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

Phase 4

Terminated

• Conditions: Perioperative Hypothermia
• Interventions: Device: Bair-Paws Warming Device; Device: Bair-Hugger Warming Device

• Registration Number: NCT01626690
• Lead Sponsor: University of Wisconsin, Madison

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 available

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-06-12
• Study First Submitted QC: 2012-06-22
• Study First Posted: 2012-06-25
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2016-01-21
• Status Verified: 2016-07
• Results First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-20
• Results First Posted: 2016-08-15
• Last Update Posted: 2016-08-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 100

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pre-Warming	Bair-Paws Warming Device	-
Control	Bair-Hugger Warming Device	-

Primary Outcome Measures

Name	Time	Method
Patient Temperature at the Time of 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).	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

Name	Time	Method
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).	Intraoperative blood loss in mL's.
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).	Incidence of perioperative arrhythmias or myocardial ischemia.
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).	Temperature with temporal artery thermometer and SpotOn temperature monitoring device (3M) at time of incision.
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).

Trial Locations

Locations (1)

University of Wisconsin School of Medicine and Public Health; 🇺🇸 Madison, Wisconsin, United States