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

Sponsor
University Hospital Schleswig-Holstein (Other)
Overall Status
Completed
CT.gov ID
NCT02353793
Collaborator
(none)
60
1
2
17.1
3.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: ReadyHeat® blanket
  • Device: Cotton wool blanket
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Trauma Patients and Hypothermia in the Emergency Room: a Trial Between Self-warming ReadyHeat® Blanket and Traditional Cotton Wool Blanket
Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Sep 1, 2016
Actual Study Completion Date :
Sep 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: ReadyHeat® blanket

Patient warming with ReadyHeat® blanket

Device: ReadyHeat® blanket
Using ReadyHeat® blanket for patient warming

Active Comparator: Cotton wool blanket

Patient warming with cotton wool blanket

Device: Cotton wool blanket
Using cotton wool blanket for patient warming

Outcome Measures

Primary Outcome Measures

  1. Body core temperature at the end of completed emergency room treatment [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 Outcome Measures

  1. Body core temperature during emergency room treatment [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital Schleswig-Holstein, Campus Kiel Kiel Schleswig-Holstein Germany 24105

Sponsors and Collaborators

  • University Hospital Schleswig-Holstein

Investigators

  • Study Director: Jan Höcker, M.D., Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Timo Iden, M.D., University Hospital Schleswig-Holstein
ClinicalTrials.gov Identifier:
NCT02353793
Other Study ID Numbers:
  • ReadyHeat
First Posted:
Feb 3, 2015
Last Update Posted:
Nov 29, 2016
Last Verified:
Nov 1, 2016
Keywords provided by Timo Iden, M.D., University Hospital Schleswig-Holstein
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 29, 2016