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

History of Changes

Tracking Information
First Received Date ^ICMJE	June 12, 2012
Last Updated Date	March 8, 2013
Start Date ^ICMJE	May 2012
Estimated Primary Completion Date	May 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: June 22, 2012)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01626690 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 8, 2013)	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).
Original Secondary Outcome Measures ^ICMJE (submitted: June 22, 2012)	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.
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
Official Title ^ICMJE	Prospective Randomized Control Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Perioperative Hypothermia
Intervention ^ICMJE	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).
Study Arm (s)	Experimental: Pre-Warming Intervention: Device: Bair-Paws Warming Device Active Comparator: Control Intervention: Device: Bair-Hugger Warming Device
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	120
Completion Date	Not Provided
Estimated Primary Completion Date	May 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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).
Gender	Both
Ages	55 Years to 85 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01626690
Other Study ID Numbers ^ICMJE	2011-0823
Has Data Monitoring Committee	Not Provided
Responsible Party	Kristopher Schroeder, University of Wisconsin, Madison
Study Sponsor ^ICMJE	University of Wisconsin, Madison
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	University of Wisconsin, Madison
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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