Two Warming Methods in Knee Arthroplasty

NCT03408197 | Completed

• 1 other identifier: R17136
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypothermia, Accidental

Keywords

inadvertent, intraoperative hypothermia, prewarming; core temperature monitoring

Outcome Measures

Primary Outcomes (1)

• Core temperature after arriving to the post-anaesthesia care unit

  one hour

Study Arms (2)

EasyWarm

EXPERIMENTAL

Device: EasyWarm

BairHugger

ACTIVE COMPARATOR

Device: BairHugger

Interventions

EasyWarm DEVICE

Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia

EasyWarm

BairHugger DEVICE

Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia

BairHugger

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI 25-40
• ASA class I-III
• elective primary unilateral kneearthroplasty
• spinal anaesthesia

You may not qualify if:

• ASA class \> III
• unstable coronary artery disease
• revision surgery, bilateral arthroplasty
• general anaesthesia
• decreased mental status

Sponsors & Collaborators

• Tampere University Hospital: lead

Study Sites (1)

Tampere University Hospital

Tampere, 3351, Finland

Location

Related Publications (2)

• Lauronen SL, Kalliovalkama J, Aho A, Makinen MT, Huhtala H, Yli-Hankala AM, Kalliomaki ML. Self-warming blanket versus forced-air warming blanket during total knee arthroplasty under spinal anaesthesia: A randomised non-inferiority trial. Acta Anaesthesiol Scand. 2023 Sep;67(8):1102-1109. doi: 10.1111/aas.14283. Epub 2023 May 28.

  PMID: 37246242 DERIVED

• 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.

  PMID: 34978656 DERIVED

MeSH Terms

Conditions

Hypothermia

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maija-Liisa Kalliomäki

  Tampere University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: January 23, 2018
• Study Start: November 19, 2018
• Primary Completion: November 11, 2019
• Study Completion: May 31, 2020
• Last Updated: January 22, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)