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

Overview

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.

Full Title of Study: “Trauma Patients and Hypothermia in the Emergency Room: a Trial Between Self-warming ReadyHeat® Blanket and Traditional Cotton Wool Blanket”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 2016

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.

Interventions

  • Device: ReadyHeat® blanket
    • Using ReadyHeat® blanket for patient warming
  • Device: Cotton wool blanket
    • Using cotton wool blanket for patient warming

Arms, Groups and Cohorts

  • Experimental: ReadyHeat® blanket
    • Patient warming with ReadyHeat® blanket
  • Active Comparator: Cotton wool blanket
    • Patient warming with cotton wool blanket

Clinical Trial Outcome Measures

Primary Measures

  • Body core temperature at the end of completed emergency room treatment
    • Time Frame: 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 Measures

  • Body core temperature during emergency room treatment
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital Schleswig-Holstein
  • Provider of Information About this Clinical Study
    • Principal Investigator: Timo Iden, M.D. – University Hospital Schleswig-Holstein
  • Overall Official(s)
    • Jan Höcker, M.D., Study Director, Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel

References

Curry N, Davis PW. What's new in resuscitation strategies for the patient with multiple trauma? Injury. 2012 Jul;43(7):1021-8. doi: 10.1016/j.injury.2012.03.014. Epub 2012 Apr 7.

Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.

Kapan M, Onder A, Oguz A, Taskesen F, Aliosmanoglu I, Gul M, Tacyildiz I. The effective risk factors on mortality in patients undergoing damage control surgery. Eur Rev Med Pharmacol Sci. 2013 Jun;17(12):1681-7.

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