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

U

University Hospital Schleswig-Holstein (UKSH)

Status

Completed

Conditions

Trauma
Hypothermia

Treatments

Device: ReadyHeat® blanket
Device: Cotton wool blanket

Study type

Interventional

Funder types

Other

Identifiers

NCT02353793
ReadyHeat

Details and patient eligibility

About

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 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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 2 patient groups

ReadyHeat® blanket
Experimental group
Description:
Patient warming with ReadyHeat® blanket
Treatment:
Device: ReadyHeat® blanket
Cotton wool blanket
Active Comparator group
Description:
Patient warming with cotton wool blanket
Treatment:
Device: Cotton wool blanket

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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