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

June 12, 2012
March 8, 2013
May 2012
May 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01626690 on ClinicalTrials.gov Archive Site
  • 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).
  • 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.
Not Provided
Not Provided
 
Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
Prospective Randomized Control Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Perioperative Hypothermia
  • Device: Bair-Paws Warming Device
    Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
  • 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).
  • Experimental: Pre-Warming
    Intervention: Device: Bair-Paws Warming Device
  • Active Comparator: Control
    Intervention: Device: Bair-Hugger Warming Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
Not Provided
May 2014   (final data collection date for primary outcome measure)

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).
Both
55 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01626690
2011-0823
Not Provided
Kristopher Schroeder, University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Not Provided
University of Wisconsin, Madison
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP