Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming
Primary Purpose
Hypothermia
Status
Completed
Phase
Phase 3
Locations
Austria
Study Type
Interventional
Intervention
Patient Warming with Forced Air
Resistive Warming
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia focused on measuring Perioperative Hypothermia Prevention, Accidental Perioperative Hypothermia
Eligibility Criteria
Inclusion Criteria:
- The investigators will study 40 patients (18-90 years) undergoing elective orthopedic lower limb surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 2 - 3 hours.
Exclusion Criteria:
- There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.
Sites / Locations
- Oliver Kimberger
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Forced air
Resistive HotDog Warming
Arm Description
Forced Air Warming
Warming by resistive Warming
Outcomes
Primary Outcome Measures
Core Temperature at the end of surgery (at time of skin suture)
Secondary Outcome Measures
Core temperature increase (°C/time)
Full Information
NCT ID
NCT01075724
First Posted
January 25, 2010
Last Updated
January 14, 2015
Sponsor
Medical University of Vienna
1. Study Identification
Unique Protocol Identification Number
NCT01075724
Brief Title
Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming
Official Title
Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming During Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Vienna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Intraoperative active warming is usually performed by skin warming. There are several forced-air systems on the market; forced air warming is generally described as the most effective yet feasible method of patient warming.
Augustine Biomedical (Eden Prairie, MN, USA) recently introduced a new patient warming system named "Hot Dog" with an active polymer warming upper-body blanket and a new under-body warming mattress. The polymer-heating devices consist of an electronic regulator and the polymer blankets, which are covered with a washable fabric. Conventional mains power the system. The manufacturer claims, that the new system "Hot Dog" (with combination of under body and upper body warming) is as effective as forced air warming, while not having any disadvantages of the forced air system, like: airborne infection, noise, high power consumption and hard-to-clean hose.
The investigators will compare the new Hot Dog patient warming device combination (under body + upper body) with the established warming system, which blows warm air via a mattress over the body of the patients).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
Perioperative Hypothermia Prevention, Accidental Perioperative Hypothermia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Forced air
Arm Type
Active Comparator
Arm Description
Forced Air Warming
Arm Title
Resistive HotDog Warming
Arm Type
Experimental
Arm Description
Warming by resistive Warming
Intervention Type
Device
Intervention Name(s)
Patient Warming with Forced Air
Intervention Description
Forced Air warming via BairHugger
Intervention Type
Device
Intervention Name(s)
Resistive Warming
Intervention Description
Resistive Warming via HotDog device
Primary Outcome Measure Information:
Title
Core Temperature at the end of surgery (at time of skin suture)
Time Frame
Single Measurement at Beginning of Skin Suture
Secondary Outcome Measure Information:
Title
Core temperature increase (°C/time)
Time Frame
From Beginning until End of Surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The investigators will study 40 patients (18-90 years) undergoing elective orthopedic lower limb surgery at the trauma surgery unit. The patients must have normal weight (20-30 BMI), the duration of surgery should last between 2 - 3 hours.
Exclusion Criteria:
There will be no other exclusion criteria (except severe peripheral arterial disease in the warmed extremity), as forced air patient warming is routinely used for all patients during this procedure.
Facility Information:
Facility Name
Oliver Kimberger
City
Vienna
ZIP/Postal Code
1090
Country
Austria
12. IPD Sharing Statement
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Comparison of a New Patient Warming System Using a Polymer Conductive Warming Under-body and Upper-body Blanket With Forced Air Warming
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