ClinicalTrials.Veeva

Menu

Two Warming Methods in Knee Arthroplasty

T

Tampere University Hospital

Status

Completed

Conditions

Hypothermia, Accidental

Treatments

Device: BairHugger
Device: EasyWarm

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

150 participants in 2 patient groups

EasyWarm
Experimental group
Treatment:
Device: EasyWarm
BairHugger
Active Comparator group
Treatment:
Device: BairHugger

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems