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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Kristopher Schroeder, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01626690
First received: June 12, 2012
Last updated: March 8, 2013
Last verified: March 2013
  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: 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:
  • Temporal artery temperature at the 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). ] [ Designated as safety issue: Yes ]
    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:
  • Temporal artery temperature before entering 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). ] [ Designated as safety issue: No ]
  • Temporal artery temperature every 30 minutes in operating 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). ] [ Designated as safety issue: Yes ]
  • Temporal artery temperature on arrival to 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). ] [ Designated as safety issue: Yes ]
  • 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). ] [ Designated as safety issue: Yes ]
  • 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). ] [ Designated as safety issue: Yes ]
    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). ] [ Designated as safety issue: Yes ]
    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). ] [ Designated as safety issue: No ]
    At each temperature measurement interval, will record temperature with both temporal artery thermometer and SpotOn temperature monitoring device (3M).


Estimated Enrollment: 120
Study Start Date: May 2012
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Kristopher Schroeder, Assistant Professor, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01626690     History of Changes
Other Study ID Numbers: 2011-0823
Study First Received: June 12, 2012
Last Updated: March 8, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 20, 2014