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1.
Annu Int Conf IEEE Eng Med Biol Soc ; 2022: 4303-4307, 2022 07.
Article in English | MEDLINE | ID: covidwho-2018749

ABSTRACT

Continuous clinical grade measurement of SpO2 in out-of-hospital settings remains a challenge despite the widespread use of photoplethysmography (PPG) based wearable devices for health and wellness applications. This article presents two SpO2 algorithms: PRR (pulse rate derived ratio-of-ratios) and GPDR (green-assisted peak detection ratio-of-ratios), that utilize unique pulse rate frequency estimations to isolate the pulsatile (AC) component of red and infrared PPG signals and derive SpO2 measurements. The performance of the proposed SpO2 algorithms are evaluated using an upper-arm wearable device derived green, red, and infrared PPG signals, recorded in both controlled laboratory settings involving healthy subjects (n=36) and an uncontrolled clinic application involving COVID-19 patients (n=52). GPDR exhibits the lowest root mean square error (RMSE) of 1.6±0.6% for a respiratory exercise test, 3.6 ±1.0% for a standard hypoxia test, and 2.2±1.3% for an uncontrolled clinic use-case. In contrast, PRR provides relatively higher error but with greater coverage overall. Mean error across all combined datasets were 0.2±2.8% and 0.3±2.4% for PRR and GPDR respectively. Both SpO2 algorithms achieve great performance of low error with high coverage on both uncontrolled clinic and controlled laboratory conditions.


Subject(s)
COVID-19 , Wearable Electronic Devices , COVID-19/diagnosis , Heart Rate , Humans , Oximetry , Oxygen Saturation
2.
Bol. malariol. salud ambient ; 62(3): 428-435, 2022. tab, graf
Article in Spanish | WHO COVID, LILACS (Americas) | ID: covidwho-1995047

ABSTRACT

El COVID-19 es la causa más frecuente de SDRA generando cuadros clínicos leves, moderados y graves, en esta última, los pacientes podrían evolucionar a la necesidad de intubación orotraqueal y soporte ventilatorio avanzado; reportándose mortalidad de 26-90%, en estos casos. Es por ello, la necesidad de identificar factores de riesgos y herramientas predictores de mortalidad. En este estudio se determinó la validez diagnóstica de los índices de saturación de oxígeno y oxigenación como predictores de pronóstico de mortalidad en pacientes con SDRA severo por COVID-19 que requirieron de ventilación mecánica invasiva. Material y métodos: estudio transversal, analítico y retrospectivo. La muestra estuvo constituida por 176 historias clínicas de pacientes críticos. Se realizó análisis bivariado, y multivariado, además de determinar especificidad, sensibilidad, VPP, VPN y AUC. Resultados: 57,37% (101/176) de los pacientes fallecieron, con predominio del sexo masculino 79% (80/101); con edad promedio de 56 años. El lactato (p=0,115), no mostró asociación estadísticamente significativa. Contrariamente, en el análisis multivariado, el sexo masculino (p=0.04), glicemia (p=0,02) y, OI (p=0.00), arrojaron asociación. En cuanto a los índices, OSI registró sensibilidad y especificidad de 33% y 96% respectivamente; mientras que, IO tuvo 33,6% de sensibilidad y, 97,33% de especificidad; AUC 0,773 (IC: 0,677-0,868); es decir más del 77,3% de probabilidad de pronóstico a mortalidad. Conclusión: OSI y OI son adecuados predictores de mortalidad, teniendo OI mejor validez diagnóstico. Además, se ratifica, al sexo masculino y, aumento de valores glicémicos, como factores asociados a riesgo de desarrollar cuadros graves por COVID-19(AU)


COVID-19 is the most frequent cause of ARDS, generating mild, moderate and severe clinical symptoms, in the latter, patients could evolve to the need for orotracheal intubation and advanced ventilatory support; reporting mortality of 26-90% in these cases. This is why there is a need to identify risk factors and predictive tools for mortality. In this study, the diagnostic validity of the oxygen saturation and oxygenation indices as predictors of mortality prognosis in patients with severe ARDS due to COVID-19 who required invasive mechanical ventilation was determined. Material and methods: cross-sectional, analytical and retrospective study. The sample consisted of 176 medical records of critically ill patients. Bivariate and multivariate analyzes were performed, in addition to determining specificity, sensitivity, PPV, NPV, and AUC. Results: 57.37% (101/176) of the patients died, with a predominance of males 79% (80/101); with an average age of 56 years. Lactate (p=0.115) did not show a statistically significant association. Results: 57.37% (101/176) of the patients died, with a predominance of males 79% (80/101); with an average age of 56 years. Lactate (p=0.115) did not show a statistically significant association. Regarding the indices, OSI registered sensitivity and specificity of 33% and 96%, respectively; while IO had 33.6% sensitivity and 97.33% specificity; AUC 0.773 (CI: 0.677-0.868); that is, more than 77.3% probability of prognosis for mortality. Conclusion: OSI and OI are adequate predictors of mortality, with OI having better diagnostic validity. In addition, the male sex and increased glycemic values are confirmed as factors associated with the risk of developing serious conditions due to COVID-19(AU)


Subject(s)
Humans , Male , Female , Adolescent , Adult , Middle Aged , Aged , Prognosis , Respiratory Distress Syndrome, Newborn , Critical Illness , COVID-19/complications , Oxygen Saturation , Patients , Respiration, Artificial , Oxygenation , Cross-Sectional Studies , Risk Factors , Intubation
3.
BMC Med ; 20(1): 267, 2022 08 16.
Article in English | MEDLINE | ID: covidwho-1993362

ABSTRACT

BACKGROUND: During the COVID-19 pandemic, there have been concerns regarding potential bias in pulse oximetry measurements for people with high levels of skin pigmentation. We systematically reviewed the effects of skin pigmentation on the accuracy of oxygen saturation measurement by pulse oximetry (SpO2) compared with the gold standard SaO2 measured by CO-oximetry. METHODS: We searched Ovid MEDLINE, Ovid Embase, EBSCO CINAHL, ClinicalTrials.gov, and WHO International Clinical Trials Registry Platform (up to December 2021) for studies with SpO2-SaO2 comparisons and measuring the impact of skin pigmentation or ethnicity on pulse oximetry accuracy. We performed meta-analyses for mean bias (the primary outcome in this review) and its standard deviations (SDs) across studies included for each subgroup of skin pigmentation and ethnicity and used these pooled mean biases and SDs to calculate accuracy root-mean-square (Arms) and 95% limits of agreement. The review was registered with the Open Science Framework ( https://osf.io/gm7ty ). RESULTS: We included 32 studies (6505 participants): 15 measured skin pigmentation and 22 referred to ethnicity. Compared with standard SaO2 measurement, pulse oximetry probably overestimates oxygen saturation in people with the high level of skin pigmentation (pooled mean bias 1.11%; 95% confidence interval 0.29 to 1.93%) and people described as Black/African American (1.52%; 0.95 to 2.09%) (moderate- and low-certainty evidence). The bias of pulse oximetry measurements for people with other levels of skin pigmentation or those from other ethnic groups is either more uncertain or suggests no overestimation. Whilst the extent of mean bias is small or negligible for all subgroups evaluated, the associated imprecision is unacceptably large (pooled SDs > 1%). When the extent of measurement bias and precision is considered jointly, pulse oximetry measurements for all the subgroups appear acceptably accurate (with Arms < 4%). CONCLUSIONS: Pulse oximetry may overestimate oxygen saturation in people with high levels of skin pigmentation and people whose ethnicity is reported as Black/African American, compared with SaO2. The extent of overestimation may be small in hospital settings but unknown in community settings. REVIEW PROTOCOL REGISTRATION: https://osf.io/gm7ty.


