Current Status of Measurement Accuracy for Total Hemoglobin Concentration in the Clinical Context.

OBJECTIVE: The main objective of this investigation is to provide data about the accuracy of total hemoglobin concentration measurements with respect to clinical settings, and to devices within the categories of point-of-care and reference systems. In particular, tolerance of hemoglobin concentrations below 9 g/dL that have become common in clinical practice today determines the need to demonstrate the limits of measurement accuracy in patient care. METHODS: Samples extracted from six units of heparinized human blood with total hemoglobin concentrations ranging from 3 to 18 g/dL were assigned to the test devices in a random order. The pool of test devices comprised blood gas analyzers, an automatic hematology analyzer, a laboratory reference method, and the point-of-care system HemoCue. To reduce the pre-analytic error, each sample was measured three times. Due to the characteristics of the tested devices and methods, we selected the mean values of the data from all these devices, measured at the corresponding total hemoglobin concentrations, as the reference. MAIN RESULTS: The measurement results of the test devices overlap within strict limits (R2 = 0.999). Only the detailed analysis provides information about minor but systematic deviations. In the group of clinically relevant devices, which are involved in patient blood management decisions, the relative differences were within the limit of +/- 5 % for values down to 3 g/dL. CONCLUSIONS: A clinically relevant change of +/- 0.5 g/dL of total hemoglobin concentration can be detected with all selected devices and methods. Compliance with more stringent definitions-these are the relative differences of 5 % in relation to the corresponding reference values and the clinically adapted thresholds in the format of a tolerance level analysis-was achieved by the clinical devices assessed here.

Measurement of Blood Pressure by Ultrasound-The Applicability of Devices, Algorithms and a View in Local Hemodynamics.

OBJECTIVE: Due to ongoing technical progress, the ultrasonic measurement of blood pressure (BP) as an alternative to oscillometric measurement (NIBP) or the continuous non-invasive arterial pressure method (CNAP) moves further into focus. The US method offers several advantages over NIBP and CNAP, such as deep tissue penetration and the utilization of different arterial locations. APPROACH: Ten healthy subjects (six female, aged 30.9 ± 4.6 years) volunteered in our investigation. In the ultrasonic BP measurement, we differentiated between the directly measured (pulsatile diastolic and systolic vessel diameter) and indirectly calculated variables at three different artery locations on both arms, with two different ultrasound devices in the transversal and longitudinal directions of the transducer. Simultaneously, NIBP monitoring served as reference BP, while CNAP monitored the steady state condition of the arm under investigation. The Moens-Korteweg algorithm (MKE) and the algorithm of the working group of San Diego (SanD) were selected for the indirectly calculated ultrasonic BP data. MAIN RESULTS: With US, we were able to measure the BP at each selected arterial position. Due to the investigation setup, we found small but significant interactions of the main effects. Bland and Altman analysis revealed that US-BP measurement was similar to NIBP, with superior accuracy when compared to the established CNAP method. In addition, US-BP measurement showed that the measurement accuracy of both arms can be regarded as identical. In a detailed comparison of the selected arterial vascular sections, systematic discrepancies between the right and left arm could be observed. CONCLUSION: In our pilot study, we measured BP effectively and accurately by US using two different devices. Our findings suggest that ultrasonic BP measurement is an adequate alternative for live and continuous hemodynamic monitoring.

Brachialis Pulse Wave Measurements with Ultra-Wide Band and Continuous Wave Radar, Photoplethysmography and Ultrasonic Doppler Sensors.

The measurement and analysis of the arterial pulse wave provides information about the state of vascular health. When measuring blood pressure according to Riva-Rocci, the systolic and diastolic blood pressure is measured non-invasively with an inflatable pressure cuff on the upper arm. Today's blood pressure monitors analyze the pulse wave in reference to the rising or falling cuff pressure. With the help of additional pulse wave analysis, one can determine the pulse rate and the heart rate variability. In this paper, we investigated the concept, the construction, and the limitations of ultrawideband (UWB) radar and continuous wave (CW) radar, which provide continuous and non-invasive pulse wave measurements. We integrated the sensors into a complete measurement system. We measured the pulse wave of the cuff pressure, the radar sensor (both UWB and CW), the optical sensor, and ultrasonic Doppler as a reference. We discussed the results and the sensor characteristics. The main conclusion was that the resolution of the pulse radar was too low, even with a maximum bandwidth of 10 GHz, to measure pulse waves reliably. The continuous wave radar provides promising results for a phantom if adjusted properly with phase shifts and frequency. In the future, we intend to develop a CW radar solution with frequency adaption.

Invasive and non-invasive point-of-care testing and point-of-care monitoring of the hemoglobin concentration in human blood - how accurate are the data?

In this review, scientific investigations of point-of-care testing (POCT) and point-of-care monitoring (POCM) devices are summarized with regard to the measurement accuracy of the hemoglobin concentration. As a common basis, information according to the Bland and Altman principle [bias, limits of agreement (LOA)] as well as the measurement accuracy and precision are considered, so that the comparability can be mapped. These collected data are subdivided according to the manufacturers, devices and procedures (invasive and non-invasive). A total of 31 devices were identified. A comparability of the scientific investigations in particular was given for 23 devices (18 invasive and five non-invasive measuring devices). In terms of measurement accuracy, there is a clear leap between invasive and non-invasive procedures, while no discernible improvement can be derived in the considered time frame from 2010 to 2018. According to the intended use, strict specifications result from the clinical standards, which are insufficiently met by the systems. More stringent requirements can be derived both in the area of blood donation and in the treatment of patients.