Origins of Racial and Ethnic Bias in Pulmonary Technologies.

Understanding how biases originate in medical technologies and developing safeguards to identify, mitigate, and remove their harms are essential to ensuring equal performance in all individuals. Drawing upon examples from pulmonary medicine, this article describes how bias can be introduced in the physical aspects of the technology design, via unrepresentative data, or by conflation of biological with social determinants of health. It then can be perpetuated by inadequate evaluation and regulatory standards. Research demonstrates that pulse oximeters perform differently depending on patient race and ethnicity. Pulmonary function testing and algorithms used to predict healthcare needs are two additional examples of medical technologies with racial and ethnic biases that may perpetuate health disparities.

Pulse oximetry for the prediction of acute mountain sickness: A systematic review.

Acute mountain sickness (AMS) causes serious illness for many individuals ascending to high altitude (HA), although preventable with appropriate acclimatisation. AMS is a clinical diagnosis, with symptom severity evaluated using the Lake Louise Score (LLS). Reliable methods of predicting which individuals will develop AMS have not been developed. This systematic review evaluates whether a predictive relationship exists between oxygen saturation and subsequent development of AMS. PubMed, PubMed Central, MEDLINE, Semantic Scholar, Cochrane Library, University of Birmingham Library and clinicaltrials.gov databases were systematically searched from inception to 15 June 2023. Human studies involving collection of peripheral blood oxygen saturation ( S p O 2 ${{S}_{{\mathrm{p}}{{{\mathrm{O}}}_{\mathrm{2}}}}}$ ) from healthy lowlanders during ascent to HA that evaluated any relationship between S p O 2 ${{S}_{{\mathrm{p}}{{{\mathrm{O}}}_{\mathrm{2}}}}}$ and AMS severity were considered for eligibility. Risk of bias was assessed using a modified Newcastle-Ottawa Tool for cohort studies (PROPSPERO CRD42023423542). Seven of 980 total identified studies were ultimately included for data extraction. These studies evaluated S p O 2 ${{S}_{{\mathrm{p}}{{{\mathrm{O}}}_{\mathrm{2}}}}}$ and AMS (via LLS) in 1406 individuals during ascent to HA (3952-6300 m). Risk of bias was 'low' for six and 'moderate' for one of the included studies. Ascent profiles and S p O 2 ${{S}_{{\mathrm{p}}{{{\mathrm{O}}}_{\mathrm{2}}}}}$ measurement methodology varied widely, as did the statistical methods for AMS prediction. Decreasing oxygen saturation measured with pulse oximetry during ascent shows a positive predictive relationship for individuals who develop AMS. Studies have high heterogeneity in ascent profile and oximetry measurement protocols. Further studies with homogeneous methodology are required to enable statistical analysis for more definitive evaluation of AMS predictability by pulse oximetry.

The effect of longitudinal sleep monitoring on clinician agreement in obstructive sleep apnea diagnosis: The ELSA study.

There is strong evidence for clinically relevant night-to-night variability of respiratory events in patients with suspected obstructive sleep apnea. Sleep experts retrospectively evaluated diagnostic data in 56 patients with suspected obstructive sleep apnea. Experts were blinded to the fact that they were diagnosing the same case twice, once based on a short report of a single in-laboratory respiratory polygraphy and once with the additional information of 14 nights of pulse oximetry at home. All experts (n = 22) were highly qualified, 13 experts (59.1%) treated > 100 patients with suspected obstructive sleep apnea per year. In 12 patients, the apnea-hypopnea index in the respiratory polygraphy was < 5 per hr, but the mean oxygen desaturation index of 14 nights of pulse oximetry was ≥ 5 per hr. The additional information of 14 nights of pulse oximetry helped to diagnose obstructive sleep apnea with a 70% consensus in two of those patients (16.7% [95% confidence interval: 4.7/44.8]). In eight patients, experts could not agree to a 70% consensus regarding continuous positive airway pressure therapy recommendation after respiratory polygraphy. The additional information of multiple-night testing led to a consensus in three of those cases (37.5% [95% confidence interval: 14/69]). Change of obstructive sleep apnea diagnosis and continuous positive airway pressure recommendation was significantly negatively associated with the number of treated obstructive sleep apnea patients > 100 per year compared with 0-29 patients per year (Coef. [95% confidence interval] -0.63 [-1.22/-0.04] and -0.61 [-1.07/-0.15], respectively). Experts found already a high level of consensus regarding obstructive sleep apnea diagnosis, severity and continuous positive airway pressure recommendation after a single respiratory polygraphy. However, longitudinal sleep monitoring could help increase consensus in selected patients with diagnostic uncertainty.

Newborn pulse oximetry screening coverage in a nationwide complex survey sample: An assessment of a congenital heart disease early detection program at the regional level in Brazil.

OBJECTIVES: To estimate the coverage of newborn pulse oximetry screening (POS) in Brazil, as well as identifies associated factors and the proportion of positive screening results. METHODS: Coverage was estimated based on the most recent National Health Survey (2019). Adjusted marginal prevalence ratios were estimated via poisson regression model with robust variance. RESULTS: The POS coverage was 66.3 % (95 %CI: 65.5-67.1; N = 3,140,023) and was higher in children born in privately funded hospitals (PFHs) than in the Unified Health System (SUS): 78.1 % (76.7-79.5) versus 61.1 % (60.2-62.1). In the North region, the POS coverage in PFHs (64.9 %, 59.7-70.1) was lower than that in the South (82.5 %, 79.4-85.6) and the Southeast (81.5 %, 79.3-83.6); it was even lower in SUS in the North (44.0 %; 42.4-45.6). After a federal ordinance providing financial resources to postscreening diagnostic, the screening coverage in SUS increased from 57.6 % (56.2-59.1) to 64.6 % (63.3-65.9). The proportion of positive screening tests was 9.2 % (8.9-9.5) in SUS and 7.8 % (7.3-8.3) in PFHs, of which 40.8 % (40.5-41.1) underwent complementary exams in SUS and 57.2 % (56.7-57.7) in PFHs. In the multivariate model, the main independent predictors of POS were the coverage of other newborn screening tests. CONCLUSIONS: Inequalities were found between major regions and healthcare systems. Government financial incentives have reduced this inequality, although the percentage of postscreening complementary exams remains insufficient and unequal. The main independent predictors of screening prevalence were those related to the organization of health services.

Oxygen saturation thresholds in managing sickle cell disease at US children's hospitals.

BACKGROUND: Adequate oxygen saturation (SpO2 ) is crucial for managing sickle cell disease (SCD). Children with SCD are at increased risk for occult hypoxemia; therefore, understanding SpO2 threshold practices would help identify barriers to oxygen optimization in a population sensitive to oxyhemoglobin imbalances. We investigated SpO2 cutoff levels used in clinical algorithms for management of acute SCD events at children's hospitals across the United States, and determined their consistency with recommended national guidelines (SpO2  > 95%). METHODS: Clinical pathways and algorithms used for the management of vaso-occlusive crisis (VOC) and acute chest syndrome (ACS) in SCD were obtained and reviewed from large children's hospitals in the United States. RESULTS: Responses were obtained from 94% (140/149) of eligible children's hospitals. Of these, 63 (45%) had available clinical algorithms to manage VOC and ACS. SpO2 cutoff was provided in 71.4% (45/63) of clinical algorithms. Substantial variation in SpO2 cutoff levels was noted, ranging from ≥90% to more than 95%. Only seven hospitals (5% of total hospitals and 15.6% of hospitals with clinical algorithms available) specified oxygen cutoffs that were consistent with national guidelines. Hospitals geographically located in the South (46.8%; n = 29/62) and Midwest (54.8%; n = 17/31) were more likely to have VOC and ACS clinical algorithms, compared to the Northeast (26.5%; n = 9/34) and West (36.4%; n = 8/22). CONCLUSION: There is inconsistency in the use of clinical algorithms and oxygen thresholds for VOC and ACS across US children's hospitals. Children with SCD could be at risk for insufficient oxygen therapy during adverse acute events.

Pulse oximetry in patients with pigmented skin: What I should know.

Pulse oximetry is widely used to non-invasively estimate the oxygen saturation of haemoglobin in arterial blood (SpO2). It is used widely throughout healthcare and was used extensively during the Covid-19 pandemic to detect and treat hypoxic patients. Research has suggested that pulse oximetry is less accurate in patients with darker skin. This led the US Food and Drug Administration agency (FDA) to issue a safety statement warning that pulse oximeters may be inaccurate when patients have pigmented skin. Evidence suggests that the oxygen saturation of arterial blood (SaO2) may be being overestimated by measuring SpO2 in those with pigmented skin. The degree of overestimation increases as SaO2 decreases especially when SpO2 reads below 80%. We review how pulse oximetry works and consider the implications for a patient's health when interpreting SpO2 in individuals with pigmented skin.

Melanin bias in pulse oximetry explained by light source spectral bandwidth.

BACKGROUND: Pulse oximetry uses noninvasive optical measurements of light transmission from each of two sources through vascularised living tissue over the cardiac cycle (SpO2). From those measurements, the relative amount of oxygenated haemoglobin (SaO2) in circulating blood can be deduced. Recent reports have shown that, compared with SaO2 measurements from blood samples, SpO2 measurements are biased erroneously high for patients with dark skin. METHODS: We developed a new method, spectrally resolved photoplethysmography (srPPG), to examine how spectral bandwidth affects the transmission of polychromatic light through the fingertip across the cardiac cycle. We measured and recorded the spectral transmission through the fingertip as the O2 concentration in inspired air was reduced. We applied digital spectral filters of two different bandwidths, narrow or broad, to the same srPPG recordings to determine whether SpO2 readings systematically varied for the two bandwidths. The srPPG method also allowed us to measure the fractional amount of melanin in the optical path. The effect of melanin content on the ratio of SpO2 readings for narrow and broad spectral bandwidths was analysed. RESULTS: We hypothesised, based upon the Beer-Lambert law, and then showed experimentally, that the light emission spectra of light-emitting diode light sources, as used in commercial pulse oximeters, result in erroneously high SpO2 measurements for patients having greater melanin concentrations in their skin than those of the subject pool used for instrument calibration. CONCLUSIONS: To eliminate melanin bias, pulse oximeters should use much narrower spectral bandwidths than those used in current models.

Pulse oximetry signal loss during hypoxic episodes in preterm infants receiving automated oxygen control.

The aim of this study was to analyze signal loss (SL) resulting from low signal quality of pulse oximetry-derived hemoglobin oxygen saturation (SpO2) measurements during prolonged hypoxemic episodes (pHE) in very preterm infants receiving automatic oxygen control (AOC). We did a post hoc analysis of a randomized crossover study of AOC, programmed to set FiO2 to "back-up FiO2" during SL. In 24 preterm infants (median (interquartile range)) gestational age 25.3 (24.6 to 25.6) weeks, recording time 12.7 h (12.2 to 13.6 h) per infant, we identified 76 pHEs (median duration 119 s (86 to 180 s)). In 50 (66%) pHEs, SL occurred for a median duration of 51 s (33 to 85 s) and at a median frequency of 2 (1 to 2) SL-periods per pHE. SpO2 before and after SL was similar (82% (76 to 88%) vs 82% (76 to 87%), p = 0.3)).  Conclusion: SL is common during pHE and must hence be considered in AOC-algorithm designs. Administering a "backup FiO2" (which reflects FiO2-requirements during normoxemia) during SL may prolong pHE with SL.  Trial registration: The study was registered at www. CLINICALTRIALS: gov under the registration no. NCT03785899. WHAT IS KNOWN: • Previous studies examined SpO2 signal loss (SL) during routine manual oxygen control being rare, but pronounced in lower SpO2 states. • Oxygen titration during SL is unlikely to be beneficial as SpO2 may recover to a normoxic range. WHAT IS NEW: • Periods of low signal quality of SpO2 are common during pHEs and while supported with automated oxygen control (SPOC), FiO2 is set to a back-up value reflecting FiO2 requirements during normoxemia in response to SL, although SpO2 remained below target until signal recovery. • FiO2 overshoots following pHEs were rare during AOC and occurred with a delayed onset; therefore, increased FiO2 during SL does not necessarily lead to overshoots.

Characterizing the Racial Discrepancy in Hypoxemia Detection in Venovenous Extracorporeal Membrane Oxygenation: An Extracorporeal Life Support Organization Registry Analysis.

PURPOSE: Skin pigmentation influences peripheral oxygen saturation (SpO2) compared to arterial saturation of oxygen (SaO2). Occult hypoxemia (SaO2 ≤ 88% with SpO2 ≥ 92%) is associated with increased in-hospital mortality in venovenous-extracorporeal membrane oxygenation (VV-ECMO) patients. We hypothesized VV-ECMO cannulation, in addition to race/ethnicity, accentuates the SpO2-SaO2 discrepancy due to significant hemolysis. METHODS: Adults (≥ 18 years) supported with VV-ECMO with concurrently measured SpO2 and SaO2 measurements from over 500 centers in the Extracorporeal Life Support Organization Registry (1/2018-5/2023) were included. Multivariable logistic regressions were performed to examine whether race/ethnicity was associated with occult hypoxemia in pre-ECMO and on-ECMO SpO2-SaO2 calculations. RESULTS: Of 13,171 VV-ECMO patients, there were 7772 (59%) White, 2114 (16%) Hispanic, 1777 (14%) Black, and 1508 (11%) Asian patients. The frequency of on-ECMO occult hypoxemia was 2.0% (N = 233). Occult hypoxemia was more common in Black and Hispanic patients versus White patients (3.1% versus 1.7%, P < 0.001 and 2.5% versus 1.7%, P = 0.025, respectively). In multivariable logistic regression, Black patients were at higher risk of pre-ECMO occult hypoxemia versus White patients (adjusted odds ratio [aOR] = 1.55, 95% confidence interval [CI] = 1.18-2.02, P = 0.001). For on-ECMO occult hypoxemia, Black patients (aOR = 1.79, 95% CI = 1.16-2.75, P = 0.008) and Hispanic patients (aOR = 1.71, 95% CI = 1.15-2.55, P = 0.008) had higher risk versus White patients. Higher pump flow rates (aOR = 1.29, 95% CI = 1.08-1.55, P = 0.005) and on-ECMO 24-h lactate (aOR = 1.06, 95% CI = 1.03-1.10, P < 0.001) significantly increased the risk of on-ECMO occult hypoxemia. CONCLUSION: SaO2 should be carefully monitored if using SpO2 during ECMO support for Black and Hispanic patients especially for those with high pump flow and lactate values at risk for occult hypoxemia.

Early screening of sleep disordered breathing in hospitalized stroke patients high-resolution pulse oximetry as prognostic and early intervention tools in patients with acute stroke and sleep apnea (HOPES TRIAL).

