Racial effects on masimo pulse oximetry: impact of low perfusion index.

PURPOSE:  Evaluate the SpO2-SaO2 difference between Black and White volunteer subjects having a low perfusion index (Pi) compared to those having a normal Pi. METHODS:  The Pi data were abstracted from electronic files collected on 7183 paired SpO2-SaO2 samples (3201 Black and 3982 White) from a recently reported desaturation study of 75 subjects (39 Black and 36 White) where SaO2 values were sequentially decreased from 100 to 70%. The Pi values from that dataset were divided into two groups (Pi ≤ 1 or Pi > 1) for analysis. A Pi value ≤ 1 was considered "low perfusion" and a Pi value > 1 was considered "normal perfusion". Statistical calculations included values of bias (mean difference of SpO2-SaO2), precision (standard deviation of the difference), and accuracy (root-mean-square error [ARMS]). During conditions of low perfusion (Pi ≤ 1, range [0.1 to 1]), overall bias and precision were + 0.48% ± 1.59%, while bias and precision were + 0.19 ± 1.53%, and + 0.91 ± 1.57%, for Black and White subjects, respectively. RESULTS:  During normal perfusion (Pi > 1, range [1 to 12]), overall bias and precision were + 0.18% ± 1.34%, while bias and precision were -0.26 ± 1.37%, and - 0.12 ± 1.31%, for Black and White subjects, respectively. ARMS was 1.37% in all subjects with normal perfusion and 1.64% in all subjects with low perfusion. CONCLUSION:  Masimo SET® pulse oximeters with RD SET® sensors are accurate for individuals of both Black and White races when Pi is normal, as well as during conditions when Pi is low. The ARMS for all conditions studied is well within FDA standards. This study was conducted in healthy volunteers during well-controlled laboratory desaturations, and results could vary under certain challenging clinical conditions.

Racial effects on Masimo pulse oximetry: a laboratory study.

Recent publications have suggested that pulse oximeters exhibit reduced accuracy in dark-skinned patients during periods of hypoxemia. Masimo SET® (Signal Extraction Technology®) has been designed, calibrated, and validated using nearly equal numbers of dark and light skinned subjects, with the goal of eliminating differences between pulse oximetry saturation (SpO2) and arterial oxygen saturation (SaO2) values due to skin pigmentation. The accuracy concerns reported in dark-skinned patients led us to perform a retrospective analysis of healthy Black and White volunteers. Seventy-five subjects who self-identified as being racially Black or White underwent a desaturation protocol where SaO2 values were decreased from 100 to 70%, while simultaneous SpO2 values were recorded using Masimo RD SET® sensors. Statistical bias (mean difference) and precision (standard deviation of difference) were - 0.20 ± 1.40% for Black and - 0.05 ± 1.35% for White subjects. Plots of SpO2 versus SaO2 show no significant visible differences between races throughout the saturation range from 70 to 100%. Box plots grouped in 1% saturation bins, from 89-96%, and plotted against concomitant SaO2 values, show that occult hypoxemia (SaO2 < 88% when SpO2 = 92-96%) occurred in only 0.2% of White subject data pairs, but not in any Black subjects. There were no clinically significant differences in bias (mean difference of SpO2-SaO2) found between healthy Black and White subjects. Occult hypoxemia was rare and did not occur in Black subjects. Masimo RD SET® can be used with equal assurance in people with dark or light skin. These laboratory results were obtained in well-controlled experimental conditions in healthy volunteers-not reflecting actual clinical conditions/patients.

Pro-Con Debate: Should Code Sharing Be Mandatory for Publication?

In this Pro-Con commentary article, we discuss whether or not code sharing should be mandatory for scientific publications. Scientific programming is an increasingly prevalent tool in research. However, there are not unified guidelines for code availability requirements. Some journals require code sharing. Others require code descriptions. Yet others have no policies around code sharing. The Pro side presented here argues that code sharing should be mandatory for all scientific publications involving code. This Pro argument comes in 2 parts. First, any defensible reason for not sharing code is an equally valid a reason for the manuscript itself not being published. Second, lack of code sharing requirements creates 2 tiers of science: one where reproducibility is required and one where it is not. Additionally, the Pro authors suggest that a debate over code sharing is itself a decade out-of-date due to the emerging availability of containerization and virtual environment sharing software. The Pro argument concludes with an appeal that authors release code to make their work more understandable by other researchers. The Con side presented here argues that computer source codes of medical technology equipment should not be subject to mandatory public disclosure. The source code is a crucial part of what makes a particular device unique and allows that device to outperform its competition. The Con authors believe that public disclosure of this proprietary information would destroy all incentives for businesses to develop new and improved technologies. Competition in the free marketplace is what drives companies to constantly improve their products, to develop new and better medical devices. The open disclosure of these "trade secret" details would effectively end that competitive drive. Why invest time, money, and energy developing a "better mousetrap" if your competitors can copy it and produce it the next day?

Correspondence to: performance of the new SmartCardia wireless, wearable oximeter: a comparison with arterial SaO2 in healthy volunteers.

