Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients

NCT ID: NCT01626690

Last Updated: 2016-08-15

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

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2014-12-31

Brief Summary

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The purpose of this study is to determine if placement of a forced-air warming device prior to institution of regional anesthesia improves perioperative temperature control in patients undergoing total hip arthroplasty.

Detailed Description

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Conditions

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Perioperative 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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Pre-Warming

Group Type EXPERIMENTAL

Bair-Paws Warming Device

Intervention Type DEVICE

Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.

Control

Group Type ACTIVE_COMPARATOR

Bair-Hugger Warming Device

Intervention Type DEVICE

Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).

Interventions

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Bair-Paws Warming Device

Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.

Intervention Type DEVICE

Bair-Hugger Warming Device

Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients undergoing total hip arthroplasty under neuraxial anesthesia,
* age 55-85,
* BMI 18-40

Exclusion Criteria

* allergy to local anesthetics,
* patients electing to have general anesthesia for their total hip arthroplasty,
* pregnancy,
* prisoners,
* patients unable to give informed consent,
* English as a second language,
* active infectious or febrile illness (measured temperature \> 37.5 degrees Celsius).
Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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2011-0823

Identifier Type: -

Identifier Source: org_study_id

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