Two Warming Methods in Knee Arthroplasty

January 21, 2021 updated by: Tampere University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 3351
        • Tampere university Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: EasyWarm
Device: EasyWarm
Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia
ACTIVE_COMPARATOR: BairHugger
Device: BairHugger
Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Core temperature after arriving to the post-anaesthesia care unit
Time Frame: one hour
one hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Study Director: Maija-Liisa Kalliomäki, Tampere university Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 19, 2018

Primary Completion (ACTUAL)

November 11, 2019

Study Completion (ACTUAL)

May 31, 2020

Study Registration Dates

First Submitted

January 17, 2018

First Submitted That Met QC Criteria

January 17, 2018

First Posted (ACTUAL)

January 23, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 21, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R17136

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypothermia, Accidental

Clinical Trials on EasyWarm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe