Vital Sign Measurements Research Articles

Prospective clinical validation of a noncontact vital signs measurement smartphone application in emergency department

Abstract Background Remote photoplethysmography (rPPG) is a noncontact optical measurement technique that can be used to detect blood volume changes in the microvascular bed of tissue, using a RGB camera. We developed a smartphone application that leverages rPPG in order to monitor the heart rate and respiratory rate of patients using a 30s video selfie. Due to the widespread availability of cameras in smartphones, tablets and laptops, such an application allows to automate noncontact physiological monitoring and recording, improving the quality and accessibility of this essential clinical information. Purpose This study aimed to evaluate the accuracy of such remote measurements compared with regular contact based measurement methods (pulse oximeter) in real-life clinical settings. Methods We recruited 443 patients who consulted the emergency department in 4 French hospitals. After obtaining written informed consent, the patients filled in a questionnaire collecting demographic information including age, gender and the Fitzpatrick skin phototype. Each patient was asked to sit in front of the tablet, with the reference pulse oximeter installed on their finger. All measurements were 30s long. When starting the measurement, the medical staff started to count the patient's respiratory cycles. After 15s, the first COBOX result was available, and then updated every second. At the end of the 30s, the medical staff reported the number of respiratory cycles which were doubled to obtain a respiratory rate in cycles per minute (cpm). Results The mean age was 44 ± 18 years old, 45% was male. A total of 6311 pairs of values of heart rate taken by COBOX (HRCOBOX) and by the reference pulse oximeter (HRreference) and 453 pairs of values of respiratory rate taken by COBOX (RRCOBOX) and by the reference manual count (RRreference) were collected. The proportion of heart rates > 100bpm (beats per minute) was 4.4% and of respiratory rates > 20cpm was 22.9%. The number of insufficient quality measurements was 838 for heart rate (13%). The medical staff could not count reliably the respiratory rate in 20 sessions (4.4%). 30 sessions (6.9%) had a measurement of insufficient quality. For the heart rate, the Pearson correlation between COBOX and the reference was 97.2%. The root mean square error (RMSE) was 3.1bpm. For the respiratory rate, the Pearson correlation between COBOX and the reference was 78.3%. The RMSE was 2.9cpm. Conclusion Our work aimed to evaluate the accuracy of such remote measurements compared with existing contact point measurement methods in real-life clinical settings. Our results described a very good accuracy and correlation between the rPPG system and the gold standard, thus paving the way for more precise and more accessible remote patient monitoring. Such a technology has the potential to be transformative for telemedicine, especially in medical deserts where the access to both physicians and medical devices is lacking.Heart rate resultsRespiratory rate results

Machine Learning Models Versus the National Early Warning Score System for Predicting Deterioration: Retrospective Cohort Study in the United Arab Emirates

Background Early warning score systems are widely used for identifying patients who are at the highest risk of deterioration to assist clinical decision-making. This could facilitate early intervention and consequently improve patient outcomes; for example, the National Early Warning Score (NEWS) system, which is recommended by the Royal College of Physicians in the United Kingdom, uses predefined alerting thresholds to assign scores to patients based on their vital signs. However, there is limited evidence of the reliability of such scores across patient cohorts in the United Arab Emirates. Objective Our aim in this study was to propose a data-driven model that accurately predicts in-hospital deterioration in an inpatient cohort in the United Arab Emirates. Methods We conducted a retrospective cohort study using a real-world data set that consisted of 16,901 unique patients associated with 26,073 inpatient emergency encounters and 951,591 observation sets collected between April 2015 and August 2021 at a large multispecialty hospital in Abu Dhabi, United Arab Emirates. The observation sets included routine measurements of heart rate, respiratory rate, systolic blood pressure, level of consciousness, temperature, and oxygen saturation, as well as whether the patient was receiving supplementary oxygen. We divided the data set of 16,901 unique patients into training, validation, and test sets consisting of 11,830 (70%; 18,319/26,073, 70.26% emergency encounters), 3397 (20.1%; 5206/26,073, 19.97% emergency encounters), and 1674 (9.9%; 2548/26,073, 9.77% emergency encounters) patients, respectively. We defined an adverse event as the occurrence of admission to the intensive care unit, mortality, or both if the patient was admitted to the intensive care unit first. On the basis of 7 routine vital signs measurements, we assessed the performance of the NEWS system in detecting deterioration within 24 hours using the area under the receiver operating characteristic curve (AUROC). We also developed and evaluated several machine learning models, including logistic regression, a gradient-boosting model, and a feed-forward neural network. Results In a holdout test set of 2548 encounters with 95,755 observation sets, the NEWS system achieved an overall AUROC value of 0.682 (95% CI 0.673-0.690). In comparison, the best-performing machine learning models, which were the gradient-boosting model and the neural network, achieved AUROC values of 0.778 (95% CI 0.770-0.785) and 0.756 (95% CI 0.749-0.764), respectively. Our interpretability results highlight the importance of temperature and respiratory rate in predicting patient deterioration. Conclusions Although traditional early warning score systems are the dominant form of deterioration prediction models in clinical practice today, we strongly recommend the development and use of cohort-specific machine learning models as an alternative. This is especially important in external patient cohorts that were unseen during model development.

Case report of rare tissue injury and left arm dislocation after incorrect blood pressure measurement during clinical practice

In midwifery education based on theoretical and practical foundations, students encounter midwifery profession education which based on for the first time in the Basic Clinical Skills in Midwifery Course. The aim of the Basic Clinical Skills in Midwifery Course is to help students understand the basic philosophy of midwifery and the role of the midwife in the health system, and to provide the student with knowledge, skills and attitudes about the basic concepts, principles and methods in midwifery care. In the Basic Clinical Skills in Midwifery Course, students are offered learning methods that will enable them to develop behaviors in the cognitive, affective and psychomotor domains. In this context, the course is carried out in skill development laboratories and clinical environments, after the lecturer in the classroom explains the basic concepts, the health system and midwifery, the protection and development of health, the fulfillment of physiological care needs, and the demonstration of the skills related to the psychomotor domain. Clinical practices are an indispensable element of midwifery education. The Midwifery Basic Clinical Skills Course has a very important place in clinical skills training, as students experience the hospital environment for the first time in their education life and experience midwifery practices for the first time on real patients. The aim here is to discuss a case that can be experienced after the correct application of vital sign measurement techniques and erroneous measurement.

Optec: A Phase 2 Study to Evaluate Outpatient Administration of Teclistamab, a BCMA-Targeting Bispecific Antibody, in Patients with Multiple Myeloma

Background: Teclistamab is the only approved BCMA×CD3 bispecific antibody with a personalized, weight-based dosing schedule for the treatment of triple-class exposed relapsed/refractory multiple myeloma (RRMM). It is FDA approved for patients (pts) of therapy (LOTs), including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody. In the pivotal MajesTEC-1 study (Moreau et al NEJM 2022), teclistamab showed deep and durable responses and a manageable safety profile in heavily pretreated pts with RRMM who had limited treatment options. The incidence of all grade cytokine release syndrome (CRS) during the first 2 cycles was 70%. Most pts experienced CRS following step-up doses 1 (42%) or 2 (35%), or the initial treatment dose (24%); 33% of pts experienced recurrent CRS. Most CRS events were grade 1/2 and fully resolved without discontinuation or dose reduction of teclistamab. One (0.6%) case of grade 3 CRS occurred in a pt who pneumonia but resolved in 2 days. No grade 4 or 5 CRS occurred. Tocilizumab is a monoclonal antibody targeting the interleukin-6 receptor (IL-6R) which is used to manage CRS resulting from T-cell redirection therapy. Preclinical data indicate that inhibition of IL-6 signaling prior to teclistamab administration can prevent CRS development without impacting anti-tumor activity (Li et al Ann. Oncol. 2019). In MajesTEC-1, pts who received a single IV dose of tocilizumab before the first teclistamab step-up dose (n=23) showed a reduction in the incidence of all grades of CRS, compared with the overall study population (26% vs 72%). Currently, there are no data on the safety of administering the step-up doses of teclistamab in the outpatient (OP) setting, but OP step-up dosing may make teclistamab more accessible. Therefore, we seek to investigate whether the use of prophylactic tocilizumab can reduce the incidence and severity of CRS associated with teclistamab and allow safe OP administration of the step-up dosing. Methods: This single-arm, non-randomized, multicenter, prospective study (NCT05972135) will evaluate CRS incidence and severity after prophylactic tocilizumab in pts treated with teclistamab in the OP setting. A target of 50 participants will be enrolled with an initial PK/PD safety cohort (n=10). Objectives through end of study include recurrent CRS, grade ≥3 and any grade infections, neurotoxicity including ICANS, neutropenia, febrile neutropenia, and efficacy. Eligible pts are ≥18 years with a documented diagnosis of RRMM who have previously received ≥4 LOTs. Pts with rapidly progressing disease, central nervous system involvement, active infection, or contraindication to tocilizumab will be excluded from the trial. Prior to the treatment phase, pts will participate in a 28-day screening phase to determine study eligibility. During the treatment phase, a single dose of tocilizumab will be administered at 8 mg/kg IV, 2 to 4 hours prior to step-up dose 1 of teclistamab (Cycle 1 Day 1) in an outpatient setting (Figure 1). Teclistamab will then be administered at step-up doses of 0.06 mg/kg subcutaneously (SC) (Cycle 1 Day 1) and 0.3 mg/kg SC (Cycle 1 Days 3-5), followed by 1.5 mg/kg SC (Cycle 1 Day 8), with weekly administration for twelve 28-day cycles or until disease progression or unacceptable toxicity. Teclistamab may be reduced to 1.5 mg/kg SC every two weeks for participants who achieve partial response or better after 6 months of therapy. Safety evaluations will include physical examination, vital sign measurements, neurological examination, assessment of ECOG performance status, and clinical safety laboratory assessments. IVIG is recommended in pts with serum IgG <4 g/L. Follow-up of participants during the study will include monitoring for all adverse events, disease progression, and survival until end of study. By studying the feasibility and safety of administering the step-up dosing schedule in an outpatient setting, teclistamab may become more accessible to pts with RRMM and limited treatment options.

Creating a Pathway to Health-Care Professions for Historically Marginalized Students.

Developing a diverse talent pool starting at the high-school level, while students are making future education and career decisions, should be a national priority, given the need to build a diverse health-care workforce. This article describes a 6-week immersive simulation-based summer program to introduce 20 junior high-school students (13-15 years old) to the range of health professions. Because precollege students typically receive limited exposure to clinical settings, high-fidelity simulation is an excellent surrogate for providing realistic experiences in health care. Students heard lectures on health careers, earned basic life support certification, learned to perform basic vital signs measurement, practiced the management of acute asthma, and received an introduction to the daily activities in the life of a nurse and an anesthesiologist. They researched, developed, and presented public service announcement videos about a health-care issue affecting their community. Participants reported being excited about health careers. Future programs will focus on longitudinal support and mentoring, essential for mitigating the higher rates of attrition from health professions among minoritized individuals.

Deep Learning-Based Early Warning Score for Predicting Clinical Deterioration in General Ward Cancer Patients.

Cancer patients who are admitted to hospitals are at high risk of short-term deterioration due to treatment-related or cancer-specific complications. A rapid response system (RRS) is initiated when patients who are deteriorating or at risk of deteriorating are identified. This study was conducted to develop a deep learning-based early warning score (EWS) for cancer patients (Can-EWS) using delta values in vital signs. A retrospective cohort study was conducted on all oncology patients who were admitted to the general ward between 2016 and 2020. The data were divided into a training set (January 2016-December 2019) and a held-out test set (January 2020-December 2020). The primary outcome was clinical deterioration, defined as the composite of in-hospital cardiac arrest (IHCA) and unexpected intensive care unit (ICU) transfer. During the study period, 19,739 cancer patients were admitted to the general wards and eligible for this study. Clinical deterioration occurred in 894 cases. IHCA and unexpected ICU transfer prevalence was 1.77 per 1000 admissions and 43.45 per 1000 admissions, respectively. We developed two models: Can-EWS V1, which used input vectors of the original five input variables, and Can-EWS V2, which used input vectors of 10 variables (including an additional five delta variables). The cross-validation performance of the clinical deterioration for Can-EWS V2 (AUROC, 0.946; 95% confidence interval [CI], 0.943-0.948) was higher than that for MEWS of 5 (AUROC, 0.589; 95% CI, 0.587-0.560; p < 0.001) and Can-EWS V1 (AUROC, 0.927; 95% CI, 0.924-0.931). As a virtual prognostic study, additional validation was performed on held-out test data. The AUROC and 95% CI were 0.588 (95% CI, 0.588-0.589), 0.890 (95% CI, 0.888-0.891), and 0.898 (95% CI, 0.897-0.899), for MEWS of 5, Can-EWS V1, and the deployed model Can-EWS V2, respectively. Can-EWS V2 outperformed other approaches for specificities, positive predictive values, negative predictive values, and the number of false alarms per day at the same sensitivity level on the held-out test data. We have developed and validated a deep learning-based EWS for cancer patients using the original values and differences between consecutive measurements of basic vital signs. The Can-EWS has acceptable discriminatory power and sensitivity, with extremely decreased false alarms compared with MEWS.