INTRODUCTION: Sleep Disordered Breathing (SDB) has been shown to increase the risk of stroke and despite recommendations, routine evaluation for SDB in acute stroke is not consistent across institutions. The necessary logistics and expertise required to conduct sleep studies in hospitalized patients remain a significant barrier. This study aims to evaluate the feasibility of high-resolution pulse-oximetry (HRPO) for the screening of SDB in acute stroke. Secondarily, considering impact of SDB on acute stroke, we investigated whether SDB at acute stroke predicts functional outcome at discharge and at 3 months post-stroke. METHODS: Patients with acute mild to moderate ischemic stroke underwent an overnight HRPO within 48 h of admission. Patients were divided into SDB and no-SDB groups based on oxygen desaturations index(ODI > 10/h). Stepwise multivariate logistic regression analysis was applied to identify the relevant predictors of functional outcome (favorable [mRS 1-2 points] versus unfavorable [mrS > = 3 points]). RESULTS: Of the 142 consecutively screened patients, 96 were included in the analysis. Of these, 33/96 (34%) were identified as having SDB and were more likely to have unfavorable mRS scores as compared to those without SDB (odds ratio = 2.70, p-value = 0.032). CONCLUSION: HRPO may be a low-cost and easily administered screening method to detect SDB among patients hospitalized for acute ischemic stroke. Patients with SDB (as defined by ODI) have a higher burden of neurological deficits as compared to those without SDB during hospitalization.

Inter-night variability of in-home, overnight pulse oximetry screening in an asymptomatic older adult population.

PURPOSE: Obstructive sleep apnoea (OSA) is common, yet often undiagnosed. Self-administered, overnight pulse oximetry (OPO) could screen for OSA in asymptomatic, older populations. However, the inter-night variability of OPO in an asymptomatic, older population is unknown. We determined the inter-night variability of home OPO parameters in an older population and correlated with sleep questionnaires. METHODS: Participants > 50 years without a diagnosis of OSA undertook home OPO for three consecutive nights and completed two sleep questionnaires (STOP-BANG (SBQ) and Epworth Sleepiness Score (ESS)). Analysis was performed with linear mixed models and Spearman's correlation coefficient. RESULTS: There was no difference in oxygen desaturation index (ODI), MeanSpO2, MinimumSpO2, and time spent with SpO2 < 90% (T90) across two or three nights (P ≥ 0.282). However, the variability of all parameters across nights increased with the magnitude of departure from normal values (P ≤ 0.002). All OPO parameters were associated with age (P ≤ 0.034) and body mass index (P ≤ 0.049). There was a weak correlation between three OPO parameters and SBQ (absolute ρ = 0.22 to 0.32; P ≤ 0.021), but not ESS (P ≥ 0.254). CONCLUSION: Inter-night variability of home OPO was minimal when values were near-normal in an older population. However, as values depart from normal, the inter-night variability increases, indicating the need for multiple night recordings. Low correlation to sleep questionnaires suggest the need for more robust OSA questionnaires in an asymptomatic population.

Nocturnal hypoxia and age-related macular degeneration.

BACKGROUND: Nocturnal hypoxia is common, under-diagnosed and is found in the same demographic at risk of age-related macular degeneration (AMD). The objective of this study was to determine any association between nocturnal hypoxia and AMD, its severity, and the high-risk sub-phenotype of reticular pseudodrusen (RPD). METHODS: This cross-sectional study included participants aged ≥50 years with AMD, or normal controls, exclusive of those on treatment for obstructive sleep apnoea. All participants had at home, overnight (up to 3 nights) pulse oximetry recordings and multimodal imaging to classify AMD. Classification of Obstructive Sleep Apnea (OSA) was determined based on oxygen desaturation index [ODI] with mild having values of 5-15 and moderate-to-severe >15. RESULTS: A total of 225 participants were included with 76% having AMD, of which 42% had coexistent RPD. Of the AMD participants, 53% had early/intermediate AMD, 30% had geographic atrophy (GA) and 17% had neovascular AMD (nAMD). Overall, mild or moderate-to-severe OSAwas not associated with an increased odds of having AMD nor AMD with RPD (p ≥ 0.180). However, moderate-to-severe OSA was associated with increased odds of having nAMD (odds ratio = 6.35; 95% confidence interval = 1.18 to 34.28; p = 0.032), but not early/intermediate AMD or GA, compared to controls (p ≥ 0.130). Mild OSA was not associated with differences in odds of having AMD of any severity (p ≥ 0.277). CONCLUSIONS: There was an association between nocturnal hypoxia as measured by the ODI and nAMD. Hence, nocturnal hypoxia may be an under-appreciated important modifiable risk factor for nAMD.

