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

Primary Purpose

Hypothermia, Trauma

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
ReadyHeat® blanket
Cotton wool blanket
Sponsored by
University Hospital Schleswig-Holstein
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring Hypothermia, (Poly) Trauma, Emergency Room, Warming Blanket

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University Hospital Schleswig-Holstein, Campus Kiel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ReadyHeat® blanket

Cotton wool blanket

Arm Description

Patient warming with ReadyHeat® blanket

Patient warming with cotton wool blanket

Outcomes

Primary Outcome Measures

Body core temperature at the end of completed emergency room treatment
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

Body core temperature during emergency room treatment
Body core temperature taken after emergency room admission and 15, 30 and 45 minutes after beginning of treatment

Full Information

First Posted
December 15, 2014
Last Updated
November 26, 2016
Sponsor
University Hospital Schleswig-Holstein
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1. Study Identification

Unique Protocol Identification Number
NCT02353793
Brief Title
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

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
April 2015 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Trauma
Keywords
Hypothermia, (Poly) Trauma, Emergency Room, Warming Blanket

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ReadyHeat® blanket
Arm Type
Experimental
Arm Description
Patient warming with ReadyHeat® blanket
Arm Title
Cotton wool blanket
Arm Type
Active Comparator
Arm Description
Patient warming with cotton wool blanket
Intervention Type
Device
Intervention Name(s)
ReadyHeat® blanket
Intervention Description
Using ReadyHeat® blanket for patient warming
Intervention Type
Device
Intervention Name(s)
Cotton wool blanket
Intervention Description
Using cotton wool blanket for patient warming
Primary Outcome Measure Information:
Title
Body core temperature at the end of completed emergency room treatment
Description
Body core temperature taken after completed emergency room treatment incl. imaging. In most cases an average time frame < 60 min is maintained.
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
Secondary Outcome Measure Information:
Title
Body core temperature during emergency room treatment
Description
Body core temperature taken after emergency room admission and 15, 30 and 45 minutes after beginning of treatment
Time Frame
Temperature measurement: Admission, after 15, 30, 45 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Höcker, M.D.
Organizational Affiliation
Klinik für Anästhesiologie und Operative Intensivmedizin, Arnold-Heller-Str. 3, Haus 12, 24105 Kiel
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Schleswig-Holstein, Campus Kiel
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
22487163
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.
Results Reference
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PubMed Identifier
18648241
Citation
Sessler DI. Temperature monitoring and perioperative thermoregulation. Anesthesiology. 2008 Aug;109(2):318-38. doi: 10.1097/ALN.0b013e31817f6d76.
Results Reference
background
PubMed Identifier
23832738
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.
Results Reference
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Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket

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