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

NCT ID: NCT02467777

Last Updated: 2017-05-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2015-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Forced Air

Bair Hugger

Group Type ACTIVE_COMPARATOR

Bair Hugger

Intervention Type DEVICE

Conductive Warming

VitaHeat

Group Type ACTIVE_COMPARATOR

VitaHeat

Intervention Type DEVICE

Interventions

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Bair Hugger

Intervention Type DEVICE

VitaHeat

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing orthopaedic outpatient surgeries over 18 years old

Exclusion Criteria

* allergic to material of bair hugger
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fox Valley Orthopedic Institute

OTHER

Sponsor Role lead

Responsible Party

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Vishal Mehta

Orthopaedic Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fox Valley Orthopedics

Geneva, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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15-025

Identifier Type: -

Identifier Source: org_study_id

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