Clinical trial NCT02353793: Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket
Official title: Trauma Patients and Hypothermia in the Emergency Room: a Trial Between Self-warming ReadyHeat® Blanket and Traditional Cotton Wool Blanket
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypothermia
Trauma
Keywords: Hypothermia
(Poly) Trauma
Emergency Room
Warming Blanket
Lead sponsor: University Hospital Schleswig-Holstein
Sponsor class: OTHER
First posted: 2015-02-03
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Body core temperature at the end of completed emergency room treatment
timeFrame: 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
Secondary outcomes:
measure: Body core temperature during emergency room treatment
timeFrame: Temperature measurement: Admission, after 15, 30, 45 minutes
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Campus Kiel
state: Schleswig-Holstein
Study officials:
affiliation: Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel
name: Jan Höcker, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
citation: 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.