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Two Warming Methods in Knee Arthroplasty

Sponsor
Tampere University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03408197
Collaborator
(none)
150
Enrollment
1
Location
2
Arms
18.4
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: EasyWarm
  • Device: BairHugger
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
150 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.
Actual Study Start Date :
Nov 19, 2018
Actual Primary Completion Date :
Nov 11, 2019
Actual Study Completion Date :
May 31, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Core temperature after arriving to the post-anaesthesia care unit [one hour]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 90 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tampere University Hospital Tampere Finland 3351

Sponsors and Collaborators

  • Tampere University Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tampere University Hospital
ClinicalTrials.gov Identifier:
NCT03408197
Other Study ID Numbers:
  • R17136
First Posted:
Jan 23, 2018
Last Update Posted:
Jan 22, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tampere University Hospital
inadvertent, intraoperative hypothermia, prewarming
core temperature monitoring
Additional relevant MeSH terms:
Hypothermia

Study Results

No Results Posted as of Jan 22, 2021