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

Primary Purpose

Perioperative Hypothermia

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Bair-Paws Warming Device
Bair-Hugger Warming Device
Sponsored by
University of Wisconsin, Madison
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Perioperative Hypothermia

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • University of Wisconsin School of Medicine and Public Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pre-Warming

Control

Arm Description

Outcomes

Primary Outcome Measures

Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.

Secondary Outcome Measures

Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.
Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.
Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.
Incidence of Postoperative Shivering in Recovery Room.
Intraoperative Blood Loss.
Intraoperative blood loss in mL's.
Incidence of Perioperative Cardiac Events.
Incidence of perioperative arrhythmias or myocardial ischemia.
Temporal Artery Verus SpotOn (3M) Temperature Readings.
Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.

Full Information

First Posted
June 12, 2012
Last Updated
July 20, 2016
Sponsor
University of Wisconsin, Madison
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1. Study Identification

Unique Protocol Identification Number
NCT01626690
Brief Title
Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
Official Title
Prospective Randomized Control Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Terminated
Why Stopped
Surgeons change in preference for perioperative warming.
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Perioperative Hypothermia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pre-Warming
Arm Type
Experimental
Arm Title
Control
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Bair-Paws Warming Device
Intervention Description
Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
Intervention Type
Device
Intervention Name(s)
Bair-Hugger Warming Device
Intervention Description
Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
Primary Outcome Measure Information:
Title
Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
Description
Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.
Time Frame
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Secondary Outcome Measure Information:
Title
Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.
Time Frame
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Title
Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.
Time Frame
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Title
Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.
Time Frame
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Title
Incidence of Postoperative Shivering in Recovery Room.
Time Frame
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Title
Intraoperative Blood Loss.
Description
Intraoperative blood loss in mL's.
Time Frame
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Title
Incidence of Perioperative Cardiac Events.
Description
Incidence of perioperative arrhythmias or myocardial ischemia.
Time Frame
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).
Title
Temporal Artery Verus SpotOn (3M) Temperature Readings.
Description
Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.
Time Frame
The treatment period starts with the patient consenting to the study and application of preoperative forced-air warming device and ends when the patient leaves the PACU (average 4-8 hours following enrollment).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Facility Information:
Facility Name
University of Wisconsin School of Medicine and Public Health
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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

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