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

Perioperative Hypothermia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01626690
• Other study ID #: 2011-0823
• Status: Terminated
• Phase: Phase 4
• First received: June 12, 2012
• Last updated: October 1, 2015
• Start date: May 2012
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypothermia
• Perioperative Hypothermia

Intervention

Device:
• Bair-Paws Warming Device
Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
• Bair-Hugger Warming Device
Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).

Locations

Country	Name	City	State
United States	University of Wisconsin School of Medicine and Public Health	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Temporal artery temperature at the time of incision.	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).	Yes
Secondary	Temporal artery temperature before entering 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).	No
Secondary	Temporal artery temperature every 30 minutes in operating 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).	Yes
Secondary	Temporal artery temperature on arrival to 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).	Yes
Secondary	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).	Yes
Secondary	Intraoperative blood loss.	Intraoperative blood loss in mL's.	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).	Yes
Secondary	Incidence of perioperative cardiac events.	Incidence of perioperative arrhythmias or myocardial ischemia.	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).	Yes
Secondary	Temporal artery verus SpotOn (3M) Temperature Readings.	At each temperature measurement interval, will record temperature with both temporal artery thermometer and SpotOn temperature monitoring device (3M).	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).	No