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

NCT01626690 | Terminated Phase 4 Results

• 1 other identifier: 2011-0823
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Perioperative Hypothermia

Outcome Measures

Primary Outcomes (1)

• Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..

  Temporal artery temperature readings (in degrees celsius) will be obtained at the time of incision and every 30 minutes while in the OR.

  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).

Secondary Outcomes (7)

• 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).

• 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).

• 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).

• 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).

• 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).

Study Arms (2)

Pre-Warming

EXPERIMENTAL

Device: Bair-Paws Warming Device

Control

ACTIVE COMPARATOR

Device: Bair-Hugger Warming Device

Interventions

Bair-Paws Warming Device DEVICE

Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.

Pre-Warming

Bair-Hugger Warming Device DEVICE

Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).

Control

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing total hip arthroplasty under neuraxial anesthesia,
• age 55-85,
• BMI 18-40

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Results Point of Contact

• Title: Dr. Kristopher Schroeder, MD
• Organization: University of Wisconsin School of Medicine and Public Health

kmschro1@wisc.edu

608-263-8100

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2012
• First Posted: June 25, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 15, 2016
• Results First Posted: August 15, 2016

Record last verified: 2016-07

Locations

US (1)