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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02353793
Enrollment
60
Registered
2015-02-03
Start date
2015-04-30
Completion date
2016-09-30
Last updated
2016-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Trauma

Keywords

Hypothermia, (Poly) Trauma, Emergency Room, Warming Blanket

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.

Interventions

DEVICEReadyHeat® blanket

Using ReadyHeat® blanket for patient warming

DEVICECotton wool blanket

Using cotton wool blanket for patient warming

Sponsors

University Hospital Schleswig-Holstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Body core temperature during emergency room treatmentTemperature measurement: Admission, after 15, 30, 45 minutesBody core temperature taken after emergency room admission and 15, 30 and 45 minutes after beginning of treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026