NCT03408197

Two Warming Methods in Knee Arthroplasty

Completed NA Last updated 22 January 2021

What this trial tests

NA trial testing EasyWarm in Hypothermia, Accidental in 150 participants. Completed in 31 May 2020.

Timeline

19 November 2018

Primary endpoint
11 November 2019

31 May 2020

Quick facts

Lead sponsor	Tampere University Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	150
Start date	19 November 2018
Primary completion	11 November 2019
Estimated completion	31 May 2020
Sites	1 location across Finland

Drugs / interventions tested

• EasyWarm
• BairHugger

Conditions studied

• Hypothermia, Accidental — all drugs for Hypothermia, Accidental →

Sponsor

Tampere University Hospital

Who can join

Adults 40 to 90, any sex, with Hypothermia, Accidental. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comparison of zero heat flux and double sensor thermometers during spinal anaesthesia: a prospective observational study.
   Lauronen SL, Kalliomäki ML, Kalliovalkama J, Aho A, et al · · 2022 · cited 4× · PMID 34978656 · DOI 10.1007/s10877-021-00799-6
2. Self-warming blanket versus forced-air warming blanket during total knee arthroplasty under spinal anaesthesia: A randomised non-inferiority trial.
   Lauronen SL, Kalliovalkama J, Aho A, Mäkinen MT, et al · · 2023 · cited 1× · PMID 37246242 · DOI 10.1111/aas.14283