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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

This study has been terminated.
(Surgeons change in preference for perioperative warming.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626690
First Posted: June 25, 2012
Last Update Posted: August 15, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  Purpose
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.

Condition Intervention Phase
Perioperative Hypothermia Device: Bair-Paws Warming Device Device: Bair-Hugger Warming Device Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Patient Temperature at the Time of 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). ]
    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. [ 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). ]
  • 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). ]
  • 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). ]
  • 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). ]
  • Intraoperative Blood Loss. [ 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). ]
    Intraoperative blood loss in mL's.

  • Incidence of Perioperative Cardiac Events. [ 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). ]
    Incidence of perioperative arrhythmias or myocardial ischemia.

  • Temporal Artery Verus SpotOn (3M) Temperature Readings. [ 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). ]
    Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.


Enrollment: 100
Study Start Date: May 2012
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pre-Warming Device: Bair-Paws Warming Device
Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
Active Comparator: Control 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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626690


Locations
United States, Wisconsin
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01626690     History of Changes
Other Study ID Numbers: 2011-0823
First Submitted: June 12, 2012
First Posted: June 25, 2012
Results First Submitted: January 21, 2016
Results First Posted: August 15, 2016
Last Update Posted: August 15, 2016
Last Verified: July 2016

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms