Two Warming Methods in Knee Arthroplasty

Hypothermia, Accidental Clinical Trial

Official title:

Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408197
• Other study ID #: R17136
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: January 2021
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: May 31, 2020
• Est. primary completion date: November 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypothermia
• Hypothermia, Accidental

Intervention

Device:
• EasyWarm
Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia
• BairHugger
Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Core temperature after arriving to the post-anaesthesia care unit		one hour