Comparative analysis of videofluoroscopy and pulse oximetry for aspiration identification in patients with dysphagia after stroke and non-dysphagics.

PURPOSE: Dysphagia is a prevalent symptom observed in acute stroke. Several bedside screening tests are employed for the early detection of dysphagia. Pulse oximetry emerges as a practical and supportive method to augment the existing techniques utilized during bedside swallowing assessments. Desaturation levels, as measured by pulse oximetry, are acknowledged as indicative of aspiration by certain screening tests. However, the predictive capability of pulse oximetry in determining aspiration remains a subject of controversy. The objective of this study was to compare aspiration and oxygen desaturation levels by time and aspiration severity in dysphagic patients compared to healthy controls. It also aimed to evaluate the accuracy of pulse oximetry by comparing it with VFSS findings in detecting aspiration in both liquid (IDDSI-0) and semi-solid (IDDSI-4) consistencies. MATERIALS AND METHODS: Eighty subjects (40 healthy and 40 acute stroke patients) participated. Patients suspected of dysphagia underwent videofluoroscopy as part of the stroke unit's routine procedure. Baseline SpO2 was measured before VFSS, and stabilized values were recorded. Sequential IDDSI-0 and IDDSI-4 barium tests were conducted with 5 ml boluses. Stabilized SPO2 values were recorded during swallowing and 3-min post-feeding. Patients with non-dysphagia received equal bolus monitoring. Changes in SPO2 during, before, and after swallowing were analyzed for each consistency in both groups. RESULTS: The study revealed a statistically significant difference in SPO2 between patients with dysphagia and controls for IDDSI-4 and IDSSI-0. In IDDSI-4, 20% of patients experienced SpO2 decrease compared to 2.5% in control group (p = 0.013). For IDDSI-0, 35% of patients showed SpO2 decrease, while none in the control group did (p = 0.0001). Aspiration rates were 2.5% in IDDSI-4 and 57.5% in IDDSI-0. In IDDSI-0, SpO2 decrease significantly correlated with aspiration (p = 0.0001). In IDDSI-4, 20.5% had SpO2 decrease without aspiration, and showing no significant difference (p = 0.613). Penetration-Aspiration Scale scores had no significant association with SpO2 decrease (p = 0.602). Pulse oximetry in IDDSI-4 had limited sensitivity (0%) and positive predictive value, (0%) while in IDDSI-0, it demonstrated acceptable sensitivity (60.9%) and specificity (100%) with good discrimination capability (AUC = 0.83). CONCLUSIONS: A decrease in SPO2 may indicate potential aspiration but is insufficient alone for detection. This study proposes pulse oximetry as a valuable complementary tool in assessing dysphagia but emphasizes that aspiration cannot be reliably predicted based solely on SpO2 decrease.

Physiologic oxygen responses to smoking opioids: an observational study using continuous pulse oximetry at overdose prevention services in British Columbia, Canada.

