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OpenTrials
Completed

NCT Number: NCT03408197

Two Warming Methods in Knee Arthroplasty

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.

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Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tampere University Hospital

Tampere, 3351, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Easywarm

Device

Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia

BairHugger

Device

Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia

Primary outcomes

  1. Core temperature after arriving to the post-anaesthesia care unit

    Time frame: one hour

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Jan 23, 2018
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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