Vital Sign Parameters Research Articles

Signatures of illness in children requiring unplanned intubation in the pediatric intensive care unit: A retrospective cohort machine-learning study.

Acute respiratory failure requiring the initiation of invasive mechanical ventilation remains commonplace in the pediatric intensive care unit (PICU). Early recognition of patients at risk for respiratory failure may provide clinicians with the opportunity to intervene and potentially improve outcomes. Through the development of a random forest model to identify patients at risk for requiring unplanned intubation, we tested the hypothesis that subtle signatures of illness are present in physiological and biochemical time series of PICU patients in the early stages of respiratory decompensation. We included 116 unplanned intubation events as recorded in the National Emergency Airway Registry for Children in 92 PICU admissions over a 29-month period at our institution. We observed that children have a physiologic signature of illness preceding unplanned intubation in the PICU. Generally, it comprises younger age, and abnormalities in electrolyte, hematologic and vital sign parameters. Additionally, given the heterogeneity of the PICU patient population, we found differences in the presentation among the major patient groups - medical, cardiac surgical, and non-cardiac surgical. At four hours prior to the event, our random forest model demonstrated an area under the receiver operating characteristic curve of 0.766 (0.738 for medical, 0.755 for cardiac surgical, and 0.797 for non-cardiac surgical patients). The multivariable statistical models that captured the physiological and biochemical dynamics leading up to the event of urgent unplanned intubation in a PICU can be repurposed for bedside risk prediction.

Radar-based remote physiological sensing: Progress, challenges, and opportunities.

Modern microwave Doppler radar-based physiological sensing is playing an important role in healthcare applications and during the last decade, there has been a significant advancement in this non-contact respiration sensing technology. The advantages of contactless, unobtrusive respiration monitoring have drawn interest in various medical applications such as sleep apnea, sudden infant death syndromes (SIDS), remote respiratory monitoring of burn victims, and COVID patients. This paper provides a perspective on recent advances in biomedical and healthcare applications of Doppler radar that can detect the tiny movement of the chest surfaces to extract heartbeat and respiration and its associated different vital signs parameters (tidal volume, heart rate variability (HRV), and so on) of the human subject. Additionally, it also highlights the challenges, and opportunities of this remote physiological sensing technology and several future research directions will be laid out to deploy this sensor technology in our day-to-day life.

Heartbeat and Body Temperature Monitoring System Based on Artificial Neural Networks

Heartbeat and body temperature are vital sign parameters for paramedics in strengthening the diagnosis of a disease. Medical staff generally use an electrocardiogram and thermometer to check the heart rate and body temperature. These tools are still manual and require concentration to get accurate values. This examination system is less useful because it requires a long time to collect data, increasing the burden on medical personnel and rising operational costs. To improve health services optimally, the authors propose the manufacture of heart rate and body temperature monitoring devices for the elderly based on wireless using the Artificial Neural Network (ANN) method. The proposed method can assist medical personnel in diagnosing heart attacks with three conditions (normal, low risk, and high risk). This study aims to assist medical staff in monitoring patients 'health conditions and diagnosing patients' heart disease in real time. This system uses PPG HRM-2511E sensor to detect heart rate and a DS18B20 sensor to detect body temperature. The data detection process uses a raspberry pi, and the decision-making system uses the ANN method. The results of testing the success rate of detecting the heartbeat of 97.90%, and the body temperature of 99.51%. The heart rate and body temperature data processing using ANN went as expected.

Emergency Medical Services Clinicians’ Perspectives on Pediatric Non-Transport

Objectives Emergency medical services clinicians do not transport one-third of all children assessed, even without official pediatric non-transport protocols. Little is known about how EMS clinicians and caregivers decide not to transport a child. Our objectives were to describe how EMS clinicians currently decide whether or not to transport a child and identify barriers to and enablers of successfully implementing an EMS clinician-initiated pediatric non-transport protocol. Methods We conducted six virtual focus groups with EMS clinicians from the mid-Atlantic. A PhD trained facilitator moderated all groups using a semi-structured moderator guide. Multiple investigators independently coded a deidentified sample transcript. One team member then completed axial coding of the remaining transcripts. Thematic saturation was achieved. Clusters of similar codes were grouped into themes by consensus. Results We recruited 50 participants, of whom 70% were paramedics and 28% emergency medical technicians. There was agreement that caregivers often use 9-1-1 for low acuity complaints. Participants stated that non-transport usually occurs after shared decision-making between EMS clinicians and caregivers; EMS clinicians advise whether transport is necessary, but caregivers are responsible for making the final decision and signing refusal documentation. Subthemes for how non-transport decisions were made included the presence of agency protocols, caregiver preferences, absence of a guardian on the scene, EMS clinician variability, and distance to the nearest ED. Participants identified the following features that would enable successful implementation of an EMS clinician-initiated non-transport process: a user-friendly interface, clear protocol endpoints, the inclusion of vital sign parameters, resources to leave with caregivers, and optional direct medical oversight. Conclusions EMS clinicians in our study agreed that non-transport is currently a caregiver decision, but noted a collaborative process of shared decision-making where EMS clinicians advise caregivers whether transport is indicated. Further research is needed to understand the safety of this practice. This study suggests there may be a need for EMS-initiated alternative disposition/non-transport protocols.

Research status and progress of intelligent wearable system for first aid based on body area network

<p>With the rise of electronic health services, wireless body area network (WBAN) technology has attracted great international attention. The body area network can obtain human vital sign parameters in its natural state, and support applications in areas such as clinical diagnosis and treatment, emergency rescue and treatment, and health information services. This article introduces the concept of body area network and the electronic medical architecture of body area network, summarizes the advantages of body area network: in low data rate scenarios, the system power consumption of body area network is much lower than that of other wireless communication standards, providing more choices for special frequency bands for medical equipment (500 MHz to 5 GHZ), thereby reducing the interference problem between different communications; proposing bottlenecks and hot spots of body area network: ultra-low power consumption requirements of sensor nodes and hardware resource constraints with limited computing power, and data security protection problems in body area network sensor nodes; the application of body area network in emergency scenarios was analyzed, and the hot spots of body area network research in the field of emergency were summarized and predicted: the development of ultra-low-power chips, wearable wireless nodes, intelligent medical terminals, health and monitoring instruments and other devices and equipment.</p>

Measurement of Vital Signs Respiratory Rate Based on Non Contact Techniques Using Thermal Camera & Web Camera with Facial Recognition

Examination of the respiratory rate is included in the calculation of vital sign parameters used by the medical team to determine whether a person's condition is good or not. Researchers want to develop a method of checking the respiratory rate that is easy to use by the general public and can display fast and precise results. During this pandemic, we are forced to reduce direct human-to-human contact with the aim of suppressing the exchange of viruses. From this condition, the researcher wants to develop a measuring instrument to measure the respiratory frequency with the non-contact method. This method is expected to reduce direct contact between humans and still get the results of the respiratory rate value which can be used as a parameter to determine a person's condition. To get the value of the respiratory rate, researchers have an idea by monitoring changes in temperature using a thermal camera. For the respiratory rate parameter, the researcher observed the nose area by detecting changes in expiratory and inspiration temperatures and then calculating the respiratory rate. To get these results, the researcher uses a method of detecting the face area or called face recognition and then detecting the ROI point in the area of interest in the nose area. In observing the respiratory rate, the temperature value during expiration is 31.05 °C while at the time of inspiration is 30.01 °C. This temperature difference will be carried out in the process of calculating the respiration rate value by the system made by the researcher. In the results of this study, it was found that the respiration rate module can be used as a reference with a normal use range of 60-120 cm with an error value of 1% if the distance is above 100 cm, then the results of this study are that this research can be implemented on a breathing frequency measuring instrument with a non-standard method. - contact

