UNASSIGNED: This year, 2024, marks the 50th anniversary of the invention of pulse oximetry (PO), which was first presented by Takuo Aoyagi, an engineer from the Nihon Kohden Company, at the 13th Conference of the Japanese Society of Medical Electronics and Biological Engineering in Osaka in 1974. His discovery and the development of PO for the non-invasive measurement of peripheral arterial oxygenation represents one of the most significant chapters in the history of medical technology. It resulted from research and development efforts conducted by biochemists, engineers, physicists, physiologists, and physicians since the 1930s.
UNASSIGNED: The objective of this work was to provide a narrative review of the history, current status, and future prospects of PO.
UNASSIGNED: A comprehensive review of the literature on oximetry and PO was conducted.
UNASSIGNED: Our historical review examines the development of oximetry in general and PO in particular, tracing the key stages of a long and fascinating story that has unfolded from the first half of the twentieth century to the present day-an exciting journey in which serendipity has intersected with the hard work of key pioneers. This work has been made possible by the contributions of numerous key pioneers, including Kurt Kramer, Karl Matthes, Glenn Millikan, Evgenii M. Kreps, Earl H. Wood, Robert F. Show, Scott A. Wilber, William New, and, above all, Takuo Aoyagi. PO has become an integral part of modern medical care and has proven to be an important tool for physiological monitoring. The COVID-19 pandemic not only highlighted the clinical utility of PO but also revealed some of the problems with the technology. Current research in biomedical optics should address these issues to make the technology even more reliable and accurate. We discuss the necessary innovations in PO and present our thoughts on what the next generation of PO might look like.

This publication presents the effect of hypochlorous acid dry mist as a disinfectant on selected bacteria, viruses, spores, and fungi as well as on portable Microlife OXY 300 finger pulse oximeters and electronic systems of Raspberry Pi Zero microcomputers. The impact of hypochlorous acid on microbiological agents was assessed at concentrations of 300, 500, and 2000 ppm of HClO according to PN-EN 17272 (Variant I). Studies of the impact of hypochlorous acid fog on electronic components were carried out in an aerosol chamber at concentrations of 500 ppm and 2000 ppm according to two models consisting of 30 (Variant II) and 90 fogging cycles (Variant III). Each cycle included the process of generating a dry mist of hypochlorous acid (25 mL/m3), decontamination of the test elements, as well as cleaning the chamber of the disinfectant agent. The exposure of the materials examined on hypochlorous acid dry mist in all variants resulted in a decrease in the number of viruses, bacteria, spores, and fungi tested. In addition, the research showed that in the variants of hypochlorous acid fogging cycles analyzed, no changes in performance parameters and no penetration of dry fog of hypochlorous acid into the interior of the tested medical devices and electronic systems were observed.

UNASSIGNED: Compare heart rate assessment methods in the delivery room on newborn clinical outcomes.
UNASSIGNED: A search of Medline, SCOPUS, CINAHL and Cochrane was conducted between January 1, 1946, to until August 16, 2023. (CRD 42021283438) Study Selection was based on predetermined criteria. Reviewers independently extracted data, appraised risk of bias and assessed certainty of evidence.
UNASSIGNED: Two randomized controlled trials involving 91 newborns and 1 nonrandomized study involving 632 newborns comparing electrocardiogram (ECG) to auscultation plus pulse oximetry were included. No studies were found that compared any other heart rate measurement methods and reported clinical outcomes. There was no difference between the ECG and control group for duration of positive pressure ventilation, time to heart rate ≥ 100 beats per minute, epinephrine use or death before discharge. In the randomized studies, there was no difference in rate of tracheal intubation [RR 1.34, 95% CI (0.69-2.59)]. No participants received chest compressions. In the nonrandomized study, fewer infants were intubated in the ECG group [RR 0.75, 95% CI (0.62-0.90)]; however, for chest compressions, benefit or harm could not be excluded. [RR 2.14, 95% (CI 0.98-4.70)].
UNASSIGNED: There is insufficient evidence to ascertain clinical benefits or harms associated with the use of ECG versus pulse oximetry plus auscultation for heart rate assessment in newborns in the delivery room.

UNASSIGNED: To examine speed and accuracy of newborn heart rate measurement by various assessment methods employed at birth.
UNASSIGNED: A search of Medline, SCOPUS, CINAHL and Cochrane was conducted between January 1, 1946, to until August 16, 2023. (CRD 42021283364) Study selection was based on predetermined criteria. Reviewers independently extracted data, appraised risk of bias and assessed certainty of evidence.
UNASSIGNED: Pulse oximetry is slower and less precise than ECG for heart rate assessment. Both auscultation and palpation are imprecise for heart rate assessment. Other devices such as digital stethoscope, Doppler ultrasound, an ECG device using dry electrodes incorporated in a belt, photoplethysmography and electromyography are studied in small numbers of newborns and data are not available for extremely preterm or bradycardic newborns receiving resuscitation. Digital stethoscope is fast and accurate. Doppler ultrasound and dry electrode ECG in a belt are fast, accurate and precise when compared to conventional ECG with gel adhesive electrodes.
UNASSIGNED: Certainty of evidence was low or very low for most comparisons.
UNASSIGNED: If resources permit, ECG should be used for fast and accurate heart rate assessment at birth. Pulse oximetry and auscultation may be reasonable alternatives but have limitations. Digital stethoscope, doppler ultrasound and dry electrode ECG show promise but need further study.

BACKGROUND: Pulse oximeters work within the red-infrared wavelengths. Therefore, these oximeters produce erratic results in dark-skinned subjects and in subjects with cold extremities. Pulse oximetry is routinely performed in patients with fever; however, an elevation in body temperature decreases the affinity of hemoglobin for oxygen, causing a drop in oxygen saturation or oxyhemoglobin concentrations.
OBJECTIVE: We aimed to determine whether our new investigational device, the Shani device or SH1 (US Patent 11191460), detects a drop in oxygen saturation or a decrease in oxyhemoglobin concentrations.
METHODS: An observational study (phase 1) was performed in two separate groups to validate measurements of hemoglobin and oxygen concentrations, including 39 participants recruited among current university students and staff aged 20-40 years. All volunteers completed baseline readings using the SH1 device and the commercially available Food and Drug Administration-approved pulse oximeter Masimo. SH1 uses two light-emitting diodes in which the emitted wavelengths match with absorption peaks of oxyhemoglobin (hemoglobin combined with oxygen) and deoxyhemoglobin (hemoglobin without oxygen or reduced hemoglobin). Total hemoglobin was calculated as the sum of oxyhemoglobin and deoxyhemoglobin. Subsequently, 16 subjects completed the \"heat jacket study\" and the others completed the \"blood donation study.\" Masimo was consistently used on the finger for comparison. The melanin level was accounted for using the von Luschan skin color scale (VLS) and a specifically designed algorithm. We here focus on the results of the heat jacket study, in which the subject wore a double-layered heated jacket and pair of trousers including a network of polythene tubules along with an inlet and outlet. Warm water was circulated to increase the body temperature by 0.5-0.8 °C above the baseline body temperature. We expected a slight drop in oxyhemoglobin concentrations in the heating phase at the tissue level.
RESULTS: The mean age of the participants was 24.1 (SD 0.8) years. The skin tone varied from 12 to 36 on the VLS, representing a uniform distribution with one-third of the participants having fair skin, brown skin, and dark skin, respectively. Using a specific algorithm and software, the reflection ratio for oxyhemoglobin was displayed on the screen of the device along with direct hemoglobin values. The SH1 device picked up more minor changes in oxyhemoglobin levels after a change in body temperature compared to the pulse oximeter, with a maximum drop in oxyhemoglobin concentration detected of 6.5% and 2.54%, respectively.
CONCLUSIONS: Our new investigational device SH1 measures oxygen saturation at the tissue level by reflectance spectroscopy using green wavelengths. This device fared well regardless of skin color. This device can thus eliminate racial disparity in these key biomarker assessments. Moreover, since the light is shone on the wrist, SH1 can be readily miniaturized into a wearable device.

BACKGROUND: Over recent years, technological advances in wearables have allowed for continuous home monitoring of heart rate and oxygen saturation. These devices have primarily been used for sports and general wellness and may not be suitable for medical decision-making, especially in saturations below 90% and in patients with dark skin color. Wearable clinical-grade saturation of peripheral oxygen (SpO2) monitoring can be of great value to patients with chronic diseases, enabling them and their clinicians to better manage their condition with reliable real-time and trend data.
OBJECTIVE: This study aimed to determine the SpO2 accuracy of a wearable ring pulse oximeter compared with arterial oxygen saturation (SaO2) in a controlled hypoxia study based on the International Organization for Standardization (ISO) 80601-2-61:2019 standard over the range of 70%-100% SaO2 in volunteers with a broad range of skin color (Fitzpatrick I to VI) during nonmotion conditions. In parallel, accuracy was compared with a calibrated clinical-grade reference pulse oximeter (Masimo Radical-7). Acceptable medical device accuracy was defined as a maximum of 4% root mean square error (RMSE) per the ISO 80601-2-61 standard and a maximum of 3.5% RMSE per the US Food and Drug Administration guidance.
METHODS: We performed a single-center, blinded hypoxia study of the test device in 11 healthy volunteers at the Hypoxia Research Laboratory, University of California at San Francisco, under the direction of Philip Bickler, MD, PhD, and John Feiner, MD. Each volunteer was connected to a breathing apparatus for the administration of a hypoxic gas mixture. To facilitate frequent blood gas sampling, a radial arterial cannula was placed on either wrist of each participant. One test device was placed on the index finger and another test device was placed on the fingertip. SaO2 analysis was performed using an ABL-90 multi-wavelength oximeter.
RESULTS: For the 11 participants included in the analysis, there were 236, 258, and 313 SaO2-SpO2 data pairs for the test device placed on the finger, the test device placed on the fingertip, and the reference device, respectively. The RMSE of the test device for all participants was 2.1% for either finger or fingertip placement, while the Masimo Radical-7 reference pulse oximeter RMSE was 2.8%, exceeding the standard (4% or less) and the Food and Drug Administration guidance (3.5% or less). Accuracy of SaO2-SpO2 paired data from the 4 participants with dark skin in the study was separately analyzed for both test device placements and the reference device. The test and reference devices exceeded the minimum accuracy requirements for a medical device with RMSE at 1.8% (finger) and 1.6% (fingertip) and for the reference device at 2.9%.
CONCLUSIONS: The wearable ring meets an acceptable standard of accuracy for clinical-grade SpO2 under nonmotion conditions without regard to skin color.
BACKGROUND: ClinicalTrials.gov NCT05920278; https://clinicaltrials.gov/study/NCT05920278.