Costing of HIV services, Uganda and United Republic of Tanzania.

To evaluate resource allocation and costs associated with delivery of human immunodeficiency virus (HIV) services in Uganda and the United Republic of Tanzania. We used time-driven activity-based costing to determine the resources consumed and costs of providing five HIV services in Uganda and the United Republic of Tanzania: antiretroviral therapy (ART); HIV testing and counselling; prevention of mother-to-child transmission; voluntary male medical circumcision; and pre-exposure prophylaxis. Country-based teams undertook time-driven activity-based costing with 1119 adults in Uganda and 886 adults in the United Republic of Tanzania. In Uganda, service delivery costs ranged from 8.18 United States dollars (US$) per visit for HIV testing and counselling to US$43.43 for ART (for clients in whom HIV was suppressed). In the United Republic of Tanzania, these costs ranged from US$3.67 per visit for HIV testing and counselling to US$28.00 for voluntary male medical circumcision. In both countries, consumables were the main cost driver, accounting for more than 60% of expenditure. Process maps showed that in both countries, registration, measurement of vital signs, consultation and medication dispensing were the steps that occurred most frequently for ART clients. Establishing a rigorous, longitudinal system for tracking investments in HIV services that includes thousands of clients and numerous facilities is achievable in different settings with a high HIV burden. Consistent engagement of implementation partners and standardized training and data collection instruments proved essential for the success of these exercises.

간호대학생 대상의 핵심간호술 실습교육 운영에 대한 주제범위 문헌고찰

Purpose : The purpose of this study was to identify the type of core nursing skills training and educational effects for Korean nursing students.&#x0D; Methods : The data was analyzed by scoping review, using the framework proposed by Arksey &amp; O'Malley (2005) and supplemented by Levac et al. (2010), was conducted. RISS, NDSL, DBpia, KISS, and KCI were used to search the literature. Two independent reviewers separately selected studies by extracting characteristics of the studies using pre-tested forms. Overall, a total of 705 articles were initially identified, out of which 40 articles were ultimately included for the final analysis.&#x0D; Result : The scenario, video taking, and peer tutoring method were observed to be the most commonly utilized educational approach for core nursing skills. The core nursing skills most frequently addressed included indwelling catheterization, vital sign measurements, intramuscular injection, and intravenous fluid infusion. When evaluating core nursing skills, the primary measurements focused on critical thinking disposition in the cognitive domain, performance confidence in the affective domain, and clinical competence in the psycho-motor domain.&#x0D; Conclusion : It is necessary to develop various operation methods for effective core nursing skills training. The findings of this study offer valuable insights that can serve as basic data for establishing effective core nursing skills training for nursing students.

Adapting remote photoplethysmography for Indonesian subjects: an examination of diverse rPPG techniques

Vital sign measurements are essential in intensive care patients, such as in the ICU or emergency department, and also for newborns or prenatal babies. The duty nurse usually monitors these vital signs by manually writing down the patient's condition on a large piece of paper in front of the patient's room. The lack of nurses can hinder the process of monitoring patient vital signs. However, since the COVID-19 pandemic, people have limited contact with their surroundings, making measuring vital signs with contact uncomfortable and unhygienic. The typical non-contact method for measuring heart rate is the remote photoplethysmography (rPPG) technique. In this study, we proposed to assess the performance of various rPPG algorithms on the Indonesian subjects dataset. The algorithms used are CHROM, GREEN, ICA, LGI, PBV, PCA, and POS on 70 pieces of data. Based on the test results with three types of evaluation metrics, namely MAE (Mean Absolute Error), RMSE (Root Mean Square Error), and Bland Altman, it is found that the measurement results with the best performance POS algorithm with a low prediction error rate with the resulting MAE value of 2.59 and RMSE of 4.65.

Safety Evaluation and Population Pharmacokinetics of Camostat Mesylate and Its Major Metabolites Using a Phase I Study.

Camostat mesylate is expected to be promising as a treatment option for COVID-19, in addition to other indications for which it is currently used. Furthermore, in vitro experiments have confirmed the potential of camostat and its metabolites to be effective against COVID-19. Therefore, clinical trials were conducted to evaluate the safety and pharmacokinetic characteristics of camostat after single-dose administration. Additionally, we aim to predict the pharmacokinetics of repeated dosing through modeling and simulation based on clinical trials. Clinical trials were conducted on healthy Korean adults, and an analysis was carried out of the metabolites of camostat, GBPA, and GBA. Pharmacokinetic modeling and simulation were performed using Monolix. There were no safety issues (AEs, physical examinations, clinical laboratory tests, vital sign measurements, and ECG) during the clinical trial. The pharmacokinetic characteristics at various doses were identified. It was confirmed that AUC last and Cmax increased in proportion to dose in both GBPA and GBA, and linearity was also confirmed in log-transformed power model regression. Additionally, the accumulation index was predicted (1.12 and 1.08 for GBPA and GBA). The pharmacokinetics of camostat for various dose administrations and indications can be predicted prior to clinical trials using the developed camostat model. Furthermore, it can be used for various indications by connecting it with pharmacodynamic information.

Efficacy of Transcutaneous 4.4 MHz Radiofrequency Diathermy versus Therapeutic Ultrasound for Pain Relief and Functional Recovery in Patients with Knee Osteoarthritis: A Randomized Controlled Study.

Knee osteoarthritis (KOA) is a prevalent common cause of disability and pain among adults. Transcutaneous radiofrequency (RF) diathermy and therapeutic ultrasound (US) are commonly employed treatments for addressing musculoskeletal conditions. This study aims to evaluate and compare the clinical effectiveness of transcutaneous 4.4 MHz RF diathermy and therapeutic US therapy in individuals diagnosed with KOA. A total of 108 patients with KOA were randomly assigned to either the RF or US groups. Each participant underwent a series of 10 treatment sessions over four weeks and was evaluated at different time points. The assessments included physical evaluations, vital sign measurements, the Numeric Rating Scale (NRS) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, the Lequesne index, gait analysis, the 36-Item Short Form Health Survey (SF-36), and analysis of adverse responses. Both groups showed significant differences in NRS, WOMAC scores, and Lequesne index compared to baseline values at both the 10th treatment session and the one-month follow-up assessment. However, no significant disparities were observed between the two groups at each assessment point. In the gait analysis, following the 10th treatment, the RF group showed significant changes in stride length and stride velocity compared to baseline. Four weeks after the completion of treatment, both groups exhibited significant alterations in stride length and stride velocity when compared to baseline measurements. However, regarding cadence, only the RF group exhibited a significant difference compared to baseline. The findings suggest that transcutaneous 4.4 MHz RF diathermy displays a comparable effectiveness to therapeutic US in reducing pain and enhancing functional capacity among individuals with KOA. Further research endeavors are warranted to advance the efficacy of noninvasive treatments for KOA.

Video plethysmography for contactless blood pressure and heart rate measurement in perioperative care.

The purpose of this study was to evaluate the feasibility and accuracy of remote Video Plethysmography (VPPG) for contactless measurements of blood pressure (BP) and heart rate (HR) in adult surgical patients in a hospital setting. An iPad Pro was used to record a 1.5-minute facial video of the participant's face and VPPG was used to extract vital signs measurements. A standard medical device (Welch Allyn) was used for comparison to measure BP and HR. Trial registration: NCT05165381. Two-hundred-sixteen participants consented and completed the contactless BP and HR monitoring (mean age 54.1 ± 16.8 years, 58% male). The consent rate was 75% and VPPG was 99% successful in capturing BP and HR. VPPG predicted SBP, DBP, and HR with a measurement bias ± SD, -8.18 ± 16.44 mmHg, - 6.65 ± 9.59 mmHg, 0.09 ± 6.47 beats/min respectively. Pearson's correlation for all measurements between VPPG and standard medical device was significant. Correlation for SBP was moderate (0.48), DBP was weak (0.29), and HR was strong (0.85). Most patients were satisfied with the non-contact technology with an average rating of 8.7/10 and would recommend it for clinical use. VPPG was highly accurate in measuring HR, and is currently not accurate in measuring BP in surgical patients. The VPPG BP algorithm showed limitations in capturing individual variations in blood pressure, highlighting the need for further improvements to render it clinically effective across all ranges. Contactless vital signs monitoring was well-received and earned a high satisfaction score.