Subject(s)
COVID-19 , Skin Pigmentation , Humans , Oximetry/methods , Oxygen , Oxygen Saturation , Pandemics
5.
Infect Dis (Lond) ; 54(9): 677-686, 2022 09.
Article in English | MEDLINE | ID: covidwho-1873825

ABSTRACT

BACKGROUND: Vital signs are critical in assessing the severity and prognosis of infections, for example, COVID-19, influenza, sepsis, and pneumonia. This study aimed to evaluate a new method for rapid camera-based non-contact measurement of heart rate, blood oxygen saturation, respiratory rate, and blood pressure. METHODS: Consecutive adult patients attending a hospital emergency department for suspected COVID-19 infection were invited to participate. Vital signs measured with a new camera-based method were compared to the corresponding standard reference methods. The camera device observed the patient's face for 30 s from ∼1 m. RESULTS: Between 1 April and 1 October 2020, 214 subjects were included in the trial, 131 female (61%) and 83 male (39%). The mean age was 44 years (range 18-81 years). The new camera-based device's vital signs measurements were, on average, very close to the gold standard but the random variation was larger than the reference methods. CONCLUSIONS: The principle of contactless measurement of blood pressure, pulse, respiratory rate, and oxygen saturation works, which is very promising. However, technical improvements to the equipment used in this study to reduce its random variability is required before clinical implementation. This will likely be a game changer once this is sorted out. CLINICAL TRIAL REGISTRATION: Universal Trial Number (UTN) U1111-1251-4114 and the ClinicalTrials.gov Identifier NCT04383457.


Subject(s)
COVID-19 , Adolescent , Adult , Aged , Aged, 80 and over , Blood Pressure , COVID-19/diagnosis , Female , Heart Rate , Humans , Male , Middle Aged , Oxygen Saturation , Respiratory Rate , Vital Signs , Young Adult
6.
PLoS One ; 17(5): e0268431, 2022.
Article in English | MEDLINE | ID: covidwho-1846939

ABSTRACT

BACKGROUND: The ratio of oxygen saturation (ROX) index, defined as the ratio of oxygen saturation (SpO2)/fraction of inspired oxygen (FiO2) to respiratory rate, can help identify patients with hypoxemic respiratory failure at high risk for intubation following high-flow nasal cannula (HFNC) initiation; however, whether it is effective for predicting intubation in coronavirus disease 2019 (COVID-19) patients receiving HFNC remains unknown. Moreover, the SpO2/FiO2 ratio has been assessed as a prognostic marker for acute hypoxemic respiratory failure. This study aimed to determine the utility of the ROX index and the SpO2/FiO2 ratio as predictors of failure in COVID-19 patients who received HFNC. METHODS: This multicenter study was conducted in seven university-affiliated hospitals in Korea. Data of consecutive hospitalized patients diagnosed with COVID-19 between February 10, 2020 and February 28, 2021 were retrospectively reviewed. We calculated the ROX index and the SpO2/FiO2 ratio at 1 h, 4 h, and 12 h after HFNC initiation. The primary outcome was HFNC failure defined as the need for subsequent intubation despite HFNC application. The receiver operating characteristic curve analysis was used to evaluate discrimination of prediction models for HFNC failure. RESULTS: Of 1,565 hospitalized COVID-19 patients, 133 who received HFNC were analyzed. Among them, 63 patients (47.4%) were successfully weaned from HFNC, and 70 (52.6%) were intubated. Among patients with HFNC failure, 32 (45.7%) died. The SpO2/FiO2 ratio at 1 h after HFNC initiation was an important predictor of HFNC failure (AUC 0.762 [0.679-0.846]). The AUCs of SpO2/FiO2 ratio at 4 h and ROX indices at 1 h and 4 h were 0.733 (0.640-0.826), 0.697 (0.597-0.798), and 0.682 (0.583-0.781), respectively. Multivariable analysis showed that the patients aged ≥70 years are 3.4 times more likely to experience HFNC failure than those aged <70 years (HR 3.367 [1.358-8.349], p = 0.009). The SpO2/FiO2 ratio (HR 0.983 [0.972-0.994], p = 0.003) at 1 h was significantly associated with HFNC failure. CONCLUSIONS: The SpO2/FiO2 ratio following HFNC initiation was an acceptable predictor of HFNC failure. The SpO2/FiO2 ratio may be a good prognostic marker for predicting intubation in COVID-9 patients receiving HFNC.


Subject(s)
COVID-19 , Noninvasive Ventilation , Respiratory Insufficiency , COVID-19/therapy , Cannula , Humans , Oxygen Inhalation Therapy , Oxygen Saturation , Respiratory Insufficiency/therapy , Retrospective Studies
7.
Am J Emerg Med ; 57: 54-59, 2022 07.
Article in English | MEDLINE | ID: covidwho-1803390

ABSTRACT

INTRODUCTION: Noninvasive risk assessment is crucial in patients with COVID-19 in emergency department. Since limited data is known about the role of noninvasive parameters, we aimed to evaluate the role of a noninvasive parameter 'SpO2/FiO2' in independently predicting 30-day mortality in patients with COVID-19 and its prognostic utility in combination with a noninvasive score 'CRB-65'. METHODS: A retrospective study was performed in a tertiary training and research hospital, which included 272 patients with COVID-19 pneumonia diagnosed with polymerase chain reaction in emergency department. Data on characteristics, vital signs, and laboratory parameters were recorded from electronic medical records. The primary outcome of the study was 30-day mortality, and we assessed the discriminative ability of SpO2/FiO2 in predicting mortality in patients with COVID-19 pneumonia and its prognostic utility in combination with conventional pneumonia risk assessment scores. RESULTS: Multivariate analysis revealed that only SpO2/FiO2 level was found to be an independent parameter associated with 30-day mortality (OR:0.98, 95% CI: 0.98-0.99, p = 0.003). PSI and CURB-65 were found to be better scores than CRB-65 in predicting 30-day mortality (AUC: 0.79 vs 0.72, p = 0.04; AUC: 0.76 vs 0.72, p = 0.01 respectively). Both SpO2/FiO2 combined with CRB-65 and SpO2/FiO2 combined with CURB-65 have good discriminative ability and seemed to be more favorable than PSI in predicting 30-days mortality (AUC: 0.83 vs 0.75; AUC: 0.84 vs 0.75), however no significant difference was found (p = 0.21 and p = 0.06, respectively). CONCLUSION: SpO2/FiO2 is a promising index in predicting mortality. Addition of SpO2/FiO2 to CRB-65 improved the role of CRB-65 alone, however it performed similar to PSI. The combined noninvasive model of SpO2/FiO2 and CRB-65 may help physicians quickly stratify COVID-19 patients on admission, which is expected to be particularly important in hospitals still stressed by pandemic volumes.


Subject(s)
COVID-19 , Pneumonia , COVID-19/diagnosis , Hospital Mortality , Humans , Oxygen Saturation , Pandemics , Pneumonia/diagnosis , Prognosis , Retrospective Studies , Severity of Illness Index
8.
Phytomedicine ; 95: 153868, 2022 Jan.
Article in English | MEDLINE | ID: covidwho-1720737

ABSTRACT

BACKGROUND: Huashibaidu Formula (HSBD) for the COVID-19 treatment has been supported by the China's Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia. However, it is not clear whether HSBD can improve blood oxygen saturation and when it should be used with conventional therapies. PURPOSE: To access the effect of HSBD combined with conventional treatment on blood oxygen saturation of COVID-19 patients. METHODS: A single-center retrospective cohort study was conducted to collect the confirmed severe COVID-19 patients' information, treated by the National Traditional Chinese Medicine Medical Team at the Jinyintan hospital between January 24 and March 31, 2020. According to whether HSBD was used during hospitalization, participants were separated into the conventional treatment group and the HSBD group (HSBD and conventional treatment). The primary observation indicators included the time for relieving blood oxygen saturation and the improvement ratio of blood oxygen saturation in each group. RESULTS: Of 111 patients with severe COVID-19, 53.2% (59/111) received HSBD, and 46.8% (52/111) only received conventional treatment, respectively. No statistically significant difference was found in image, clinical symptoms, and past medical history between the two groups (p > 0.05). Notably, the median time for relieving blood oxygen saturation in the conventional treatment group was 11 days (IQR, 8-14.25), while that in the HSBD group was only 6 days (IQR, 3.25-10.75), which was significantly shortened by 4.09 days (95%CI, 2.07-6.13; p= 0.0001), compared with the conventional treatment group. After repeated measurement design analysis, the main effect within times (p< 0.001) and the main effect were significantly different under the oxygen saturation dimension between two groups (p= 0.004). However, time and group interaction were observed no significant difference (p= 0.094). After 14 days of treatment, the improvement ratio of the HSBD group over the conventional treatment group was 1.20 (95%CI, 0.89-1.61). CONCLUSION: For severe COVID-19 patients, the HSBD has a tendency to shorten the time for relieving blood oxygen saturation. After taking a course of HSBD, the effect can be more obvious.


Subject(s)
COVID-19 , COVID-19/drug therapy , Humans , Oxygen Saturation , Retrospective Studies , SARS-CoV-2 , Treatment Outcome
11.
IEEE Rev Biomed Eng ; 15: 61-84, 2022.
Article in English | MEDLINE | ID: covidwho-1642571

ABSTRACT

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has caused a pandemic since early 2020. The coronavirus disease 2019 (COVID-19) has already caused more than three million deaths worldwide and affected people's physical and mental health. COVID-19 patients with mild symptoms are generally required to self-isolate and monitor for symptoms at least for 14 days in the case the disease turns towards severe complications. In this work, we overviewed the impact of COVID-19 on the patients' general health with a focus on their cardiovascular, respiratory and mental health, and investigated several existing patient monitoring systems. We addressed the limitations of these systems and proposed a wearable telehealth solution for monitoring a set of physiological parameters that are critical for COVID-19 patients such as body temperature, heart rate, heart rate variability, blood oxygen saturation, respiratory rate, blood pressure, and cough. This physiological information can be further combined to potentially estimate the lung function using artificial intelligence (AI) and sensor fusion techniques. The prototype, which includes the hardware and a smartphone app, showed promising results with performance comparable to or better than similar commercial devices, thus potentially making the proposed system an ideal wearable solution for long-term monitoring of COVID-19 patients and other chronic diseases.


Subject(s)
COVID-19 , Wearable Electronic Devices , Artificial Intelligence , Chronic Disease , Humans , Oxygen Saturation , SARS-CoV-2
12.
Am J Obstet Gynecol ; 226(6): 813-816, 2022 06.
Article in English | MEDLINE | ID: covidwho-1588395

ABSTRACT

Managing pregnant individuals with acute respiratory disease secondary to COVID-19 has been a challenge. Most professional societies including the Society for Maternal-Fetal Medicine recommend keeping O2 saturation at ≥95% in pregnant individuals. Reaching this target has been increasingly difficult in some patients, especially during the latest wave of infections attributed to the delta variant of SARS-CoV-2. In the absence of adequate supporting data, and in the setting of a reassuring fetal status, we propose that maternal O2 saturation should be maintained between 92% and 96% for admitted patients with acute respiratory failure who require supplemental O2. This may prevent unnecessary invasive interventions that might not hold maternal or fetal benefit, specifically at very preterm gestational ages.


Subject(s)
COVID-19 , Pregnancy Complications, Infectious , Respiratory Distress Syndrome , Female , Humans , Infant, Newborn , Oxygen Saturation , Pregnancy , Pregnancy Complications, Infectious/therapy , SARS-CoV-2
13.
Clinics (Sao Paulo) ; 76: e3368, 2021.
Article in English | MEDLINE | ID: covidwho-1579962

ABSTRACT

OBJECTIVES: Since there are difficulties in establishing effective treatments for COVID-19, a vital way to reduce mortality is an early intervention to prevent disease progression. This study aimed to evaluate the performance of patients with COVID-19 with acute hypoxic respiratory failure according to pulmonary impairment in the awake-prone position, outside of the intensive care unit (ICU). METHODS: A prospective observational cohort study was conducted on COVID-19 patients under noninvasive respiratory support. Clinical and laboratory data were obtained for each patient before the treatment and after they were placed in the awake-prone position. To identify responders and non-responders after the first prone maneuver, receiver operating characteristic curves with sensitivity and specificity of the PaO2/FiO2 and SpO2/FiO2 indices were analyzed. The maneuver was considered positive if the patient did not require endotracheal intubation for ventilatory assistance. RESULTS: Forty-eight patients were included, and 64.6% were categorized as responders. The SpO2/FiO2 index was effective for predicting endotracheal intubation in COVID-19 patients regardless of lung parenchymal damage (area under the curve 0.84, cutoff point 165, sensitivity 85%, specificity 75%). Responders had better outcomes with lower hospital mortality (hazard ratio [HR]=0.107, 95% confidence interval [CI]: 0.012-0.93) and a shorter length of stay (median difference 6 days, HR=0.30, 95% CI: 0.13-0.66) after adjusting for age, body mass index, sex, and comorbidities. CONCLUSIONS: The awake-prone position for COVID-19 patients outside the ICU can improve oxygenation and clinical outcomes regardless of the extent of pulmonary impairment. Furthermore, the SpO2/FiO2 index discriminates responders from non-responders to the prone maneuver predicting endotracheal intubation with a cutoff under or below 165.


Subject(s)
COVID-19 , Respiratory Distress Syndrome , Respiratory Insufficiency , Humans , Intensive Care Units , Oxygen Saturation , Prone Position , Prospective Studies , Respiratory Insufficiency/etiology , Respiratory Insufficiency/therapy , SARS-CoV-2 , Wakefulness
14.
Am J Emerg Med ; 50: 106-110, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1474264

ABSTRACT

BACKGROUND: This study aimed to evaluate the accuracy of pulse oximetry-derived oxygen saturation (SpO2) on room air, determined at hospital admission, as a predictor for the need for mechanical ventilatory support in patients with Coronavirus Disease-2019 (COVID-19). METHODS: In this retrospective observational study, demographic and clinical details of the patients were obtained during ICU admission. SpO2 and respiratory rate (RR) on room air were determined within the first 6 h of hospital admission. As all measurements were obtained on room air, we calculated the simplified respiratory rate­oxygenation (ROX) index by dividing the SpO2 by the RR. Based on the use of any assistance of mechanical ventilator (invasive or noninvasive), patients were divided into mechanical ventilation (MV) group and oxygen therapy group. The accuracy of the SpO2, CT score, and ROX index to predict the need to MV were determined using the Area under receiver operating curve (AUC). RESULTS: We included 72 critically ill patients who tested COVID-19-positive. SpO2 on the room air could predict any MV requirement (AUC [95% confidence interval]: 0.9 [0.8-0.96], sensitivity: 70%, specificity 100%, cut-off value ≤78%, P < 0.001). Within the MV group, the use of noninvasive ventilation (NIV) was successful in 37 (74%) patients, whereas 13 patients (26%) required endotracheal intubation. The cut-off ROX value for predicting early NIV failure was ≤1.4, with a sensitivity of 85%, a specificity of 86%, and an AUC of 0.86 (95% confidence interval of 0.73-0.94, P < 0.0001). CONCLUSIONS: A baseline SpO2 ≤78% is an excellent predictor of MV requirement with a positive predictive value of 100%. Moreover, the ROX index measured within the first 6 h of hospital admission is a good indicator of early NIV failure.


Subject(s)
COVID-19/metabolism , COVID-19/therapy , Critical Care , Oxygen Saturation , Respiration, Artificial , Respiratory Rate , Adult , Aged , Blood Gas Analysis , COVID-19/physiopathology , Diagnostic Tests, Routine , Female , Hospitalization , Humans , Male , Middle Aged , Oxygen Inhalation Therapy , Predictive Value of Tests , Retrospective Studies , Treatment Outcome
15.
Lancet Respir Med ; 9(12): 1365-1376, 2021 12.
Article in English | MEDLINE | ID: covidwho-1472211

ABSTRACT

BACKGROUND: Functional impairment of interferon, a natural antiviral component of the immune system, is associated with the pathogenesis and severity of COVID-19. We aimed to compare the efficacy of interferon beta-1a in combination with remdesivir compared with remdesivir alone in hospitalised patients with COVID-19. METHODS: We did a double-blind, randomised, placebo-controlled trial at 63 hospitals across five countries (Japan, Mexico, Singapore, South Korea, and the USA). Eligible patients were hospitalised adults (aged ≥18 years) with SARS-CoV-2 infection, as confirmed by a positive RT-PCR test, and who met one of the following criteria suggestive of lower respiratory tract infection: the presence of radiographic infiltrates on imaging, a peripheral oxygen saturation on room air of 94% or less, or requiring supplemental oxygen. Patients were excluded if they had either an alanine aminotransferase or an aspartate aminotransferase concentration more than five times the upper limit of normal; had impaired renal function; were allergic to the study product; were pregnant or breast feeding; were already on mechanical ventilation; or were anticipating discharge from the hospital or transfer to another hospital within 72 h of enrolment. Patients were randomly assigned (1:1) to receive intravenous remdesivir as a 200 mg loading dose on day 1 followed by a 100 mg maintenance dose administered daily for up to 9 days and up to four doses of either 44 µg interferon beta-1a (interferon beta-1a group plus remdesivir group) or placebo (placebo plus remdesivir group) administered subcutaneously every other day. Randomisation was stratified by study site and disease severity at enrolment. Patients, investigators, and site staff were masked to interferon beta-1a and placebo treatment; remdesivir treatment was given to all patients without masking. The primary outcome was time to recovery, defined as the first day that a patient attained a category 1, 2, or 3 score on the eight-category ordinal scale within 28 days, assessed in the modified intention-to-treat population, defined as all randomised patients who were classified according to actual clinical severity. Safety was assessed in the as-treated population, defined as all patients who received at least one dose of the assigned treatment. This trial is registered with ClinicalTrials.gov, NCT04492475. FINDINGS: Between Aug 5, 2020, and Nov 11, 2020, 969 patients were enrolled and randomly assigned to the interferon beta-1a plus remdesivir group (n=487) or to the placebo plus remdesivir group (n=482). The mean duration of symptoms before enrolment was 8·7 days (SD 4·4) in the interferon beta-1a plus remdesivir group and 8·5 days (SD 4·3) days in the placebo plus remdesivir group. Patients in both groups had a time to recovery of 5 days (95% CI not estimable) (rate ratio of interferon beta-1a plus remdesivir group vs placebo plus remdesivir 0·99 [95% CI 0·87-1·13]; p=0·88). The Kaplan-Meier estimate of mortality at 28 days was 5% (95% CI 3-7%) in the interferon beta-1a plus remdesivir group and 3% (2-6%) in the placebo plus remdesivir group (hazard ratio 1·33 [95% CI 0·69-2·55]; p=0·39). Patients who did not require high-flow oxygen at baseline were more likely to have at least one related adverse event in the interferon beta-1a plus remdesivir group (33 [7%] of 442 patients) than in the placebo plus remdesivir group (15 [3%] of 435). In patients who required high-flow oxygen at baseline, 24 (69%) of 35 had an adverse event and 21 (60%) had a serious adverse event in the interferon beta-1a plus remdesivir group compared with 13 (39%) of 33 who had an adverse event and eight (24%) who had a serious adverse event in the placebo plus remdesivir group. INTERPRETATION: Interferon beta-1a plus remdesivir was not superior to remdesivir alone in hospitalised patients with COVID-19 pneumonia. Patients who required high-flow oxygen at baseline had worse outcomes after treatment with interferon beta-1a compared with those given placebo. FUNDING: The National Institute of Allergy and Infectious Diseases (USA).


Subject(s)
Adenosine Monophosphate/analogs & derivatives , Alanine/analogs & derivatives , Antiviral Agents/therapeutic use , COVID-19 , Interferon beta-1a/therapeutic use , Adenosine Monophosphate/therapeutic use , Adult , Aged , Alanine/therapeutic use , COVID-19/drug therapy , Double-Blind Method , Female , Humans , Japan , Male , Mexico , Middle Aged , Oxygen , Oxygen Saturation , Republic of Korea , SARS-CoV-2 , Singapore , Treatment Outcome , United States
16.
Int J Clin Pract ; 75(12): e14983, 2021 Dec.
Article in English | MEDLINE | ID: covidwho-1462809