The Effect of Medical Mask Usage during Physical Activities on Vital Signs, Muscular Endurance, and Physical Fitness Index

The COVID-19 pandemic requires everyone to wear a mask as a preventive measure, including performing physical activities. This study aimed to determine the effect of medical mask use when performing physical exercises on oxygen saturation, vital signs, muscle endurance, and physical fitness index. The experimental analytical quantitative approach, with pre-test and post-test design, was used. Vital signs and oxygen saturation were measured briefly after brisk walking. The Push-up Test was conducted to measure muscle endurance, while the Harvard Step-up Test was used to measure Physical Fitness Index. The procedures were repeated twice, using medical masks and not using medical masks. The research subjects were 28 males aged 17-21 years with normal BMI. The results showed significant differences in the value of systolic blood pressure, pulse, respiratory rate, body temperature, oxygen saturation, muscle endurance, and physical fitness between the exercise using medical masks and not using medical masks. The p-values were 0.000 on all of these variables. A significant difference was also found in diastolic blood pressure with a p-value of 0.001. This study concludes that using medical masks during physical activity increases all vital sign parameters and decreases oxygen saturation, muscle endurance, and physical fitness levels.

Remote Monitoring of Patients With Hematologic Malignancies at High Risk of Febrile Neutropenia: Exploratory Study.

BackgroundFebrile neutropenia is one of the most common oncologic emergencies and is associated with significant, preventable morbidity and mortality. Most patients who experience a febrile neutropenia episode are hospitalized, resulting in significant economic cost.ObjectiveThis exploratory study implemented a remote monitoring system comprising a digital infrared thermometer and a pulse oximeter with the capability to notify providers in real time of abnormalities in vital signs that could suggest early clinical deterioration and thereby improve clinical outcomes.MethodsThe remote monitoring system was implemented and compared to standard-of-care vital signs monitoring in hospitalized patients with underlying hematologic malignancies complicated by a febrile neutropenia episode in order to assess the feasibility and validity of the system. Statistical analysis was performed using the intraclass correlation coefficient (ICC) to assess the consistency between the measurements taken using traditional methods and those taken with the remote monitoring system for each of the vital sign parameters (temperature, heart rate, and oxygen saturation). A linear mixed-effects model with a random subject effect was used to estimate the variance components. Bland-Altman plots were created for the parameters to further delineate the direction of any occurring bias.ResultsA total of 23 patients were enrolled in the study (mean age 56, SD 23-75 years; male patients: n=11, 47.8%). ICC analysis confirmed the high repeatability and accuracy of the heart rate assessment (ICC=0.856), acting as a supplement to remote temperature assessment. While the sensitivity and specificity for capturing tachycardia above a rate of 100 bpm were excellent (88% and 97%, respectively), the sensitivity of the remote monitoring system in capturing temperatures >37.8 °C and oxygen saturation <92% was 45% and 50%, respectively.ConclusionsOverall, this novel approach using temperature, heart rate, and oxygen saturation assessments successfully provided real-time, clinically valuable feedback to providers. While temperature and oxygen saturation assessments lagged in terms of sensitivity compared to a standard in-hospital system, the heart rate assessment provided highly accurate complementary data. As a whole, the system provided additional information that can be applied to a clinically vulnerable population. By transitioning its application to high-risk patients in the outpatient setting, this system can help prevent additional use of health care services through early provider intervention and potentially improve outcomes.

High-flow nasal cannula versus noninvasive ventilation in the prevention of escalation to invasive mechanical ventilation in patients with acute hypoxemic respiratory failure

Background High-flow nasal cannula (HFNC) is a device for conveying oxygen therapy. Emerging clinical evidence supports that it may be a compatible alternative for noninvasive ventilation (NIV) in patients with acute hypoxemic respiratory failure (ARF). Objective To compare the outcome of NIV versus HFNC oxygen therapy in preventing escalation to invasive mechanical ventilation in patients with ARF. Patients and methods A randomized controlled trial was conducted. One hundred consecutive patients who had ARF were allocated randomly to HFNC and NIV groups. The patients’ need for endotracheal intubation, dyspnea score, comfort scores, gasometric, in-hospital mortality, and vital sign parameters were the outcome measures. Patients’ baseline characteristics and the serial changes after HFNC or NIV therapy were measured. Results The HFNC group had 18% endotracheal intubation rate and 18% in-hospital mortality versus 50% and 48% for the NIV group (P=0.001). The median values of visual analog scale at 24, 48, 72, and 96 h were lower in the NIV group (P=0.000 for all). The median modified Borg scale at 24, 48, 72, and 96 h was lower in the HFNC group (P=0.00, 0.024, 0.040, and 0.001, respectively). The HFNC group had a significantly lower respiratory rate. Significant differences in baseline vital sign parameters between the NIV and HFNC groups were noticed after 1, 6, 24, and 48 h follow-up. Conclusion Delivering oxygen by HFNC is a new and efficient option for treating adults with ARF. HFNC showed a reduced rate of escalation to invasive mechanical ventilation and in-hospital mortality in comparison to NIV.

VitaFALL: Advanced Multi-Threshold Based Reliable Fall Detection System

Background: The biggest challenge in our technologically advanced society is the healthy being of aging individuals and differently-abled people in our society. The leading cause for significant injuries and early death in senior citizens and differently-abled people is due to falling off. The possibility to automatically detect falls has increased demand for such devices, and the high detection rate is achieved using the wearable sensors, this technology has a quite social and monetary impact on society. So even for the daily activity in the life of aged people, an automatically fall detecting system and vital signs examining system become a necessity. Objectives: This research work aims at helping aged people and every other necessary human by monitoring their vital signs and fall prediction. A fall detection VitaFALL (Vital Signs and Fall Monitoring) device, could analyze the measurement in all three orthogonal directions using a triple-axis accelerometer, and Vital Signs Parameters (Heartrate, Heartbeat, and Temperature monitoring) for the aged and differently-abled people. Methods: Comparison with Present Algorithms, there are various benefits regarding privacy, success rate, and design of devices upgraded using an implemented algorithm over the ubiquitous algorithm. Results: As concluded from the experimental outcomes, the accuracy achieved is up to 94%, ADXL335 is a 3-Axial Accelerometer Module that collects the accelerations of aged people from a VitaFALL device. A guardian can be notified by sending a text message via GSM and GPRS module so that aged can be helped. Conclusion: However, a delay in the time can be noticed while comparing the gradient and minimum value to predetermine the state of the older person. The experiment results show the adequacy of the proposed approach.

Bio-Radar Cardiac Signal Model Used for HRV Assessment and Evaluation Using Adaptive Filtering

The ability to remotely assess vital signs using radar systems may potentialize the healthcare systems, since it does not require any direct interaction with the subject. Nonetheless, these systems present inherent challenges that could compromise the accuracy of the vital signs parameters. For instance, there is a lack of resolution on the cardiac signal, since the radar only detects the chest micro displacement. Low cardiac resolution prevents the exact localization of signal peaks, compromising the Heart Rate Variability (HRV) assessment. In this work, we use a customized band-pass filter obtained through adaptive filtering, applied to the Electrocardiography (ECG) signal to generate the corresponding synthetic radar signal. This provides an easy way to extract a cardiac radar signal model, free of issues that arise from random body motion or from an eventual decrease in signals quality, which are inherent issues of long-term acquisitions. This model was further used to verify if the signal resolution provided by lower carrier radars is suitable to determine the HRV parameters accurately.

Predictor of Early Administration of Antibiotics and a Volume Resuscitation for Young Infants with Septic Shock.