Automated measurement of distance-walked as a “sixth vital sign” for detecting infusion reactions during preclinical testing

Infusion reactions are a major risk for advanced therapeutics (e.g., engineered proteins nanoparticles, etc.), which can trigger the complement cascade, anaphylaxis, and other life-threatening immune responses. However, during the early phases of development, it is uncommon to assess for infusion reactions, given the labor involved in measuring multiple physiological parameters in rodents. Therefore, we sought to develop an automated quantification of rodent locomotion to serve as a sensitive screening tool for infusion reactions, with minimal added labor-time for each experiment. Here we present the detailed methods for building a motion tracking cage for mice, requiring ∼$100 of materials, ∼2 h to build and set up completely, and employing freely available software (DeepLabCut). The distance-walked after injection was first shown to have the predicted effects for stimulants (caffeine), sedatives (ketamine), and toxins (lipopolysaccharide). Additionally, the distance-walked more sensitively detected the effects of these compounds than did pulse oximetry-based measurements of the classical vital signs of heart rate, respiratory rate, and blood oxygen saturation. Finally, we examined a nanomedicine formulation that has been in preclinical development, liposomes targeted to the cell adhesion molecule ICAM. While this formulation has been studied across dozens of publications, it has not previously been noted to produce an infusion reaction. However, the automated motion tracking cage showed that ICAM-liposomes markedly reduce the distance-walked, which we confirmed by measuring the other vital signs. Importantly, the motion tracking cage added < 5 min of labor time per 5-mouse condition, while pulse oximetry with a neck cuff (by far the most stable oximetry signal in mice) required ∼ 100 min of labor time. Thus, automated measurement of distance-walked can indeed serve as a “sixth vital sign” for detecting infusion reactions during preclinical testing. Additionally, the device to measure distance-walked is easy and cheap to build and requires negligible labor time for each experiment, enabling distance-walked to be recorded in nearly every infusion experiment.

Feasibility of combined ultrasound guided interscalene and erector spinae plane block for regional anesthesia in modified radical mastectomy with axillary lymph node dissection: A pilot study

ABSTRACT Background In patients at high risk, regional anesthesia (RA) is a viable substitute for general anesthesia (GA). For a modified radical mastectomy that included axillary lymph node dissection (MRM-ALND), we assumed that a combination erector spinae plane block (ESPB) and interscalene block (IBPB) could offer a sufficient anesthesia. Methods After clinical trial registration (No. NCT04239716), this pilot study included thirteen consecutive female, 40–85 years old, and scheduled for MRM-ALND. Patients received ESPB at T4 level (5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine, and 5 ml of normal saline), IBPB (5 ml each of 2% lidocaine and 0.5% bupivacaine), and sedation with dexmedetomidine. The primary aim was to assess the success rate of our technique as a sole anesthesia for MRM-ALND in high-risk patients. Secondary outcomes included intraoperative vital signs measurements. Postoperative measurements were numeric rating scale (NRS) score, analgesic duration, the consumption of morphine, patients’ satisfaction, and adverse effects. Results Our technique succeeded in 11 out of 13 patients. In whom RA were succeeded, the analgesia lasted 360–720 minutes, they received morphine 3–9 mg and had low NRS scores. The two failure cases received GA, the analgesia lasted 60–120 minutes postoperative, they received morphine 9 mg and had high NRS scores. The reduction of hemodynamic parameters intraoperative responded to reduce dexmedetomidine infusion rate. Two patients had postoperative vomiting treated with ondansetrone. Conclusions The combined ESPB and IBPB could be utilized as an alternative to GA for MRM-ALND, which reduced the potential risks of GA in high-risk patients; furthermore, it provides satisfactory postoperative analgesia with limited opioid consumption.

Evaluation of the comparative pharmacokinetic properties of a new orally disintegrating tablet of tegoprazan in healthy Korean subjects.