UNASSIGNED: Pulse oximeters noninvasively measure blood oxygen levels, but these devices have rarely been designed for low-resource settings and are inconsistently available at outpatient clinics.
UNASSIGNED: The Phefumla project aims to develop and validate a pediatric smartphone-based pulse oximeter designed specifically for this context. We present the process of human-centered oximeter design with health care workers in South Africa.
UNASSIGNED: We purposively sampled 19 health care workers from 5 clinics in Khayelitsha, Cape Town. Using a human-centered design approach, we conducted participatory workshops with four activities with health care workers: (1) they received 3D-printed prototypes of potential oximeter designs to provide feedback; (2) we demonstrated on dolls how they would use the novel oximeter; (3) they used pile sorting to rank design features and suggest additional features they desired; and (4) they designed their preferred user interface using a whiteboard, marker, and magnetized features that could be repositioned. We audio recorded the workshops, photographed outputs, and took detailed field notes. Analysis involved iterative review of these data to describe preferences, identify key design updates, and provide modifications.
UNASSIGNED: Participants expressed a positive sentiment toward the idea of a smartphone pulse oximeter and suggested that a pediatric device would address an important gap in outpatient care. Specifically, participants expressed a preference for the prototype that they felt enabled more diversity in the way it could be used. There was a strong tendency to prioritize pragmatic design features, such as robustness, which was largely dictated by health care worker context. They also added features that would allow the oximeter device to serve other clinical functions in addition to oxygen saturation measurement, such as temperature and respiratory rate measurements.
UNASSIGNED: Our end user-centered rapid participatory approach led to tangible design changes and prompted design discussions that the team had not previously considered. Overall, health care workers prioritized pragmatism for pediatric pulse oximeter device design.

Pulse oximetry is arguably the most impactful monitor ever introduced into respiratory care practice. Recently there has been increased attention to the problem of occult hypoxemia in which patients are hypoxemic despite an acceptable SpO2 Although occult hypoxemia might be greater in Black patients than white patients, it is not insignificant in whites. In a given population of patients, the bias between SpO2 and arterial oxygen saturation (SaO2 ) might be close to zero. However, the limits of agreement can be wide, meaning that SpO2 might overestimate SaO2 in many individual patients, which can result in occult hypoxemia in some. Manufactures report accuracy of SpO2 derived from normal individuals, which might differ from that in the clinical setting. That SpO2 overestimates SaO2 in an important number of individuals has caused some to recommend higher SpO2 targets to avoid occult hypoxemia. There is also evidence that suggests that SpO2 might not accurately trend SaO2 Additional research is needed to investigate strategies to mitigate the bias between SpO2 and SaO2 Clinicians must be cognizant of the limitations of pulse oximetry when clinically using SpO2 The aim of this paper is to provide an update on pulse oximetry.

