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NCT Number: NCT02353793

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

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.

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Key information

Conditions

Hypothermia Body Temperature Changes Disease Attributes Emergencies Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Trauma Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ReadyHeat® blanket

Device

Using ReadyHeat® blanket for patient warming

Cotton wool blanket

Device

Using cotton wool blanket for patient warming

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Trauma Patients and Hypothermia in the Emergency Room: a Trial Between Self-warming ReadyHeat® Blanket and Traditional Cotton Wool Blanket

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Feb 3, 2015
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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