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Objective: This study aims to develop a measurement model for health technology acceptability using a theoretical framework and a range of validated instruments to measure user experience, acceptance, usability, health and digital health literacy. Methods: A cross-sectional evaluation study using a mixed-methods approach was conducted. An online survey was administered to patients who used a pulse oximeter in a virtual hospital setting during COVID-19. The model development was conducted in three steps: (1) exploratory factor analysis for conceptual model development, (2) measurement model confirmation through confirmatory factor analysis followed by structural equation modelling and (3) test of model external validity on four outcome measures. Finally, the different constructs of the developed model were used to compare two types of pulse oximeters by measuring the standardised scores. Results: Two hundred and two participants were included in the analysis, 37.6% were female and the average age was 53 years (SD:15.38). A four-construct model comprising Task Load, Affective Attitude, Self-Efficacy and Value of Use (0.636-0.857 factor loadings) with 12 items resulted from the exploratory factor analysis and yielded a good fit (RMSEA = .026). Health and digital health literacy did not affect the overall reliability of the model. Frustration, performance, trust and satisfaction were identified as outcomes of the model. No significant differences were observed in the acceptability constructs when comparing the two pulse oximeter devices. Conclusions: This article proposes a model for the measurement of the acceptability of health technologies used by patients in a remote care setting based on the use of a pulse oximeter in COVID-19 remote monitoring.

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Significance: 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. Aim: The objective of this work was to provide a narrative review of the history, current status, and future prospects of PO. Approach: A comprehensive review of the literature on oximetry and PO was conducted. Results and Conclusions: 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.

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Background: A major drawback of traditional pulp testing procedures is that they depend on neural responses rather than vascular circulation. Hence, this study aimed to develop a custom-modified dental sensor using a finger pulse oximeter (PO) that is applicable to any type of tooth so as to test its ability and accuracy in evaluating the oxygen saturation (SaO2) values of teeth at different developmental stages as a measure of pulp vitality. Materials and methods: A customized finger PO was employed to determine the systemic and pulp SaO2 levels in 300 children. A total of 600 teeth (primary and permanent) were divided into group I (100 primary molars), group II (200 permanent molars), group III (200 permanent incisors), and 100 endodontically treated (primary and permanent) teeth were included in group IV. The mean SaO2 values thus obtained in various groups were compared. Results: Intragroup comparison of mean SaO2% of the patient's finger (systemic), test teeth, and control teeth showed significant differences (p ≤ 0.001). Intergroup comparisons also revealed significant differences in most of the groups. Conclusions: The modified PO probe can be applied to any type of tooth. It was found to be accurate and sensitive enough to detect changes in SaO2 levels in various clinical situations irrespective of developmental stage. It proved to be a direct method of evaluation of pulp vitality by objective means. How to cite this article: Patil A, Garg N, Pathivada L, et al. Evaluation of Oxygen Saturation Levels Using a Custom-modified Finger Pulse Oximeter for Assessment of Pulp Vitality in Various Clinical Situations in Pediatric Dental Practice: An In Vivo Study. Int J Clin Pediatr Dent 2024;17(S-1):S30-S36.

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Significance: Our goal is to understand the root cause of reported oxygen saturation ( SpO 2 ) overestimation in heavily pigmented skin types to devise solutions toward enabling equity in pulse oximeter designs. Aim: We aim to gain theoretical insights into the effect of skin tone on SpO 2 - R curves using a three-dimensional, four-layer tissue model representing a finger. Approach: A finger tissue model, comprising the epidermis, dermis, two arteries, and a bone, was developed using a Monte Carlo-based approach in the MCmatlab software. Two skin tones-light and dark-were simulated by adjusting the absorption and scattering properties within the epidermal layer. Following this, SpO 2 - R curves were generated in various tissue configurations, including transmission and reflection modes using red and infrared wavelengths. In addition, the influence of source-detector (SD) separation distances on both light and dark skin tissue models was studied. Results: In transmission mode, SpO 2 - R curves did not deviate with changes in skin tones because both pulsatile and non-pulsatile terms experienced equal attenuation at red and infrared wavelengths. However, in reflection mode, measurable variations in SpO 2 - R curves were evident. This was due to differential attenuation of the red components, which resulted in a lower perfusion index at the red wavelength in darker skin. As the SD separation increased, the effect of skin tone on SpO 2 - R curves in reflection mode became less pronounced, with the largest SD separation exhibiting effects similar to those observed in transmission mode. Conclusions: Monte Carlo simulations have demonstrated that different light pathlengths within the tissue contribute to the overestimation of SpO 2 in people with darker skin in reflection mode pulse oximetry. Increasing the SD separation may mitigate the effect of skin tone on SpO 2 readings. These trends were not observed in transmission mode; however, further planned research using more complex models of the tissue is essential.