UNASSIGNED: Patients are hospitalized for extended periods, particularly in intensive care units (ICUs). As a result, the saturation probe (pulse oximeter) remains attached for an extended period and microorganisms can grow in the wet environment. If the pulse oximeters are not reprocessed, cross-infection may occur. The literature contains several studies in which gloves were used for the measurement while various SpO2 (peripheral arterial oxygen saturation) measurements were compared with each other. However, such comparisons have yet to be made with the results of arterial blood gas SpO2 measurements by pulse oximeter, considered as the gold standard. The present study aimed to compare arterial blood gas values with the fingertip saturation measurement performed by having adult patients wear gloves of different colors, one after the other, on their fingers and determining the effect of the differently colored gloves (transparent, white, black, light blue) on saturation values.
UNASSIGNED: The study was conducted on 54 patients in an ICU. Intra-arterial blood gas SpO2 results were measured. Oxygen saturation was measured while the patient 1. did not wear gloves and 2. sequentially wore a series of gloves of different colors. Paired t-test, correlation analysis, and Bland Altman charts were used to evaluate the results.
UNASSIGNED: The mean SpO2% value of the participants\' intra-arterial blood gas measurements was 97.76±2.04. The mean SpO2% value obtained from the measurements of the fingers with a transparent glove was 0.43 points lower than the mean SpO2% value of the intra-arterial blood gas measurements (t=0.986, p=0.61). The mean SpO2% value obtained from the measurements of the fingers with a white glove was 0.93 points lower than the mean SpO2% value of the intra-arterial blood gas measurements (t=1.157, p=0.093).
UNASSIGNED: Of the measurements performed with a glove, the mean SpO2% value obtained from the measurements of the fingers with a transparent glove was more consistent with the mean SpO2% value of the intra-arterial blood gas measurements than measurement of the fingers without a glove.
UNASSIGNED: Patienten werden über längere Zeiträume stationär behandelt, insbesondere auf Intensivstation und Mikroorganismen können sich in der feuchten Kammer vermehren. Werden die Sättigungssonden nicht aufbereitet, kann es zu Kreuzinfektionen kommen. In der Literatur wurden mehrere Studien durchgeführt, in denen Handschuhe zur Messung verwendet wurden, wobei verschiedene SpO2-Messungen miteinander verglichen wurden. Solche Vergleiche mit den Ergebnissen arterieller Blutgas-SpO2-Messungen, die als Goldstandard gelten, stehen jedoch aus. Ziel der vorliegenden Studie war es, arterielle Blutgaswerte mit der Sättigungsmessung an den Fingerspitzen bei der erwachsene Patienten zu vergleichen, die transparente Handschuhe unterschiedlicher Farbe an den Fingern trugen, um die Auswirkung von Handschuhen auf die Sättigungswerte zu bestimmen.
UNASSIGNED: Die Studie wurde an 54 Patienten auf einer Intensivstation durchgeführt. Die intraarteriellen Blutgas-SpO2-Ergebnisse der Patienten wurden gemessen. Die Sauerstoffsättigung wurde gemessen, wenn der Patient keine Handschuhe bzw. einen andersfarbigen Handschuh trug. Bei der Analyse der Studie wurden der gepaarte T-Test, die Korrelationsanalyse und Bland-Altman-Diagramme verwendet.
UNASSIGNED: Der mittlere SpO2%-Wert der intraarteriellen Blutgasmessungen betrug 97,76±2,04. Der mittlere SpO2%-Wert aus den Messungen der Finger mit einem transparenten Handschuh war 0,43 Punkte niedriger als der mittlere SpO2%-Wert der intraarteriellen Blutgasmessungen (t=0,986, p=0,61). Der mittlere SpO2%-Wert aus den Messungen der Finger mit einem weißen Handschuh war 0,93 Punkte niedriger als der mittlere SpO2%-Wert der intraarteriellen Blutgasmessungen (t=1,157, p=0,093).
UNASSIGNED: Bei den mit Handschuhen durchgeführten Messungen stimmte der mittlere SpO2%-Wert, der aus den Messungen an den Fingern mit einem transparenten Handschuh erhalten wurde, besser mit dem mittleren SpO2%-Wert der intraarteriellen Blutgasmessungen überein als bei Messung am Finger ohne Handschuh.

Pulse oximeters\' (POs) varying performance based on skin tones has been highly publicised. Compared to arterial blood gas analysis, POs tend to overestimate oxygen saturation (SpO2) values for people with darker skin (occult hypoxemia). The objective is to develop a test bench for assessing commercial home and hospital-based POs in controlled laboratory conditions. A laboratory simulator was used to mimic different SpO2 values (~ 70 to 100%). Different neutral density and synthetic melanin filters were used to reproduce low signal and varying melanin attenuation levels. Six devices consisting of commercial home (Biolight, N = 13; ChoiceMMed, N = 18; MedLinket, N = 9) and hospital-based (Masimo Radical 7 with Neo L, N = 1; GE B450 Masimo SET with LNCS Neo L, N = 1; Nonin 9550 Onyx II™, N = 1) POs were reviewed and their response documented. Significant variations were observed in the recorded SpO2 values among different POs when exposed to identical simulated signals. Differences were greatest for lower SpO2 (< 80%) where empirical data is limited. All PO responses under low signal and melanin attenuation did not change across various simulated SpO2 values. The bench tests do not provide conclusive evidence that melanin does not affect in vivo SpO2 measurements. Research in the areas of instrument calibration, theory and design needs to be further developed.