TerminatedPhase 4

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

Stopped: Surgeons change in preference for perioperative warming.

United States100 participantsStarted 2012-05

Plain-language 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.

Who can participate

Age range

55 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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).

Trial details

NCT IDNCT01626690

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-12

Results submitted2016-01-21

View on ClinicalTrials.gov More Perioperative Hypothermia trials