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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.

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Aim: Compare heart rate assessment methods in the delivery room on newborn clinical outcomes. Methods: 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. Results: 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)]. Conclusion: 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.

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Background: 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. Objective: 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. Methods: 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. Results: 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. Conclusions: 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.

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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. TRIAL REGISTRATION: ClinicalTrials.gov NCT05920278; https://clinicaltrials.gov/study/NCT05920278.

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Aim: To examine speed and accuracy of newborn heart rate measurement by various assessment methods employed at birth. Methods: 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. Results: 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. Limitations: Certainty of evidence was low or very low for most comparisons. Conclusion: 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.

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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.

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Intrapartum care uses electronic fetal heart rate monitoring (EFHRM) for over 50 years to indirectly assess fetal oxygenation. However, this approach has been associated with an increase in cesarean delivery rates and limited improvements in neonatal hypoxic outcome. To address these shortcomings, a novel transabdominal fetal pulse oximeter (TFO) is being developed to provide an objective measurement of fetal oxygenation. Previous studies have evaluated the performance of TFO on pregnant ewe. Building on the animal model, this study aims to determine whether TFO can successfully capture human fetal heart rate (FHR) signals during non-stress testing (NST) as a proof-of-concept. Eight ongoing pregnancies meeting specific inclusion criteria (18-40 years old, singleton, and at least 36 weeks' gestation) were enrolled with consent. Each study session was 15 to 20 min long. Reference maternal heart rate (MHR) and FHR were obtained using finger pulse oximetry and cardiotocography for subsequent comparison. The overall root-mean-square error was 9.7BPM for FHR and 4.4 for MHR, while the overall mean-absolute error was 7.6BPM for FHR and 1.8 for MHR. Bland-Altman analysis displayed a mean bias ± standard deviation between TFO and reference of -3.9 ± 8.9BPM, with limits of agreement ranging from -21.4 to 13.6 BPM. Both maternal and fetal heart rate measurements obtained from TFO exhibited a p-value < 0.001, showing significant correlation with the reference. This proof-of-concept study successfully demonstrates that TFO can accurately differentiate maternal and fetal heart signals in human subjects. This achievement marks the initial step towards enabling fetal oxygen saturation measurement in humans using TFO.

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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.

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Background: 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. Methods: 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. Results: 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). Conclusion: 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.

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Data from the Neonatal Oxygenation Prospective Meta-analysis (NeOProM) indicate that targeting a higher (91-95%) versus lower (85-89%) pulse oximeter saturation (SpO2) range may reduce mortality and necrotizing enterocolitis (NEC) and increase retinopathy of prematurity (ROP). Aiming to re-evaluate the strength of this evidence, we conducted a Bayesian reanalysis of the NeOProM data. We used Bayes factors (BFs) to evaluate the likelihood of the data under the combination of models assuming the presence vs. absence of effect, heterogeneity, and moderation by sex. The Bayesian reanalysis showed moderate evidence in favor of no differences between SpO2 targets (BF10 = 0.30) in death or major disability, but moderate evidence (BF10 = 3.60) in favor of a lower mortality in the higher SpO2 group. Evidence in favor of differences was observed for bronchopulmonary dysplasia (BPD) (BF10 = 14.44, lower rate with lower SpO2), severe NEC (BF10 = 9.94), and treated ROP (BF10 = 3.36). The only outcome with moderate evidence in favor of sex differences was BPD. This reanalysis of the NeOProM trials confirmed that exposure to a lower versus higher SpO2 range is associated with a higher mortality and risk of NEC, but a lower risk of ROP and BPD. The Bayesian approach can help in assessing the strength of evidence supporting clinical decisions.

