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.
The TensorTip MTX device demonstrated unreliable blood pressure measurements compared to invasive methods, showing significant errors and a high malfunction rate, deeming it clinically unacceptable for perioperative use.
Area of Science:
- Medical Devices
- Cardiovascular Monitoring
- Anesthesiology
Background:
- The TensorTip MTX is a noninvasive device designed to measure blood pressure by analyzing finger skin blood diffusion.
- It also measures other vital signs like heart rate, oxygen saturation, stroke volume, and cardiac output.
- Previous accuracy and precision studies were manufacturer-conducted.
Purpose of the Study:
- To evaluate the accuracy and precision of the TensorTip MTX.
- To compare TensorTip MTX measurements against invasive radial artery blood pressure values.
Main Methods:
- Forty-one surgical patients were enrolled.
- Blood pressure was measured invasively via radial artery catheter and noninvasively with the TensorTip MTX.
- Bland-Altman plots and error grid analysis were used for comparison.
Main Results:
- Systolic, diastolic, and mean blood pressure showed biases of 6.2, -6.9, and 4.4 mm Hg, respectively.
- Percentage errors were high: 47.6% (systolic), 52.9% (diastolic), and 52.3% (mean).
- Only 61.0% of systolic and 46.3% of mean blood pressure readings fell within the clinically acceptable zone.
Conclusions:
- The TensorTip MTX exhibits unacceptable measurement performance for blood pressure compared to invasive monitoring.
- A high device malfunction rate further limits its suitability for perioperative settings.
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