Tegoprazan is a differentiated gastric acid-pump blocker and belongs to a class of potassium-competitive acid secretion blockers. An orally disintegrating tablet (ODT) of tegoprazan was developed to improve patient compliance. The purpose of this study was to compare pharmacokinetics (PK) and safety profiles between the conventional tablet (as the reference drug) and the ODT (as the test drug) of 50 mg tegoprazan in healthy Korean subjects. An open-label, randomized, single-dose, 6-sequence, 3-period crossover study was conducted in 48 healthy subjects. All subjects received a single oral dose of tegoprazan 50mg tablet with water, tegoprazan 50mg ODT with water, and tegoprazan 50mg ODT without water. Serial blood samples were collected up to 48hours after dosing. Plasma concentrations of tegoprazan and its metabolite M1 were measured by LC-MS/MS, and PK parameters were calculated with a non-compartmental method. Safety was evaluated by means of assessed adverse events, physical examinations, laboratory test results as well as measurements of vital signs and ECG throughout the study. A total of 47 subjects completed the study. The 90% confidence intervals of the geometric mean ratios for AUCt, Cmax, and AUCinf of tegoprazan were 0.8873-0.9729, 0.8865-1.0569, and 0.8835-0.9695 for the test drug with water to the reference drug and 0.9169-1.0127, 0.9569-1.1276, and 0.9166-1.0131 for the test drug without water to the reference drug, respectively. There were no serious adverse events, and all adverse events were mild. The PK profiles of tegoprazan were equivalent between the conventional tablet and ODT with or without water. There was no significant difference in the safety profiles. Therefore, the novel ODT of tegoprazan that can be taken without water may improve compliance among patients with acid-related diseases.

Oxygen Saturation and Heart Rate Monitoring System by Mobile

COVID-19 changed the way people live, causing a high mortality rate and making the entire health system in the world difficult due to the lack of equipment and infrastructure, causing many people to be treated from home, constantly measuring their saturation level and heart rate with the help of a pulse oximeter, since the virus directly affects the respiratory system, it has been added that people with lung or cardiovascular problems also have to perform the constant measurement of both vital signs to visualize that they are in a normal range, otherwise, they would have to attend a medical center, so it is important to monitor both vital signs. In view of this problem, in this article a monitoring system of oxygen saturation and heart rate was carried out by mobile application, in such a way that both vital signs can be constantly monitored and an alert can be given to the health center with the coordinates of the person when the system detects a measurement outside the normal range, with this, it would help people who may need medical attention immediately, being able to save their lives. Through the development of the monitoring system, it was possible to observe the operation of the mobile application with an efficiency of 99.15% in monitoring the level of oxygen saturation and 98.78% in monitoring the heart rate, taking 4 seconds to send the alert to the health center to assist the patient.

Early Warning Scores to Support Continuous Wireless Vital Sign Monitoring for Complication Prediction in Patients on Surgical Wards: Retrospective Observational Study.

Wireless vital sign sensors are increasingly being used to monitor patients on surgical wards. Although early warning scores (EWSs) are the current standard for the identification of patient deterioration in a ward setting, their usefulness for continuous monitoring is unknown. This study aimed to explore the usability and predictive value of high-rate EWSs obtained from continuous vital sign recordings for early identification of postoperative complications and compares the performance of a sensor-based EWS alarm system with manual intermittent EWS measurements and threshold alarms applied to individual vital sign recordings (single-parameter alarms). Continuous vital sign measurements (heart rate, respiratory rate, blood oxygen saturation, and axillary temperature) collected with wireless sensors in patients on surgical wards were used for retrospective simulation of EWSs (sensor EWSs) for different time windows (1-240 min), adopting criteria similar to EWSs based on manual vital signs measurements (nurse EWSs). Hourly sensor EWS measurements were compared between patients with (event group: 14/46, 30%) and without (control group: 32/46, 70%) postoperative complications. In addition, alarms were simulated for the sensor EWSs using a range of alarm thresholds (1-9) and compared with alarms based on nurse EWSs and single-parameter alarms. Alarm performance was evaluated using the sensitivity to predict complications within 24 hours, daily alarm rate, and false discovery rate (FDR). The hourly sensor EWSs of the event group (median 3.4, IQR 3.1-4.1) was significantly higher (P<.004) compared with the control group (median 2.8, IQR 2.4-3.2). The alarm sensitivity of the hourly sensor EWSs was the highest (80%-67%) for thresholds of 3 to 5, which was associated with alarm rates of 2 (FDR=85%) to 1.2 (FDR=83%) alarms per patient per day respectively. The sensitivity of sensor EWS-based alarms was higher than that of nurse EWS-based alarms (maximum=40%) but lower than that of single-parameter alarms (87%) for all thresholds. In contrast, the (false) alarm rates of sensor EWS-based alarms were higher than that of nurse EWS-based alarms (maximum=0.6 alarm/patient/d; FDR=80%) but lower than that of single-parameter alarms (2 alarms/patient/d; FDR=84%) for most thresholds. Alarm rates for sensor EWSs increased for shorter time windows, reaching 70 alarms per patient per day when calculated every minute. EWSs obtained using wireless vital sign sensors may contribute to the early recognition of postoperative complications in a ward setting, with higher alarm sensitivity compared with manual EWS measurements. Although hourly sensor EWSs provide fewer alarms compared with single-parameter alarms, high false alarm rates can be expected when calculated over shorter time spans. Further studies are recommended to optimize care escalation criteria for continuous monitoring of vital signs in a ward setting and to evaluate the effects on patient outcomes.

