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NCT02467777 Clinical Trial

Comparison of Forced Air and Conductive Patient Heating Systems During Ambulatory Surgeries

Hypothermia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02467777
Other study ID # 15-025
Secondary ID
Status Completed
Phase N/A
First received April 23, 2015
Last updated July 22, 2015
Start date June 2015
Est. completion date July 2015

Study information
Verified date July 2015
Source Fox Valley Orthopedic Institute
Contact n/a
Is FDA regulated No
Health authority USA: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Comparison of forced air and conductive warming devices in outpatient orthopaedic surgeries.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2015
Est. primary completion date July 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients undergoing orthopaedic outpatient surgeries over 18 years old

Exclusion Criteria:

- allergic to material of bair hugger

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Bair Hugger

• VitaHeat

Locations
Country Name City State
United States Fox Valley Orthopedics Geneva Illinois

Sponsors (1)
Lead Sponsor Collaborator
Fox Valley Orthopedic Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Temperature Measured by temporal artery thermometer during surgery No
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