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PloS One 2023Systemic Sclerosis in the hand is characteristically evidenced by Raynaud's phenomenon, fibrosis of the skin, tendons, ligaments, and joints as well as digital ulcers... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Systemic Sclerosis in the hand is characteristically evidenced by Raynaud's phenomenon, fibrosis of the skin, tendons, ligaments, and joints as well as digital ulcers with prolonged healing. Current medical treatment does not always cure these complications. Local adipose-derived stromal vascular fraction administration into the hands has been proposed as an emerging treatment due to its regenerative properties. The objective of this randomized controlled clinical trial was to evaluate the safety and clinical effects of fat micrografts plus adipose derived-stromal vascular fraction administration into the hands of patients with systemic sclerosis.
METHODS
This was an open-label, monocentric, randomized controlled study. Twenty patients diagnosed with systemic sclerosis were assigned to the experimental or control group. Fat micrografts plus the adipose derived-stromal vascular fraction were injected into the right hand of experimental group patients. The control group continued to receive only medical treatment. Demographic, serologic data and disease severity were recorded. Digital oximetry, pain, Raynaud phenomenon, digital ulcers number, mobility, thumb opposition, vascular density of the nail bed, skin affection of the hand, serologic antibodies, hand function, and quality of life scores were evaluated in both groups.
RESULTS
The results of the intervention were analyzed with the Wilcoxon rank test, and the differences between the control and experimental groups at 0 days and 168 days were analyzed with the Mann-Whitney U test. Adverse events were not observed in both groups. At the end of the study, statistically significant improvements were observed in pain levels (p<0.05) and number of digital ulcers (p<0.01) in the experimental vs control group.
CONCLUSION
The injection of adipose derived-stromal vascular fraction plus fat micrografts is a reproducible, and safe technique. Pain and digital ulcers in the hands of patients with systemic sclerosis can be treated with this technique plus conventional medical treatment.
Topics: Humans; Quality of Life; Stromal Vascular Fraction; Treatment Outcome; Scleroderma, Systemic; Adipose Tissue; Raynaud Disease
PubMed: 37578960
DOI: 10.1371/journal.pone.0289594 -
Nature Communications Aug 2023Obstructive sleep apnea (OSA) is a serious medical condition with a high prevalence, although diagnosis remains a challenge. Existing home sleep tests may provide...
Obstructive sleep apnea (OSA) is a serious medical condition with a high prevalence, although diagnosis remains a challenge. Existing home sleep tests may provide acceptable diagnosis performance but have shown several limitations. In this retrospective study, we used 12,923 polysomnography recordings from six independent databases to develop and evaluate a deep learning model, called OxiNet, for the estimation of the apnea-hypopnea index from the oximetry signal. We evaluated OxiNet performance across ethnicity, age, sex, and comorbidity. OxiNet missed 0.2% of all test set moderate-to-severe OSA patients against 21% for the best benchmark.
Topics: Humans; Retrospective Studies; Deep Learning; Sleep Apnea, Obstructive; Oximetry; Comorbidity
PubMed: 37573327
DOI: 10.1038/s41467-023-40604-3 -
Journal of the American Heart... Jun 2024Oxygen saturation (Spo) screening has not led to earlier detection of critical congenital heart disease (CCHD). Adding pulse oximetry features (ie, perfusion data and...
BACKGROUND
Oxygen saturation (Spo) screening has not led to earlier detection of critical congenital heart disease (CCHD). Adding pulse oximetry features (ie, perfusion data and radiofemoral pulse delay) may improve CCHD detection, especially coarctation of the aorta (CoA). We developed and tested a machine learning (ML) pulse oximetry algorithm to enhance CCHD detection.
