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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
Fox Valley Orthopedic Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypothermia focused on measuring orthopaedics, post-operative warming

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
April 23, 2015
Last Updated
April 5, 2017
Sponsor
Fox Valley Orthopedic Institute
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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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