ABSTRACT

INTRODUCTION: Guidelines recommend using a pulse oximeter rather than arterial blood gas (ABG) for COVID-19 patients. However, significant differences can be observed between oxygen saturation measured by pulse oximetry (SpO2 ) and arterial oxygen saturation (SaO2 ) in some clinical conditions. We aimed to assess the reliability of the pulse oximeter in patients with COVID-19. METHODS: We retrospectively reviewed ABG analyses and SpO2 levels measured simultaneously with ABG in patients hospitalised in COVID-19 wards. RESULTS: We categorised total 117 patients into two groups, in whom the difference between SpO2 and SaO2 was ≤4% (acceptable difference) and >4% (large difference). A large difference group exhibited higher neutrophil count, C-reactive protein, ferritin, fibrinogen, D-dimer and lower lymphocyte count. Multivariate analyses revealed that increased fibrinogen, increased ferritin and decreased lymphocyte count were independent risk factors for a large difference between SpO2 and SaO2 . The total study group demonstrated the negative bias of 4.02% with the limits of agreement of -9.22% to 1.17%. The bias became significantly higher in patients with higher ferritin, fibrinogen levels and lower lymphocyte count. CONCLUSION: Pulse oximeters may not be sufficient to assess actual oxygen saturation, especially in COVID-19 patients with high ferritin and fibrinogen levels and low lymphocyte count with low SpO2 measurements.


Subject(s)
COVID-19 , Humans , Oximetry , Oxygen Saturation , Reproducibility of Results , Retrospective Studies , SARS-CoV-2
18.
Semin Dial ; 35(1): 71-80, 2022 01.
Article in English | MEDLINE | ID: covidwho-1276770

ABSTRACT

INTRODUCTION: Maintenance hemodialysis (MHD) patients are highly threatened in the novel coronavirus disease 2019 (COVID-19) pandemic, but evidence of risk factors for mortality in this population is still lacking. METHODS: We followed outcomes of the overall MHD population of Wuhan, including 7154 MHD patients from 65 hemodialysis centers, from January 1 to May 4, 2020. Among them, 130 were diagnosed with COVID-19. The demographic and clinical data of them were collected and compared between survivors and nonsurvivors. RESULTS: Compared to the corresponding period of last year, the all-cause mortality rate of the Wuhan MHD population significantly rose in February, and dropped down in March 2020. Of the 130 COVID-19 cases, 51 (39.2%) were deceased. Advanced age, decreased oxygen saturation, low diastolic blood pressure (DBP) on admission, and complications including acute cardiac injury (HR 5.03 [95% CI 2.21-11.14], p < 0.001), cerebrovascular event (HR 2.80 [95% CI 1.14-6.86], p = 0.025) and acute respiratory distress syndrome (HR 3.50 [95% CI 1.63-7.51], p = 0.001) were identified as independent risk factors for the death of COVID-19. The median virus shedding period of survivors was 25 days, longer than the general population. CONCLUSIONS: Maintenance hemodialysis patients are a highly vulnerable population at increased risk of mortality and prolonged virus shedding period in the ongoing COVID-19 pandemic. Advanced age, decreased oxygen saturation, low DBP on admission, and complications like acute cardiac injury are parameters independently associated with poor prognosis.


Subject(s)
COVID-19 , Humans , Oxygen Saturation , Pandemics , Renal Dialysis/adverse effects , Retrospective Studies , Risk Factors , SARS-CoV-2
19.
Arch Gynecol Obstet ; 305(2): 343-348, 2022 02.
Article in English | MEDLINE | ID: covidwho-1274829

ABSTRACT

PURPOSE: This study aimed to compare the effects of using single and double surgical masks (SM) on maternal oxygen saturation in pregnant women. METHODS: In this prospective study, single or double SM were worn by term pregnant women who applied for routine controls. The vital signs of the participants such as oxygen saturation, pulse, respiratory rate, fever, systolic and diastolic blood pressure were measured at admission and 30 min later. RESULTS: There were 223 participants in the single SM group and 231 participants in the double SM group. Thirty minutes after putting on the mask, there was no significant difference in the proportion of patients whose oxygen saturation fell below 95 (3.6 vs 5.6%, p = 0.301). No significant difference was observed between the admission and 30 min oxygen saturation levels of the pregnant women in the single SM group. However, maternal oxygen saturation after 30 min of the pregnant women in the double SM group was significantly lower (97.4 ± 1.1 vs 96.6 ± 1.3, p < 0.001). No significant changes were observed in the vital signs of either groups. CONCLUSION: When using double SM, oxygen saturation is significantly reduced compared to pre-mask values. Nevertheless, it seems difficult to say that these decreases have clinical significance.


Subject(s)
COVID-19 , Masks , Female , Humans , Oxygen , Oxygen Saturation , Pandemics , Pregnancy , Pregnant Women , Prospective Studies , SARS-CoV-2
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