METHODS AND RESULTS
Six sites prospectively enrolled newborns with and without CCHD and recorded simultaneous pre- and postductal pulse oximetry. We focused on models at 1 versus 2 time points and with/without pulse delay for our ML algorithms. The sensitivity, specificity, and area under the receiver operating characteristic curve were compared between the Spo-alone and ML algorithms. A total of 523 newborns were enrolled (no CHD, 317; CHD, 74; CCHD, 132, of whom 21 had isolated CoA). When applying the Spo-alone algorithm to all patients, 26.2% of CCHD would be missed. We narrowed the sample to patients with both 2 time point measurements and pulse-delay data (no CHD, 65; CCHD, 14) to compare ML performance. Among these patients, sensitivity for CCHD detection increased with both the addition of pulse delay and a second time point. All ML models had 100% specificity. With a 2-time-points+pulse-delay model, CCHD sensitivity increased to 92.86% (=0.25) compared with Spo alone (71.43%), and CoA increased to 66.67% (=0.5) from 0. The area under the receiver operating characteristic curve for CCHD and CoA detection significantly improved (0.96 versus 0.83 for CCHD, 0.83 versus 0.48 for CoA; both =0.03) using the 2-time-points+pulse-delay model compared with Spo alone.
CONCLUSIONS
ML pulse oximetry that combines oxygenation, perfusion data, and pulse delay at 2 time points may improve detection of CCHD and CoA within 48 hours after birth.
REGISTRATION
URL: https://www.clinicaltrials.gov/study/NCT04056104?term=NCT04056104&rank=1; Unique identifier: NCT04056104.
Topics: Humans; Oximetry; Heart Defects, Congenital; Infant, Newborn; Male; Female; Neonatal Screening; Machine Learning; Prospective Studies; Oxygen Saturation; Predictive Value of Tests; Algorithms; ROC Curve
PubMed: 38879455
DOI: 10.1161/JAHA.123.033786 -
JAMA Network Open Jun 2024Congenital heart disease (CHD) is the most common human organ malformation, affecting approximately 1 of 125 newborns globally.
IMPORTANCE
Congenital heart disease (CHD) is the most common human organ malformation, affecting approximately 1 of 125 newborns globally.
OBJECTIVES
Assessing the performance of 2 diagnostic tests using minimal amounts of dried blood spots (DBS) to identify high-risk CHD compared with controls in a Swedish cohort of neonates.
DESIGN, SETTING, AND PARTICIPANTS
This diagnostic study took place in Sweden between 2019 and 2023 and enrolled full-term babies born between 2005 and 2023. All cases were identified through centralized pediatric cardiothoracic surgical services in Lund and Gothenburg, Sweden. Controls were followed up for 1 year to ensure no late presentations of high-risk CHD occurred. Cases were verified through surgical records and echocardiography.
EXPOSURE
High-risk CHD, defined as cases requiring cardiac surgical management during infancy due to evolving signs of heart failure or types in which the postnatal circulation depends on patency of the arterial duct. Using 3-μL DBS samples, automated quantitative tests for NT-proBNP and interleukin 1 receptor-like 1 (IL-1 RL1; formerly known as soluble ST2) were compared against established CHD screening methods.
MAIN OUTCOMES AND MEASURES
Performance of DBS tests to detect high-risk CHD using receiver operating characteristic curves; Bland-Altman and Pearson correlation analyses to compare IL-1 RL1 DBS with plasma blood levels.
RESULTS
A total of 313 newborns were included (mean [SD] gestational age, 39.4 [1.3] weeks; 181 [57.8%] male). Mean (SD) birthweight was 3495 (483) grams. Analyzed DBS samples included 217 CHD cases and 96 controls. Among the CHD cases, 188 participants (89.3%) were high-risk types, of which 73 (38.8%) were suspected prenatally. Of the 188 high-risk cases, 94 (50.0%) passed pulse oximetry screening and 36 (19.1%) were initially discharged after birth without diagnoses. Combining NT-proBNP and IL-1 RL1 tests performed well in comparison with existing screening methods and enabled additional identification of asymptomatic babies with receiver operating characteristic area under the curve 0.95 (95% CI, 0.93-0.98).
CONCLUSIONS AND RELEVANCE
In this diagnostic study, NT-proBNP and IL-1 RL1 DBS assays identified high-risk CHD in a timely manner, including in asymptomatic newborns, and improved overall screening performance in this cohort from Sweden. Prospective evaluation of this novel approach is warranted.
Topics: Humans; Infant, Newborn; Heart Defects, Congenital; Neonatal Screening; Dried Blood Spot Testing; Biomarkers; Female; Male; Sweden; Natriuretic Peptide, Brain; Peptide Fragments; Case-Control Studies; Interleukin-1 Receptor-Like 1 Protein
PubMed: 38913376
DOI: 10.1001/jamanetworkopen.2024.18097 -
Advanced Science (Weinheim,... Nov 2023Flexible and wearable biosensors are the next-generation healthcare devices that can efficiently monitor human health conditions in day-to-day life. Moreover, the rapid... (Review)
Review
Flexible and wearable biosensors are the next-generation healthcare devices that can efficiently monitor human health conditions in day-to-day life. Moreover, the rapid growth and technological advancements in wearable optoelectronics have promoted the development of flexible organic photoplethysmography (PPG) biosensor systems that can be implanted directly onto the human body without any additional interface for efficient bio-signal monitoring. As an example, the pulse oximeter utilizes PPG signals to monitor the oxygen saturation (SpO ) in the blood volume using two distinct wavelengths with organic light emitting diode (OLED) as light source and an organic photodiode (OPD) as light sensor. Utilizing the flexible and soft properties of organic semiconductors, pulse oximeter can be both flexible and conformal when fabricated on thin polymeric substrates. It can also provide highly efficient human-machine interface systems that can allow for long-time biological integration and flawless measurement of signal data. In this work, a clear and systematic overview of the latest progress and updates in flexible and wearable all-organic pulse oximetry sensors for SpO monitoring, including design and geometry, processing techniques and materials, encapsulation and various factors affecting the device performance, and limitations are provided. Finally, some of the research challenges and future opportunities in the field are mentioned.
Topics: Humans; Photoplethysmography; Oximetry; Biosensing Techniques; Oxygen; Wearable Electronic Devices
PubMed: 37740697
DOI: 10.1002/advs.202302752 -
The American Journal of Hospice &... Oct 2023Despite the lack of evidence to support the use of palliative oxygen to relieve dyspnea at the end of life, its prescription is widespread and often supported by local...
Despite the lack of evidence to support the use of palliative oxygen to relieve dyspnea at the end of life, its prescription is widespread and often supported by local and national practice guidelines. The objectives of this study were (1) to determine to what extent oxygen prescriptions meet the proposed prescription criteria in our institution, (2) to examine the indication of individual prescriptions in relation to the severity of dyspnea and (3) to review the utilization of opioids in patients receiving palliative oxygen. Retrospective chart review of cancer patients who were prescribed palliative oxygen between April 2015 and January 2020 through a respiratory home care program in Quebec City, Canada. According to provincial prescription guidelines, palliative oxygen was provided and reimbursed in case of severe hypoxemia (pulse oximetry saturation at rest < 88%) in cancer patients with an estimated prognosis of less than 3 months. 134 patients receiving palliative oxygen were included; 25 (19%) did not fulfill reimbursement criteria. Median survival was 44 days. At initiation of palliative oxygen, 48 patients (36%) had only mild or moderate dyspnea (Medical Research Council dyspnea score 1-3), 26 (19%) did not receive opioids, and 9 (7%) were prescribed palliative oxygen without being dyspneic or receiving opioids. Most prescriptions of palliative oxygen met the proposed prescription criteria in our institution. Half of those who received palliative oxygen were only mildly dyspneic and/or were not receiving opioids at the time of the prescription.
Topics: Humans; Oxygen; Analgesics, Opioid; Retrospective Studies; Palliative Care; Neoplasms; Dyspnea
PubMed: 36452992
DOI: 10.1177/10499091221144005 -
JMIR Formative Research Nov 2023Patients with chronic respiratory diseases and those in the postdischarge period following hospitalization because of COVID-19 are particularly vulnerable, and little is...
BACKGROUND
Patients with chronic respiratory diseases and those in the postdischarge period following hospitalization because of COVID-19 are particularly vulnerable, and little is known about the changes in their symptoms and physiological parameters. Continuous remote monitoring of physiological parameters and symptom changes offers the potential for timely intervention, improved patient outcomes, and reduced health care costs.
OBJECTIVE
This study investigated whether a real-time multimodal program using commercially available wearable technology, home-based Bluetooth-enabled spirometers, finger pulse oximeters, and smartphone apps is feasible and acceptable for patients with chronic respiratory diseases, as well as the value of low-burden, long-term passive data collection.
METHODS
In a 3-arm prospective observational cohort feasibility study, we recruited 60 patients from the Royal Free Hospital and University College Hospital. These patients had been diagnosed with interstitial lung disease, chronic obstructive pulmonary disease, or post-COVID-19 condition (n=20 per group) and were followed for 180 days. This study used a comprehensive remote monitoring system designed to provide real-time and relevant data for both patients and clinicians. Data were collected using REDCap (Research Electronic Data Capture; Vanderbilt University) periodic surveys, Remote Assessment of Disease and Relapses-base active app questionnaires, wearables, finger pulse oximeters, smartphone apps, and Bluetooth home-based spirometry. The feasibility of remote monitoring was measured through adherence to the protocol, engagement during the follow-up period, retention rate, acceptability, and data integrity.
RESULTS
Lowest-burden passive data collection methods, via wearables, demonstrated superior adherence, engagement, and retention compared with active data collection methods, with an average wearable use of 18.66 (SD 4.69) hours daily (77.8% of the day), 123.91 (SD 33.73) hours weekly (72.6% of the week), and 463.82 (SD 156.70) hours monthly (64.4% of the month). Highest-burden spirometry tasks and high-burden active app tasks had the lowest adherence, engagement, and retention, followed by low-burden questionnaires. Spirometry and active questionnaires had the lowest retention at 0.5 survival probability, indicating that they were the most burdensome. Adherence to and quality of home spirometry were analyzed; of the 7200 sessions requested, 4248 (59%) were performed. Of these, 90.3% (3836/4248) were of acceptable quality according to American Thoracic Society grading. Inclusion of protocol holidays improved retention measures. The technologies used were generally well received.
CONCLUSIONS
Our findings provide evidence supporting the feasibility and acceptability of remote monitoring for capturing both subjective and objective data from various sources for respiratory diseases. The high engagement level observed with passively collected data suggests the potential of wearables for long-term, user-friendly remote monitoring in respiratory disease management. The unique piloting of certain features such as protocol holidays, alert notifications for missing data, and flexible support from the study team provides a reference for future studies in this field.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
RR2-10.2196/28873.
PubMed: 37999935
DOI: 10.2196/51507 -
Biomedical Optics Express Nov 2023Noninvasive transabdominal fetal pulse oximetry can provide clinicians critical assessment of fetal health and potentially contribute to improved management of...
Noninvasive transabdominal fetal pulse oximetry can provide clinicians critical assessment of fetal health and potentially contribute to improved management of childbirth. Conventional pulse oximetry through continuous wave (CW) light has challenges measuring the signals from deep tissue and separating the weak fetal signal from the strong maternal signal. Here, we propose a new approach for transabdominal fetal pulse oximetry through interferometric near-infrared spectroscopy (iNIRS). This approach provides pathlengths of photons traversing the tissue, which facilitates the extraction of fetal signals by rejecting the very strong maternal signal from superficial layers. We use a multimode fiber combined with a mode-field converter at the detection arm to boost the signal of iNIRS. Together, we can detect signals from deep tissue (>∼1.6 cm in sheep abdomen and in human forearm) at merely 1.1 cm distance from the source. Using a pregnant sheep model, we experimentally measured and extracted the fetal heartbeat signals originating from deep tissue. This validated a key step towards transabdominal fetal pulse oximetry through iNIRS and set a foundation for further development of this method to measure the fetal oxygen saturation.
PubMed: 38021126
DOI: 10.1364/BOE.500898 -
JAMA Network Open Aug 2023Many pulse oximeters have been shown to overestimate oxygen saturation in persons of color, and this phenomenon has potential clinical implications. The relationship...