(1) Background: It is critical to administer antibiotics and fluid bolus within 1 h of recognizing sepsis in pediatric patients. This study aimed to identify the predictor of the successful completion of a 1-h sepsis bundle for infants with suspected sepsis. (2) Methods: This is an observational study using a prospective registry including febrile young infants (aged < 90 days) who visited a pediatric emergency department with a core body temperature of 38.0 °C or higher and 36.0 °C or lower. Univariate and logistic regression analyses were conducted to determine the predictor (s) of successful sepsis bundle completion. (3) Results: Of the 323 registered patients, 118 patients with suspected sepsis were analyzed, and 38 patients (32.2%) received a bundle-compliant treatment. Among potential variables, such as age, sex, and vital sign parameters, the logistic regression analysis showed that heart rate (odds ratio: OR 1.02; 95% confidence interval: 1.00–1.04) is a significant predictor of the completion of a 1-h sepsis bundle. (4) Conclusions: We found that tachycardia facilitated the sepsis recognition and promoted the successful completion of a 1-h sepsis bundle for young infants with suspected septic shock and a possible indicator for improving the quality of the team-based sepsis management.

A Machine-Learning-Based System for Prediction of Cardiovascular and Chronic Respiratory Diseases.

Cardiovascular and chronic respiratory diseases are global threats to public health and cause approximately 19 million deaths worldwide annually. This high mortality rate can be reduced with the use of technological advancements in medical science that can facilitate continuous monitoring of physiological parameters—blood pressure, cholesterol levels, blood glucose, etc. The futuristic values of these critical physiological or vital sign parameters not only enable in-time assistance from medical experts and caregivers but also help patients manage their health status by receiving relevant regular alerts/advice from healthcare practitioners. In this study, we propose a machine-learning-based prediction and classification system to determine futuristic values of related vital signs for both cardiovascular and chronic respiratory diseases. Based on the prediction of futuristic values, the proposed system can classify patients' health status to alarm the caregivers and medical experts. In this machine-learning-based prediction and classification model, we have used a real vital sign dataset. To predict the next 1–3 minutes of vital sign values, several regression techniques (i.e., linear regression and polynomial regression of degrees 2, 3, and 4) have been tested. For caregivers, a 60-second prediction and to facilitate emergency medical assistance, a 3-minute prediction of vital signs is used. Based on the predicted vital signs values, the patient's overall health is assessed using three machine learning classifiers, i.e., Support Vector Machine (SVM), Naive Bayes, and Decision Tree. Our results show that the Decision Tree can correctly classify a patient's health status based on abnormal vital sign values and is helpful in timely medical care to the patients.

P112 Under-mattress sleep monitoring to predict readmission risk after COPD exacerbation

Abstract Background Recurrent hospitalisation for COPD exacerbations is a major contributor to disease burden and healthcare costs. This study aims to establish if post-discharge sleep or vital sign parameters are predictive of hospital readmissions after COPD exacerbations. Methods Patients admitted with a COPD exacerbation were recruited from November 2019 until May 2021. Sleep parameters were assessed for at least one night in hospital and 10 nights post-discharge using an under-mattress device (EarlySense). Analysis on data from the first 26 participants were conducted using independent sample Mann-Whitney U tests comparing device-estimated sleep parameters between participants admitted versus not readmitted at one- and three-months post-discharge. Progress to date Thirty-four participants have consented. In the 26 participants completing the study to date, all-cause hospital readmission rates at one- and three-months were 26% and 65% respectively. Participants readmitted versus not readmitted at one-month had lower percentage of time in light sleep (43 ± 12% vs 58 ± 12%, p=0.029) and lower estimated AHI (5.6 ± 1.9 vs 17 ± 11 /hr, p=0.042). There were no differences at three-months. Intended outcome and impact Data from the full cohort will be used to assess heart rate and respiratory rate across each night and stage of sleep which could reveal clinically useful methods in the emerging field of ambulatory sleep monitoring. The feasibility and challenges of using ambulatory monitoring devices in patients with chronic respiratory disease will be reported. This study will guide future work that could potentially improve ambulatory monitoring through user-friendly and clinically feasible devices.

