Clinical trial NCT01626690: Prospective Trial of the Effect of Preoperative Forced-air Warming on Perioperative Body Temperature Following Neuraxial Anesthesia in Total Hip Arthroplasty Patients
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Perioperative Hypothermia
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Patient Temperature at the Time of Incision as Measured by SpotOn (3M) Temperature Monitoring System..
timeFrame: 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:
measure: Patient Temperature Prior to Entering OR as Measured by SpotOn (3M) Temperature Monitoring System.
timeFrame: 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).
measure: Patient Temperature 30 Minutes Following Incision as Measured by SpotOn (3M) Temperature Monitoring System.
timeFrame: 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).
measure: Patient Temperature on Arrival to Recovery Room as Measured by SpotOn (3M) Temperature Monitoring System.
timeFrame: 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).
measure: Incidence of Postoperative Shivering in Recovery Room.
timeFrame: 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).
measure: Intraoperative Blood Loss.
timeFrame: 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).
measure: Incidence of Perioperative Cardiac Events.
timeFrame: 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).
measure: Temporal Artery Verus SpotOn (3M) Temperature Readings.
timeFrame: 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).
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
References: