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Two Warming Methods in Knee Arthroplasty

NCT03408197 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2021-01-22

No results posted yet for this study

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.

Conditions

  • Hypothermia, Accidental

Interventions

DEVICE

EasyWarm

Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia

DEVICE

BairHugger

Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia

Sponsors & Collaborators

  • Tampere University Hospital

    lead OTHER

Principal Investigators

  • Maija-Liisa Kalliomäki · Tampere University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2019-11-11
Completion
2020-05-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03408197 on ClinicalTrials.gov