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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.

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INTRODUCTION: The evaluation of pulp status is crucial for avulsed immature permanent teeth after replantation. In addition to commonly used clinical and radiographic examinations providing clinical evidence, the oxygen saturation test may offer valuable assistance. The aim of this study was to analyze the efficacy of a pulse oximeter in evaluating pulp status in avulsed and replanted immature permanent teeth. METHODS: A prospective observational study was performed including 51 avulsed and replanted immature permanent teeth. Routine clinical and radiographic examinations were performed and used as the basis for the diagnosis of pulp status during the 1-year follow-up period. Meanwhile, the oxygen saturation values of these teeth were recorded using a modified pulse oximeter at each visit. RESULTS: Seven teeth completed pulp revascularization (success group), whereas 44 teeth failed to revascularize (failure group). Abnormal clinical and/or radiographic manifestations in the failure group were observed at an average period of 42.7 days, which was too late because a high incidence of inflammatory root resorption (43.18%) had occurred. For oxygen saturation tests, teeth in the success group showed an immediate postreplantation oxygen value of 70.71 ± 3.35, then an upward trend starting from the 2-week postreplantation visit, and a significantly increased final value of 81.86 ± 2.34 at the 1-year visit. In contrast, no increase trend was found for teeth in the failure group because abnormal clinical and/or radiographic manifestations emerged. CONCLUSIONS: The oxygen saturation test is a reliable diagnostic method to evaluate pulp status of avulsed teeth as early as 2 weeks after replantation.

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In this article, a patient monitoring system is proposed that is able to obtain heart rate and oxygen saturation (SpO2) levels of patients, identify abnormal conditions, and inform emergency status to the nurses. The proposed monitoring system consists of smart patient wristbands, smart nurse wristbands, central monitoring user interface (UI) software, and a wireless communication network. In the proposed monitoring system, a unique smart wristband is dedicated to each of the patients and nurses. To measure heart rate and SpO2 level, a pulse oximeter sensor is used in the patient wristbands. The output of this sensor is transferred to the wristband's microcontroller where heart rate and SpO2 are calculated through advanced signal processing algorithms. Then, the calculated values are transmitted to central UI software through a wireless network. In the UI software, received values are compared with their normal values and a predefined message is sent to the nurses' wristband if an abnormal condition is identified. Whenever this message is received by a nurse's wristband, an acoustic alarm with vibration is generated to inform an emergency status to the nurse. By doing so, health services are delivered to the patients more quickly and as a result, the probability of the patient recovery is increased effectively.