BACKGROUND: In British Columbia, Canada, smoking is the most common modality of drug use among people who die of opioid toxicity. We aimed to assess oxygen saturation (SpO2) while people smoked opioids during a pilot study that introduced continuous pulse oximetry at overdose prevention services (OPS) sites. METHODS: This was an observational cohort study, using a participatory design. We implemented our monitoring protocol from March to August 2021 at four OPS. We included adults (≥ 18 years) presenting to smoke opioids. A sensor taped to participants' fingers transmitted real-time SpO2 readings to a remote monitor viewed by OPS staff. Peer researchers collected baseline data and observed the timing of participants' inhalations. We analyzed SpO2 on a per-event basis. In mixed-effects logistic regression models, drop in minimum SpO2 ≤ 90% in the current minute was our main outcome variable. Inhalation in that same minute was our main predictor. We also examined inhalation in the previous minute, cumulative inhalations, inhalation rate, demographics, co-morbidities, and substance use variables. RESULTS: We recorded 599 smoking events; 72.8% (436/599) had analyzable SpO2 data. Participants' mean age was 38.6 years (SD 11.3 years) and 73.1% were male. SpO2 was highly variable within and between individuals. Drop in SpO2 ≤ 90% was not significantly associated with inhalation in that same minute (OR: 1.2 [0.8-1.78], p = 0.261) or inhalation rate (OR 0.47 [0.20-1.10], p = 0.082). There was an association of SpO2 drop with six cumulative inhalations (OR 3.38 [1.04-11.03], p = 0.043); this was not maintained ≥ 7 inhalations. Demographics, co-morbidities, and drug use variables were non-contributory. CONCLUSIONS: Continuous pulse oximetry SpO2 monitoring is a safe adjunct to monitoring people who smoke opioids at OPS. Our data reflect challenges of real-world monitoring, indicating that greater supports are needed for frontline responders at OPS. Inconsistent association between inhalations and SpO2 suggests that complex factors (e.g., inhalation depth/duration, opioid tolerance, drug use setting) contribute to hypoxemia and overdose risk while people smoke opioids.

Estimation of the inferior caval vein saturation using high-fidelity non-invasive haemodynamic values and validation of modelled estimates.

OBJECTIVES: Monitoring venous saturation allows identification of inadequate systemic oxygen delivery. The aim was to develop a model using non-invasive haemodynamic variables to estimate the inferior caval vein saturation and to determine its prognostic utility. METHODS: This is a single-centre, retrospective study. A Bayesian Pearson's correlation was conducted to model the inferior caval vein saturation. Next, a Bayesian linear regression was conducted for data from all the patients and from only those with parallel circulation. Venous saturation estimations were developed. The correlation of these estimates to the actual inferior caval vein saturation was assessed. The resulting models were then applied to two validation cohorts: biventricular circulation (arterial switch operation) and parallel circulation (Norwood operation). RESULTS: One hundred and thirteen datasets were collected across 15 patients. Of which, 65% had parallel circulation. In all patients, the measured and estimated inferior caval vein saturations had a moderate and significant correlation with a coefficient of 0.64. In patients with parallel circulation, the measured and estimated inferior caval vein saturation had a moderate and significant correlation with a coefficient of 0.61. In the biventricular circulation cohort, the estimated inferior caval vein saturation had an area under the curve of 0.71 with an optimal cut-off of 49. In the parallel circulation cohort, the estimated interior caval vein saturation had an area under the curve of 0.83 with an optimal cut-off of 24%. CONCLUSION: The inferior caval vein saturation can be estimated utilising non-invasive haemodynamic data. This estimate has correlation with measured inferior caval vein saturations and offers prognostic utility.

Effect of Skin Pigmentation and Finger Choice on Accuracy of Oxygen Saturation Measurement in an IoT-Based Pulse Oximeter.

Pulse oximeters are widely used in hospitals and homes for measurement of blood oxygen saturation level (SpO2) and heart rate (HR). Concern has been raised regarding a possible bias in obtaining pulse oximeter measurements from different fingertips and the potential effect of skin pigmentation (white, brown, and dark). In this study, we obtained 600 SpO2 measurements from 20 volunteers using three UK NHS-approved commercial pulse oximeters alongside our custom-developed sensor, and used the Munsell colour system (5YR and 7.5YR cards) to classify the participants' skin pigmentation into three distinct categories (white, brown, and dark). The statistical analysis using ANOVA post hoc tests (Bonferroni correction), a Bland-Altman plot, and a correlation test were then carried out to determine if there was clinical significance in measuring the SpO2 from different fingertips and to highlight if skin pigmentation affects the accuracy of SpO2 measurement. The results indicate that although the three commercial pulse oximeters had different means and standard deviations, these differences had no clinical significance.

The Development of a Measuring System for Intraoral SpO2.