An interrater reliability study on the Gothenburg obstetric triage system- a new obstetric triage system

BackgroundTriage, identifying patients with critical and time-sensitive disorders, is an integrated process in general emergency medicine. Obstetric triage is more specialised, requiring assessment of both woman, fetus and labour status. Failure to identify severely ill obstetric patients has repeatedly led to maternal morbidity and mortality. Reliable triage systems, adapted to obstetric patients as well as local conditions, are thus essential. The study aims to assess the interrater reliability (IRR) of the Gothenburg Obstetric Triage System (GOTS).MethodsMidwives (n = 6) and registered nurses with no experience in managing obstetric patients (n = 7), assessed 30 paper cases based on actual real-life cases, using the GOTS. Furthermore, a reference group consisting of two midwives and two obstetricians, with extensive experience in obstetric care, determined the correct triage level in order to enable analysis of over- and undertriage. IRR was assessed, both with percentage of absolute agreement and with intra-class correlation coefficients (ICC) with 95% confidence intervals (CI).ResultsA total of 388 assessments were performed, comprising all five levels of acuity in the GOTS. Absolute agreement was found in 69.6% of the assessments. The overall IRR was good, with a Kappa value of 0.78 (0.69–0.87, 95% CI) for final triage level. Comparison with reference group assessments established that over- and undertriage had occurred in 9% and 21% of the cases, respectively. The main reasons for undertriage were “not acknowledging abnormal vital sign parameters” and “limitations in study design”.ConclusionThe GOTS is a reliable tool for triaging obstetric patients. It enables a standardized triage process unrelated to the assessors’ level of experience in assessing and managing obstetric patients and is applicable for triaging obstetric patients presenting for emergency care at obstetric or emergency units.

Substance consumption and intoxication patterns in a medically supervised overdose prevention program for people experiencing homelessness

Background: Opioid overdose is a leading cause of death among homeless individuals. Combining psychoactive substances with opioids increases overdose risk. This study aimed to describe intoxication patterns at a drop-in space offering medical monitoring and harm reduction services to individuals who arrive intoxicated and at risk of overdose. Methods: We examined data from visits to the Supportive Place for Observation and Treatment at Boston Health Care for the Homeless Program between January 1, 2017 and December 31, 2017. We used k-means cluster analysis to characterize intoxication patterns based on clinically assessed sedation levels and vital sign parameters. Multinomial logistic regression analysis assessed demographic and substance consumption predictors of cluster membership. Linear and logistic regression models examined associations between cluster membership and care outcomes. Results: Across 305 care episodes involving 156 unique patients, cluster analysis revealed 3 distinct intoxication patterns. Cluster A (26.6%) had mild sedation and normal vital signs. Cluster B (44.5%) featured greater sedation with bradycardia and/or hypotension. Cluster C (28.9%) was comparable to cluster B but with the addition of hypoxia. Self-reported consumption of non-opioid sedatives prior to arrival was common (63.3% of episodes) and predicted membership in cluster B (aOR 2.75, 95% CI 1.40, 5.40) and cluster C (aOR 3.38, 95% CI 1.48, 7.70). In comparison to cluster A episodes, cluster C episodes were longer (mean 4.8 vs. 2.3 hours, p < 0.001) and more likely to require supplemental oxygen (27.3% vs. 2.5%, p < 0.001). Few episodes required hospital transfer (4.7%) or naloxone (1.0%). No deaths occurred. Conclusions: In a medically supervised overdose monitoring program, reported use of non-opioid sedatives strongly predicted more complex clinical courses and should be factored into overdose prevention efforts. Low-threshold medical monitoring in an ambulatory setting was sufficient for most episodes, suggesting a role for such programs in reducing harm and averting costly emergency services.

