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

University of Wisconsin, Madison1 site in 1 country100 target enrollmentMay 2012

ConditionsPerioperative Hypothermia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Perioperative Hypothermia
Sponsor: University of Wisconsin, Madison
Enrollment: 100
Locations: 1
Primary Endpoint: Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
Status: Terminated
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

December 2014

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Wisconsin, Madison

Responsible Party

Sponsor

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).

Outcomes

Primary Outcomes

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 Outcomes

Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.(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 Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.(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.(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 Cardiac Events.(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 Verus SpotOn (3M) Temperature Readings.(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.(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.(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).)