Blood oxygen saturation (SpO2) is an essential indicator of a patient's general condition. However, conventional measurement methods have some issues such as time delay and interference by ambient light. Improved measurement methods must be developed, and there are no reports on intraoral measurements of SpO2 using wearable devices. Therefore, we aimed to establish an intraoral SpO2 measurement method for the first time. Twelve healthy adults participated in this study. The following steps were taken: (1) to identify the optimal measurement location, mid-perfusion index (PI) values were measured at six places on the mucosa of the maxilla, (2) to validate the optimal measurement pressure, PI values were obtained at different pressures, and (3) using the proposed mouthpiece device, SpO2 values in the oral cavity and on the finger were analyzed during breath-holding. The highest PI values were observed in the palatal gingiva of the maxillary canine teeth, with high PI values at pressures ranging from 0.3 to 0.8 N. In addition, changes in SpO2 were detected approximately 7 s faster in the oral cavity than those on the finger, which is attributed to their proximity to the heart. This study demonstrates the advantage of the oral cavity for acquiring biological information using a novel device.

Assessment of skin pigmentation-related bias in pulse oximetry readings among adults.

PURPOSE: Recent reports that pulse oximeters may overestimate oxygen saturation in individuals with darker skin pigmentation have prompted concerns from regulatory authorities regarding racial bias. We investigated the performance of TruSignal SpO2 sensors (GE Healthcare, Helsinki, Finland) in adults with varying skin pigmentation. METHODS: A retrospective study was conducted using a set of pooled assessments of SpO2/SaO2 measurements from nine studies to assess bias, accuracy (Arms), and precision of TruSignal sensors in healthy adults under induced hypoxia. Subgroup analyses were performed based on oxygen saturation levels (band 1, ≥ 70 and ≤ 80%; band 2, > 80 and ≤ 90%; band 3, > 90 and ≤ 100%). RESULTS: Of the 10,800 data points from 131 individuals, 8,202 (75.9%) and 2,598 (24.1%) were assigned to the light and dark pigment groups, respectively. Bias was 0.14% overall and less than 1% across oxygenation bands. The difference in bias between dark and light pigment groups was statistically significant at the low oxygenation band with SpO2 ≥ 70 and ≤ 80% (+ 0.58% and + 0.30% respectively; p = 0.0035). Throughout the saturation range, Arms was 1.64% in the light and 1.71% in the dark pigment group, within device specifications and regulatory requirements. Oxygenation was the dominating factor in stepwise ANOVA modeling. The mixed model also showed that bias was strongly affected by the oxygenation range. CONCLUSION: TruSignal sensors demonstrated higher bias at lower oxygen saturation, with less than 0.5% difference between pigment groups. These findings raise new questions, such as ways to improve pulse oximetry measurements during challenging clinical conditions, including low perfusion.

Electronic health record data is unable to effectively characterize measurement error from pulse oximetry: a simulation study.

Large data sets from electronic health records (EHR) have been used in journal articles to demonstrate race-based imprecision in pulse oximetry (SpO2) measurements. These articles do not appear to recognize the impact of the variability of the SpO2 values with respect to time ("deviation time"). This manuscript seeks to demonstrate that due to this variability, EHR data should not be used to quantify SpO2 error. Using the MIMIC-IV Waveform dataset, SpO2 values are sampled from 198 patients admitted to an intensive care unit and used as reference samples. The error derived from the EHR data is simulated using a set of deviation times. The laboratory oxygen saturation measurements are also simulated such that the performance of three simulated pulse oximeter devices will produce an average root mean squared (ARMS) error of 2%. An analysis is then undertaken to reproduce a medical device submission to a regulatory body by quantifying the mean error, the standard deviation of the error, and the ARMS error. Bland-Altman plots were also generated with their Limits of Agreements. Each analysis was repeated to evaluate whether the measurement errors were affected by increasing the deviation time. All error values increased linearly with respect to the logarithm of the time deviation. At 10 min, the ARMS error increased from a baseline of 2% to over 4%. EHR data cannot be reliably used to quantify SpO2 error. Caution should be used in interpreting prior manuscripts that rely on EHR data.

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.