The effect of restorative dentistry practices on the vital signs of healthy individuals

Aim: Clinical applications of dentistry, the tools and drugs used increase the effects of anxiety and stress factors that we encounter before the treatment, but also cause changes in the life symptoms of the patients. In this study, it is aimed to evaluate the effects of Restorative Dentistry applications on vital signs parameters such as blood pressure, heart rate, body temperature and oxygen saturation of healthy individuals before and after the interventional procedure.&#x0D; Material and Method: In the study, blood pressure, pulse rate, body temperature and oxygen saturation values ​​of 100 patients without any systemic disease were measured before clinical applications. Following the treatment intervention, the same parameters were measured again and evaluated by comparing the previous and next values.&#x0D; Result: In the patients who were not applied local anesthesia, the post-treatment measurement values ​​of the body temperature parameter were significantly higher than the initial measurement values ​​(p0.05). In patients who were applied local anesthesia, the last measurement values ​​of body temperature and systolic blood pressure were significantly lower than the initial measurement values ​​(p0.05).&#x0D; Conclusion: We think that measures such as a relationship based on mutual trust, approaching expectations with understanding, informing about interventional procedures and operating consent processes will prevent patients from anxiety during the session and keep vital parameter values ​​at a normal level.

Abstract CT122: Safety and pharmacokinetics of BLU-263, a next-generation KIT inhibitor, in normal healthy volunteers

Abstract Background: BLU-263 is an investigational, potent, and selective oral small-molecule inhibitor of KIT with sub-nanomolar potency on D816V-mutant KIT. Systemic mastocytosis is driven by the KIT D816V mutation in approximately 95% of cases and is vulnerable to KIT D816V inhibition. BLU-263 was highly active in a murine model of mastocytosis and was well tolerated with minimal central nervous system penetration in preclinical species. Here, we report the safety, tolerability, and pharmacokinetics (PK) of BLU-263 in an ongoing phase I, randomized, double-blinded, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) trial. Methods: In the SAD portion of the trial, cohorts of eight normal healthy volunteers aged ≥19 years received either oral placebo (n=2/cohort) or single oral doses of BLU-263 (n=6/cohort) of 15, 25, 50, 100, or 200 mg. In the MAD portion of the trial, normal healthy volunteer cohorts received either oral placebo or BLU-263 at 25, 50, or 100 mg once daily (QD) on each of 10 consecutive days. Blood plasma samples were collected for PK analyses at pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 48, 72, and 96 h post-dose in SAD cohorts, and the same post-dose time points on Days 1 and 10 in the MAD cohorts. Safety was assessed according to incidence and severity of adverse events (AEs) in recipients of BLU-263 as compared with placebo. Results: BLU-263 was well-tolerated across the five BLU-263 SAD cohorts and three MAD cohorts. Only Grade 1 AEs were reported, and most were assessed as not related to the study drug by the investigator. These AEs included pain at blood-sampling site, headache, dry/itchy skin, nausea, and stomachache. No serious AEs were reported, and there were no clinically relevant findings in laboratory, electrocardiogram, or vital signs parameters. After administration of BLU-263 at single doses, the median time to maximum concentration ranged from 1.5 to 6 h post-dose. The mean half-life of BLU-263 ranged from 20 to 28 h, indicating that steady-state is expected to be reached by Day 7, and supports QD dosing. After 10 days of repeated oral administration of 25 to 100 mg BLU-263, the geometric mean accumulation ratio for area under the curve ranged from 1.6 to 1.8. The geometric mean apparent volume of distribution ranged from 753 to 973 L, indicating wide tissue distribution. Overall, a dose-proportional increase in systemic exposure to BLU-263 was observed across the SAD and MAD cohorts. Conclusions: BLU-263, a next-generation investigational KIT inhibitor, was well tolerated across all SAD and MAD cohorts in healthy volunteers. The PK of BLU-263 were linear across the dose ranges in SAD and MAD cohorts and support QD dosing. These data support continued development of BLU-263 in patients with systemic mastocytosis and other mast cell disorders. Citation Format: Nimita Dave, Marissa Devlin, Jill Rodstrom, Bei Yu, Megan Foley, Kevin He, Scott Rasmussen, Andy Boral, Tuan Dong Si. Safety and pharmacokinetics of BLU-263, a next-generation KIT inhibitor, in normal healthy volunteers [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT122.