In a recent publication in BMC Anesthesiology, Rincon, et al.present accuracy data for three pulse oximeters with sensors located at three different anatomic sites. Their results for the Masimo Radical with fingertip sensor are erroneous, and we present valid data here. Rincon, et al.show a Bias ± Precision of 2.02 ± 4.6, while the correct laboratory values are -0.01 ± 1.16. The most probable reason for these invalid data is that insufficient time was used at each saturation plateau to allow stabilization of SpO2 readings on a fingertip sensor. It has been shown in the literature that fingertip sensors require at least a full minute of stable oxygenation conditions before their readings will be the same as earlobe sensors.

Severe methemoglobinemia detected by pulse oximetry.

An elderly surgical patient acquired a life-threatening methemoglobinemia as a result of topical benzocaine spray to the oropharynx in preparation for awake endotracheal intubation. A new multiwavelength pulse oximeter, the Masimo Rad-57, detected this methemoglobinemia an hour before it was confirmed by laboratory CO-oximetry. The Rad-57 monitored the patient's methemoglobin levels during diagnosis and treatment with methylene blue, and the values it provided (as high as 33%) were very close to those of the laboratory CO-oximeter. The new pulse oximeter gave continuous readings of methemoglobin level at the bedside, whereas the laboratory values were delayed by up to an hour. This case demonstrates the clinical application of a multiwavelength pulse oximeter in the diagnosis and treatment of a life-threatening dyshemoglobinemia.

The measurement of dyshemoglobins and total hemoglobin by pulse oximetry.

PURPOSE OF REVIEW: Recent advances in pulse oximetry have made it possible to noninvasively measure total hemoglobin, as well as the two most common dyshemoglobins. This review will trace the development and clinical application of multiwavelength pulse oximetry. RECENT FINDINGS: Until now, commercially produced pulse oximeters have utilized two wavelengths of light and could measure only the ratio of oxyhemoglobin to total hemoglobin, displayed as SpO2. Pulse oximeters using up to 12 light wavelengths have recently been developed by Masimo Corp. (Irvine, California, USA). These new 'Rainbow Pulse CO-oximeter' instruments can estimate blood levels of carboxyhemoglobin, methemoglobin, and total hemoglobin (SpHb), as well as the conventional SpO2 value. The accuracy of these new measurements has been studied in human volunteers and clinical trials. Some interesting case reports have documented the use of this new technology in diagnosis and treatment. SUMMARY: The development of multiwavelength pulse oximeters, which can measure total hemoglobin as well as dyshemoglobins, should result in improved patient care.

Measurement of carboxyhemoglobin and methemoglobin by pulse oximetry: a human volunteer study.

BACKGROUND: A new eight-wavelength pulse oximeter is designed to measure methemoglobin and carboxyhemoglobin, in addition to the usual measurements of hemoglobin oxygen saturation and pulse rate. This study examines this device's ability to measure dyshemoglobins in human volunteers in whom controlled levels of methemoglobin and carboxyhemoglobin are induced. METHODS: Ten volunteers breathed 500 ppm carbon monoxide until their carboxyhemoglobin levels reached 15%, and 10 different volunteers received intravenous sodium nitrite, 300 mg, to induce methemoglobin. All were instrumented with arterial cannulas and six Masimo Rad-57 (Masimo Inc., Irvine, CA) pulse oximeter sensors. Arterial blood was analyzed by three laboratory CO-oximeters, and the resulting carboxyhemoglobin and methemoglobin measurements were compared with the corresponding pulse oximeter readings. RESULTS: The Rad-57 measured carboxyhemoglobin with an uncertainty of +/-2% within the range of 0-15%, and it measured methemoglobin with an uncertainty of 0.5% within the range of 0-12%. CONCLUSION: The Masimo Rad-57 is the first commercially available pulse oximeter that can measure methemoglobin and carboxyhemoglobin, and it therefore represents an expansion of our oxygenation monitoring capability.

"Motion-resistant" pulse oximetry: a comparison of new and old models.

Several pulse oximeter manufacturers have recently developed instruments that are claimed to be resistant to the effects of patient motion. We performed a laboratory volunteer experiment to compare the performances of several of these instruments, as well as some older models, during combinations of motion and hypoxemia. Twenty oximeters were studied. A motorized table produced different hand motions, and each motion was studied during both room air breathing and hypoxemia. Pulse oximeters on the nonmoving hand were used to provide control measurements for comparison. The Masimo SET((R)) pulse oximeter exhibited the best overall performance, with a performance index (percentage of time in which the SpO(2) reading is within 7% of control value) of 94%. The Agilent Viridia 24C was next, with an 84% index, followed by the Agilent CMS (80%), the Datex-Ohmeda 3740 (80%), and the Nellcor N-395 (69%). For comparison with older oximeter technology, the Criticare 5040 had an index of 28%. Recent technology changes have significantly improved pulse oximeter performance during motion artifact, with the Masimo oximeter leading the way. IMPLICATIONS. New improvements in pulse oximeter technology have resulted in significantly better accuracy and reliability during patient motion. The Masimo pulse oximeter demonstrated the best performance of the 20 instruments tested.