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Two Warming Methods in Knee Arthroplasty

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ClinicalTrials.gov Identifier: NCT03408197
Recruitment Status : Not yet recruiting
First Posted : January 23, 2018
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

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.

Condition or disease Intervention/treatment Phase
Hypothermia, Accidental Device: EasyWarm Device: BairHugger Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : January 15, 2019
Estimated Study Completion Date : January 15, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Core temperature after arriving to the post-anaesthesia care unit [ Time Frame: one hour ]


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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03408197


Contacts
Contact: Sirkka-Liisa Lauronen +358444858163 sirkka-liisa.lauronen@pshp.fi
Contact: Simo Varila +358331165063 simo.varila@pshp.fi

Sponsors and Collaborators
Tampere University Hospital
Investigators
Study Director: Maija-Liisa Kalliomäki Tampere University Hospital

Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03408197     History of Changes
Other Study ID Numbers: R17136
First Posted: January 23, 2018    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
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

Additional relevant MeSH terms:
Hypothermia
Body Temperature Changes
Signs and Symptoms