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BACKGROUND: Fingertip pulse oximeters are widely available, inexpensive, and commonly used to make clinical decisions in many settings. Device performance is largely unregulated and poorly characterised, especially in people with dark skin pigmentation. METHODS: Eleven popular fingertip pulse oximeters were evaluated using the US Food and Drug Administration (FDA) Guidance (2013) and International Organization for Standardization Standards (ISO, 2017) in 34 healthy humans with diverse skin pigmentation utilising a controlled desaturation study with arterial oxygen saturation (SaO 2) plateaus between 70% and 100%. Skin pigmentation was assessed subjectively using a perceived Fitzpatrick Scale (pFP) and objectively using the individual typology angle (ITA) via spectrophotometry at nine anatomical sites. FINDINGS: Five of 11 devices had a root mean square error (ARMS) > 3%, falling outside the acceptable FDA performance range. Nine devices demonstrated worse performance in participants in the darkest skin pigmentation category compared with those in the lightest category. A commonly used subjective skin colour scale frequently miscategorised participants as being darkly pigmented when compared to objective quantification of skin pigment by ITA. INTERPRETATION: Fingertip pulse oximeters have variable performance, frequently not meeting regulatory requirements for clinical use, and occasionally contradicting claims made by manufacturers. Most devices showed a trend toward worse performance in participants with darker skin pigment. Regulatory standards do not adequately account for the impact of skin pigmentation on device performance. We recommend that the pFP and other non-standardised subjective skin colour scales should no longer be used for defining diversity of skin pigmentation. Reliable methods for characterising skin pigmentation to improve diversity and equitable performance of pulse oximeters are needed. FUNDING: This study was conducted as part of the Open Oximetry Project funded by the Gordon and Betty Moore Foundation, Patrick J McGovern Foundation, and Robert Wood Johnson Foundation. The UCSF Hypoxia Research Laboratory receives funding from multiple industry sponsors to test the sponsors' devices for the purposes of product development and regulatory performance testing. Data in this paper do not include sponsor's study devices. All data were collected from devices procured by the Hypoxia Research Laboratory for the purposes of independent research. No company provided any direct funding for this study, participated in study design or analysis, or was involved in analysing data or writing the manuscript. None of the authors own stock or equity interests in any pulse oximeter companies. Dr Ellis Monk's time utilised for data analysis, reviewing and editing was funded by grant number: DP2MH132941.

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OBJECTIVES: To describe the prevalence of Owlet Smart Sock (OSS) use in infants with supraventricular tachycardia (SVT) and associated demographic and clinical characteristics of users and to analyze the association of OSS use on medical resource use and clinical outcomes from emergency department (ED) encounters for SVT. STUDY DESIGN: This was a single-center, retrospective cohort study of infants with confirmed SVT from 2015 to 2022. OSS users and nonusers were compared across clinical and demographic parameters. Medical resource use (phone calls, office visits, ED visits) and outcomes (need for intensive care, length of stay, echocardiographic function, clinical appearance) were compared between OSS users and nonusers. RESULTS: Of 133 infants with SVT, OSS was used by 31 of 133 (23%), purchased before SVT diagnosis in 5 in 31 (16%) of users. No demographic difference was found between OSS users and nonusers. OSS users had more phone notes than nonusers, (P = .002) and more ED visits (P = .03), but the number of office visits and medication adjustments did not differ. During ED presentation, OSS users had better preserved left ventricular ejection fraction on echocardiogram (P = .04) and lower length of hospital stay by a mean 1.7 days (P = .02). CONCLUSIONS: OSS is used by a portion of infants with SVT. It is associated with more frequent phone calls and ED visits but lower length of stay and better-preserved cardiac function upon presentation.

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The monitoring of oxygen therapy when patients are admitted to medical and surgical wards could be important because exposure to excessive oxygen administration (EOA) may have fatal consequences. We aimed to investigate the association between EOA, monitored by wireless pulse oximeter, and nonfatal serious adverse events (SAEs) and mortality within 30 days. We included patients in the Capital Region of Copenhagen between 2017 and 2018. Patients were hospitalized due to acute exacerbation of chronic obstructive pulmonary disease (AECOPD) or after major elective abdominal cancer surgery, and all were treated with oxygen supply. Patients were divided into groups by their exposure to EOA: no exposure, exposure for 1-59 min or exposure over 60 min. The primary outcome was SAEs or mortality within 30 days. We retrieved data from 567 patients for a total of 43,833 h, of whom, 63% were not exposed to EOA, 26% had EOA for 1-59 min and 11% had EOA for ≥60 min. Nonfatal SAEs or mortality within 30 days developed in 24%, 12% and 22%, respectively, and the adjusted odds ratio for this was 0.98 (95% CI, 0.96-1.01) for every 10 min. increase in EOA, without any subgroup effects. In conclusion, we did not observe higher frequencies of nonfatal SAEs or mortality within 30 days in patients exposed to excessive oxygen administration.

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