Approaches for calibration and validation of near-infrared optical methods for oxygenation monitoring.

Pulse oximetry for arterial oxygenation monitoring and tissue oximetry for monitoring of cerebral oxygenation or muscle oxygenation are based on quantitative in vivo diffuse optical spectroscopy. However, in both cases the information on absolute or relative concentration of human tissue constituents and especially on hemoglobin oxygenation can often not be retrieved by model-based analysis. An in vivo calibration against an accepted reference measurement can be a practical alternative. Pulse oximeters and most of commercial cerebral tissue oximeters rely on empirical calibration based on invasive controlled human desaturation studies. As invasive in vivo tests on healthy subjects are ethically disputable and should be limited to exceptional cases this calibration practice is unsatisfactory. We present the current status and problems of calibration and validation in pulse oximetry and cerebral tissue oximetry including the pros and cons of in vivo as well as in vitro methods. We emphasize various digital and physical phantom approaches and discuss the prospects of their application and possible further developments.

Design and validation of a pulse oximeter calibrator.

The performance of a new calibrator for pulse oximeters is tested with five pulse oximeters from different manufacturers. The calibrator is based on time resolved transmission spectra of human fingers. Finger spectra with different arterial oxygen saturation can be selected to simulate real patients. The results obtained with this calibration device are compared with the results of conventional calibration procedures with volunteers. Beside accuracy tests the suitability for artifact simulation with the new device is discussed. The response of the five tested pulse oximeters is in good agreement with the response of the pulse oximeters connected to real patients. A test procedure for pulse oximeters similar to the conventional desaturation practice is possible; some of the typical artifacts pulse oximetry has to cope with can be simulated easily.

The effects of motion artifact and low perfusion on the performance of a new generation of pulse oximeters in volunteers undergoing hypoxemia.

INTRODUCTION: Motion artifact and low perfusion often lead to faulty or absent pulse oximetry readings in clinical practice. OBJECTIVE: Determine the impact of motion artifact and low perfusion on newly introduced pulse oximetry technologies during hypoxemic episodes in healthy volunteers. METHODS: Five different pulse oximeters from 4 manufacturers (the Datex Ohmeda 3900P; the Agilent; the Nellcor N-3000; the Nellcor N-395; and the Schiller OX-1, which is the European version of the Ivy SatGuard 2000 with Masimo SET) were compared with respect to their ability (separated or in combination) to provide accurate readings in the presence of motion artifact and low perfusion. Four of these oximeters represent the latest available oximetry technology, and one (the N-3000) represents a previous generation of oximeters. Oxygen saturation values (S(pO(2))) and pulse rate from the oximeters were recorded during episodes of induced hypoxemia in 10 healthy volunteers. Standardized and repeatable motion artifacts were generated by a motion machine and by having the test subject perform tapping and scratching motions. Perfusion to the finger was reduced by an inflatable balloon impinging on the brachial artery. The pulse oximetry readings from the test oximeters were compared to readings from control pulse oximeters on the unperturbed reference hand. The pulse rates from the test oximeters were compared to the electrocardiographically-measured heart rate. RESULTS: The frequency of faulty readings was increased by increasing motion interference and decreasing perfusion. The S(pO(2)) deviation was within +/- 3% of the reference reading > 95% of the time for all instruments during the control desaturation period in the absence of motion and with normal perfusion. With the combination of motion and low perfusion, the S(pO(2)) error was within +/- 3% less than 62% of the time for all oximeters tested. A significant difference in the frequency of large S(pO(2)) errors was observed only in the direct comparison of the N-395 and N-3000. The N-395 exhibited less frequent S(pO(2)) error exceeding 6% of S(pO(2)) in the combination of the most challenging situations (motion and motion with reduced perfusion). In the same situation the Datex-Ohmeda 3900P and Nellcor N-3000 showed significantly higher pulse rate errors than the other devices (Datex-Ohmeda 3900P 53% of the time and N-3000 37% of the time). CONCLUSIONS: The established model of creating motion artifact and low perfusion is capable of simulating a hierarchy of severe clinical situations. With solely motion or solely reduced perfusion the percentage of errors exceeding +/- 3% of S(pO(2)) increased by 20% and 10%, respectively, compared to the control period. Simultaneous presence of motion and reduced perfusion leads to a relative incidence of > 35% of errors > 3% of S(pO(2)) for the various oximeters. In this situation the N-3000 and the Datex-Ohmeda 3900P exhibited differences between estimated pulse rate and electrocardiographically-measured heart rate > 25 beats/min > 37% of the time.