IMPORTANCE
Many pulse oximeters have been shown to overestimate oxygen saturation in persons of color, and this phenomenon has potential clinical implications. The relationship between overestimation of oxygen saturation with timing of COVID-19 medication delivery and clinical outcomes remains unknown.
OBJECTIVE
To investigate the association between overestimation of oxygen saturation by pulse oximetry and delay in administration of COVID-19 therapy, hospital length of stay, risk of hospital readmission, and in-hospital mortality.
DESIGN, SETTING, AND PARTICIPANTS
This cohort study included patients hospitalized for COVID-19 at 186 acute care facilities in the US with at least 1 functional arterial oxygen saturation (SaO2) measurement between March 2020 and October 2021. A subset of patients were admitted after July 1, 2020, without immediate need for COVID-19 therapy based on pulse oximeter saturation (SpO2 levels of 94% or higher without supplemental oxygen).
EXPOSURES
Self-reported race and ethnicity, difference between concurrent SaO2 and pulse oximeter saturation (SpO2) within 10 minutes, and initially unrecognized need for COVID-19 therapy (first SaO2 reading below 94% despite SpO2 levels of 94% or above).
MAIN OUTCOME AND MEASURES
The association of race and ethnicity with degree of pulse oximeter measurement error (SpO2 - SaO2) and odds of unrecognized need for COVID-19 therapy were determined using linear mixed-effects models. Associations of initially unrecognized need for treatment with time to receipt of therapy (remdesivir or dexamethasone), in-hospital mortality, 30-day hospital readmission, and length of stay were evaluated using mixed-effects models. All models accounted for demographics, clinical characteristics, and hospital site. Effect modification by race and ethnicity was evaluated using interaction terms.
RESULTS
Among 24 504 patients with concurrent SpO2 and SaO2 measurements (mean [SD] age, 63.9 [15.8] years; 10 263 female [41.9%]; 3922 Black [16.0%], 7895 Hispanic [32.2%], 2554 Asian, Native American or Alaskan Native, Hawaiian or Pacific Islander, or another race or ethnicity [10.4%], and 10 133 White [41.4%]), pulse oximetry overestimated SaO2 for Black (adjusted mean difference, 0.93 [95% CI, 0.74-1.12] percentage points), Hispanic (0.49 [95% CI, 0.34-0.63] percentage points), and other (0.53 [95% CI, 0.35-0.72] percentage points) patients compared with White patients. In a subset of 8635 patients with a concurrent SpO2 - SaO2 pair without immediate need for COVID-19 therapy, Black patients were significantly more likely to have pulse oximetry values that masked an indication for COVID-19 therapy compared with White patients (adjusted odds ratio [aOR], 1.65; 95% CI, 1.33-2.03). Patients with an unrecognized need for COVID-19 therapy were 10% less likely to receive COVID-19 therapy (adjusted hazard ratio, 0.90; 95% CI, 0.83-0.97) and higher odds of readmission (aOR, 2.41; 95% CI, 1.39-4.18) regardless of race (P for interaction = .45 and P = .14, respectively). There was no association of unrecognized need for COVID-19 therapy with in-hospital mortality (aOR, 0.84; 95% CI, 0.71-1.01) or length of stay (mean difference, -1.4 days; 95% CI, -3.1 to 0.2 days).
CONCLUSIONS AND RELEVANCE
In this cohort study, overestimation of oxygen saturation by pulse oximetry led to delayed delivery of COVID-19 therapy and higher probability of readmission regardless of race. Black patients were more likely to have unrecognized need for therapy with potential implications for population-level health disparities.
Topics: Humans; Female; Middle Aged; Oxygen Saturation; Cohort Studies; COVID-19; Oximetry; Ethnicity
PubMed: 37615985
DOI: 10.1001/jamanetworkopen.2023.30856 -
Translational Lung Cancer Research Mar 2024
PubMed: 38601455
DOI: 10.21037/tlcr-23-820