Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries
Primary Purpose
Hypothermia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Bair Hugger
VitaHeat
Sponsored by
About this trial
This is an interventional treatment trial for Hypothermia focused on measuring orthopaedics, post-operative warming
Eligibility Criteria
Inclusion Criteria:
- patients undergoing orthopaedic outpatient surgeries over 18 years old
Exclusion Criteria:
- allergic to material of bair hugger
Sites / Locations
- Fox Valley Orthopedics
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Forced Air
Conductive Warming
Arm Description
Bair Hugger
VitaHeat
Outcomes
Primary Outcome Measures
Temperature
Measured by temporal artery thermometer
Secondary Outcome Measures
Full Information
NCT ID
NCT02467777
First Posted
April 23, 2015
Last Updated
April 5, 2017
Sponsor
Fox Valley Orthopedic Institute
1. Study Identification
Unique Protocol Identification Number
NCT02467777
Brief Title
Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fox Valley Orthopedic Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.
Detailed Description
Patients will be randomized into either the Forced Air group (FA) or Conductive Heat group (CH). Randomization will be based on computer-generated codes that will be maintained in sequentially numbered opaque envelopes. Fifty patients will be recruited with 25 patients being randomized into each group.
In patients assigned to the FA group, a Bair Hugger (Arizant Medical, Inc., Eden Prairie, Minnesota) forced-air cover will be positioned over the upper body (if lower extremity surgery) or lower body (if upper extremity surgery). The forced-air blower will be set and activated per standard practice usually after prepping and draping.
In patients assigned to the CH group, a VitaHeat (VitaHeat, Inc, Aurora, IL) conductive heating device will be placed under the torso of the patient. The device will be set and activated per standard practice usually just after positioning of the patient on the operating table.
Patients in both groups will be otherwise draped per surgical routine. Ambient temperature will be maintained near 20°C. Temperatures will be recorded using a temporal artery thermometer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia
Keywords
orthopaedics, post-operative warming
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Forced Air
Arm Type
Active Comparator
Arm Description
Bair Hugger
Arm Title
Conductive Warming
Arm Type
Active Comparator
Arm Description
VitaHeat
Intervention Type
Device
Intervention Name(s)
Bair Hugger
Intervention Type
Device
Intervention Name(s)
VitaHeat
Primary Outcome Measure Information:
Title
Temperature
Description
Measured by temporal artery thermometer
Time Frame
Intra-Operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients undergoing orthopaedic outpatient surgeries over 18 years old
Exclusion Criteria:
allergic to material of bair hugger
Facility Information:
Facility Name
Fox Valley Orthopedics
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
12. IPD Sharing Statement
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Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries
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