Perioperative Validation of the TensorTip™ MTX Device for Noninvasive Arterial Pressure Measurement: A Method
Sjoerd Servaas1, Lucas T van Eijk1, Silke de Vreede1
1Department of Anaesthesiology, Pain and Palliative Medicine, Radboud University Medical Centre, 6500 HB Nijmegen, The Netherlands.
Background:
The noninvasive TensorTip™ MTX measures blood pressure by interpreting blood diffusion color of the finger skin. In addition to blood pressure, the device is able to measure various vital signs: heart rate, oxygen saturation, stroke volume, and cardiac output. Studies about accuracy and precision thus far available have only been conducted by the manufacturer. The aim of our study was to investigate the accuracy and precision of the TensorTip MTX in comparison to invasive radial artery blood pressure values.
Methods:
Forty-one patients scheduled for elective surgery were enrolled in this study. Placement of the arterial catheter had to be part of the standard of care. Once hemodynamic stable conditions were achieved, blood pressure was measured. Three measurements with the TensorTip MTX were averaged and compared with one invasive blood pressure measurement using Bland-Altman plot and error grid analysis.
Results:
Systolic, diastolic, and mean blood pressure had a bias of respectively 6.2, -6.9 and 4.4 mm Hg. Corresponding standard deviation were respectively 30.1, 17.0 and 22.2. Calculated percentage errors were 47.6%, 52.9% and 52.3%. Proportional bias was present in all Bland-Altman analyses. Error grid analysis showed 61.0% of systolic blood pressure measurements, and 46.3% of mean blood pressure measurements were in the clinical acceptable zone.
Conclusions:
The TensorTip MTX was not able to reliably measure blood pressure compared to blood pressure obtained with an arterial catheter and therefore, the measurement performance is not clinically acceptable. Moreover, a high malfunction rate makes the device unsuitable for use in perioperative period.
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