Two Warming Methods in Knee Arthroplasty
Primary Purpose
Hypothermia, Accidental
Status
Completed
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
EasyWarm
BairHugger
Sponsored by
About this trial
This is an interventional prevention trial for Hypothermia, Accidental focused on measuring inadvertent, intraoperative hypothermia, prewarming, core temperature monitoring
Eligibility Criteria
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
Sites / Locations
- Tampere University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EasyWarm
BairHugger
Arm Description
Outcomes
Primary Outcome Measures
Core temperature after arriving to the post-anaesthesia care unit
Secondary Outcome Measures
Full Information
NCT ID
NCT03408197
First Posted
January 17, 2018
Last Updated
January 21, 2021
Sponsor
Tampere University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03408197
Brief Title
Two Warming Methods in Knee Arthroplasty
Official Title
Comparison of Two Warming Methods in Knee Arthroplasty. A Prospective, Randomized Non-inferiority Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
November 11, 2019 (Actual)
Study Completion Date
May 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothermia, Accidental
Keywords
inadvertent, intraoperative hypothermia, prewarming, core temperature monitoring
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EasyWarm
Arm Type
Experimental
Arm Title
BairHugger
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
EasyWarm
Intervention Description
Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia
Intervention Type
Device
Intervention Name(s)
BairHugger
Intervention Description
Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia
Primary Outcome Measure Information:
Title
Core temperature after arriving to the post-anaesthesia care unit
Time Frame
one hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maija-Liisa Kalliomäki
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
3351
Country
Finland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34978656
Citation
Lauronen SL, Kalliomaki ML, Kalliovalkama J, Aho A, Huhtala H, Yli-Hankala AM, Makinen MT. Comparison of zero heat flux and double sensor thermometers during spinal anaesthesia: a prospective observational study. J Clin Monit Comput. 2022 Oct;36(5):1547-1555. doi: 10.1007/s10877-021-00799-6. Epub 2022 Jan 3.
Results Reference
derived
Learn more about this trial
Two Warming Methods in Knee Arthroplasty
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