A new hybrid protocol enabling to evaluate the pressure level of medical compression stocking in patients: "ex-vivo procedures"

Abstract

Introduction Medical compression treatment using stockings exerts a pressure to the vascular system which represents the therapeutic dose. This pressure is indirectly measured according to heavy laboratory tests based on calibrated artificial leg markings. The objectives of this work were to elaborate and test a new dynamometer which allows direct measurement of pressure from how the stocking is applied by the patient and whatever the leg curvature radius are. Method A portable mini dynamometer (Modyn) that reproduces the testing in textile laboratories was elaborated. To test the reliability of this device four sizes, each size available in three lengths, of anti-thromboembolic medical compression stockings were measured at the ankle level using both the Modyn and the reference textile laboratory dynamometer. All the measurements were blindly performed. The measurement procedure followed the G 30 102 B French norm. Results On a total of 72 measurements, the explained variance between both methods was r2= 0.92 and the correlation coefficient r= 0.96. The intra-operator repeatability of the Modyn provided a mean value of 22.12 mmHg, SD 0.74. Conclusion This portable, easy to use, pressure measurement device using the dynamometer principle, is a reliable field tool that should be used in future clinical trials to measure more precisely what the patients treated by compression stockings really receive as therapeutic pressure.