Two Warming Methods in Knee Arthroplasty

NCT ID: NCT03408197

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2020-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hypothermia, Accidental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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EasyWarm

Group Type EXPERIMENTAL

EasyWarm

Intervention Type DEVICE

Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia

BairHugger

Group Type ACTIVE_COMPARATOR

BairHugger

Intervention Type DEVICE

Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia

Interventions

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EasyWarm

Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia

Intervention Type DEVICE

BairHugger

Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maija-Liisa Kalliomäki

Role: STUDY_DIRECTOR

Tampere University Hospital

Locations

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Tampere University Hospital

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type DERIVED
PMID: 37246242 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34978656 (View on PubMed)

Other Identifiers

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R17136

Identifier Type: -

Identifier Source: org_study_id

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