Body core temperature during emergency room treatment	Temperature measurement: Admission, after 15, 30, 45 minutes	Body core temperature taken after emergency room admission and 15, 30 and 45 minutes after beginning of treatment

Trial Locations

Locations (1)

University Hospital Schleswig-Holstein, Campus Kiel; 🇩🇪 Kiel, Schleswig-Holstein, Germany