The effect of familiarization with preoperative care on anxiety and vital signs in the patient's cesarean section: A randomized controlled trial.

INTRODUCTIONCesarean section (C-section) is one of the most prevalent surgeries among women. The preoperative stages in the surgery day and lack of control over being in an unfamiliar situation and feeling danger cause anxiety, and consequently, instability in patients. This study aimed to determine the effect of familiarization with preoperative nursing care on anxiety and vital signs of patients in cesarean section.METHODSThis randomized controlled trial study was performed on 80 pregnant candidates for C-section in Hamadan Fatemieh Hospital, Iran, in 2020. Patients were randomly divided into control (n=40) and intervention (n=40) groups. The control group just received the routine intervention of the hospital, but the intervention group, in addition, received the two familiarizing sessions with preoperative nursing care. Data were collected via vital signs sheet and Spielberger situational anxiety questionnaire and were analyzed using SPSS16 software at a significance level of p=0.05.RESULTSBefore the intervention, there was no significant difference between the mean anxiety scores of the control and intervention groups, and the two groups were homogeneous (p=0.396). However, after the intervention, the mean anxiety of the intervention group decreased significantly (p=0.001) and increased in the control group (p=0.600); and the mean post-test of the two groups showed a significant difference (p=0.001). After the intervention, the mean heart rate, respiration rate, systolic and diastolic blood pressure in the intervention group decreased significantly (p<0.05). However, there was no significant difference in heart rate and systolic blood pressure of the control group (p>0.05).CONCLUSIONSBased on the results of this study we conclude that familiarity with preoperative care reduces the level of anxiety and stabilized the level of vital signs parameters.

Extracorporeal Blood Purification in Moderate and Severe COVID-19 Patients: A Prospective Cohort Study

Introduction: Coronavirus disease 2019 (COVID-19) is characterized by hyperinflammation and coagulopathy. Severe cases often develop respiratory distress, requiring mechanical ventilation and with critical cases progressing to acute respiratory distress syndrome. Control of hyperinflammation has been proposed as a possible therapeutic avenue for COVID-19; extracorporeal blood purification (EBP) modalities offer an attractive mean to ameliorate maladaptive inflammation. With this work, we evaluated the longitudinal changes of systemic inflammatory markers in critically ill COVID-19 patients treated with blood purification using AN69ST (oXiris®) haemofilter. Methods: We performed a time-series analysis of 44 consecutive COVID-19 cases treated with the AN69ST (oXiris®) cytokine adsorbing haemofilter (CAH) according to local practice; we visualize longitudinal results of biochemical, inflammatory, blood gas, and vital sign parameters focussing on systemic levels of interleukin-6 (IL-6), C-reactive protein (CRP), and procalcitonin. Results: All patients were treated with ≥1 cycle extracorporeal continuous venovenous haemofiltration (CVVH) with CAH; of these, 30 severe patients received CVVH-CAH within 4–12 h of admission after recognizing a hyper-inflammatory state. Another 14 patients admitted with mild-to-moderate symptoms progressed to severe disease and were placed on EBP during hospitalization. The treatment was associated with a reduction of ferritin, CRP, fibrinogen, several inflammatory markers, and a resolution of numerous cytopenias. The observed mortality across the cohort was 36.3%. Conclusion: EBP with CAH was associated with a decrease in CRP, and control of IL-6 and procalcitonin.