Two Warming Methods in Knee Arthroplasty

Not Applicable

Completed

• Conditions: Hypothermia, Accidental
• Interventions: Device: EasyWarm; Device: BairHugger

• Registration Number: NCT03408197
• Lead Sponsor: Tampere University Hospital

Brief Summary

In this study two warming methods will be compared in knee arthroplasty surgery. Barrier EasyWarm will be used in the study group and BairHugger upper body warming blanket in the control group. Both groups will be prewarmed 30 minutes before spinal anaesthesia. In the operating room warming will be continued with the same warming method. Primary end point is core temperature after arriving to post anaesthesia care unit. Hypothesis is that Barrier EasyWarm is not inferior to BairHugger in preventing inadvertent intraoperative hypothermia.

Few methods exist to measure the core temperature non-invasively. Zero-heat-flux technique is used in this study. During the study we will test the accuracy of the 3M BairHugger Temperature Monitoring System by placing two sensors onto the patients (n = 30) fore head. After that the accuracy of the Dräger Tcore is examined by comparing it with the 3M BairHugger Temperature Monitoring System. So the patients (n=30) have both these different core temperature monitoring systems on their foreheads. This observational monitoring study is performed from the patient number 80 until the end.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-17
• Study First Submitted QC: 2018-01-17
• Study First Posted: 2018-01-23
• Study Start: 2018-11-19
• Primary Completion: 2019-11-11
• Study Completion: 2020-05-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-21
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• BMI 25-40
• ASA class I-III
• elective primary unilateral kneearthroplasty
• spinal anaesthesia

Exclusion Criteria

• ASA class > III
• unstable coronary artery disease
• revision surgery, bilateral arthroplasty
• general anaesthesia
• decreased mental status

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EasyWarm	EasyWarm	-
BairHugger	BairHugger	-

Primary Outcome Measures

Name	Time	Method
Core temperature after arriving to the post-anaesthesia care unit	one hour

Trial Locations

Locations (1)

Tampere University Hospital; 🇫🇮 Tampere, Finland