Skip to content

Two Warming Methods in Knee Arthroplasty

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03408197
Enrollment
150
Registered
2018-01-23
Start date
2018-11-19
Completion date
2020-05-31
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypothermia, Accidental

Keywords

inadvertent, intraoperative hypothermia, prewarming, core temperature monitoring

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.

Interventions

DEVICEEasyWarm

Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia

Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
40 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Core temperature after arriving to the post-anaesthesia care unitone hour

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026