Improving the Quality of Postpartum Care in Ghana: Protocol for a Parallel Randomized Controlled Trial.

Although the postpartum period poses substantial risks and can result in significant maternal morbidity and mortality, postpartum care of the mother receives much less attention in transitional countries. We describe the protocol for a randomized controlled trial to implement and evaluate a postpartum care delivery model titled Focused-PPC (Focused Postpartum Care). Focused-PPC is an integrated group postpartum care model that meets the clinical care, education, and support needs of mothers up to 1 year after birth. The Focused-PPC intervention is a parallel randomized controlled trial with a total of 192 postpartum women at 4 health centers in Tamale, Ghana. Participants will be randomized into 1 of 2 trial arms at a 1:1 allocation ratio: (1) the control arm, which receives the standard postnatal care currently delivered in health facilities, or (2) the intervention arm, which receives the Focused-PPC model of care. Women enrolled in the intervention arm will receive postpartum clinical assessments and education for the first 6 weeks and will continue to receive education, measures of vital signs, and peer support for 12 months post partum during child welfare visits. Led by trained midwives, each postpartum group in the intervention arm will meet at 1-2 weeks, 6 weeks, and monthly thereafter for up to 1 year post partum, following the Ghana Health Service postnatal care schedule. The Focused-PPC guide, data collection tools, and audiovisual education materials were successfully developed and translated into the local language. We have enrolled and conducted baseline surveys for 192 women (sample size met) in the Focused-PPC trial who have been randomized into intervention and control arms. We have established a total of 12 Focused-PPC groups in the intervention arm, 3 groups from each site, all of which have sessions underway. Focused-PPC has the potential to change the postpartum care delivery model in Ghana and other countries in sub-Saharan Africa and beyond. ClinicalTrials.gov NCT05280951; https://clinicaltrials.gov/study/NCT05280951. DERR1-10.2196/47519.

A wearable medical sensors system for in-situ monitoring vital signs of patients with hemorrhagic shock in big disaster scenes

In big disaster sites, such as earthquakes, wars, and traffic accidents, monitoring the vital signs of people with hemorrhagic shock is crucial for accurate injury classification and timely rescue. Clinical medical equipment is unsuitable for in-situ detection since large size and complex operations. In this paper, we propose a set of wearable medical sensors system that integrates bio-radar, wristwatch, nose clip, and biochemical sensor to monitor the vital signs of patients in big disaster scenes. This system offers portable advantages over bulky medical equipment and flexible measurement of blood pressure, heart rate, blood oxygen saturation, respiratory rate, body temperature, and levels of glucose, lactate, and hemoglobin (Hb). By addressing individual differences and improving the signal-to-noise ratio, the sensors system can achieve highly sensitive measurements online. Experimental studies on 15 patients in ICU wards reveal high uniformity of measurement results between our wearable sensors system and clinical equipment. Based on the data collected by the wearable sensor system and processed through a pre-established assessment model, color labels indicating severity levels will be presented to classify the injury degree for efficient rescue. Our proposed wearable medical sensor system contributes to saving more lives in big disaster scenes through accurate and timely measurement of vital signs.

Prehospital Early Warning Scores to Predict Mortality in Patients Using Ambulances

Early warning scores (EWSs) are designed for in-hospital use but are widely used in the prehospital field, especially in select groups of patients potentially at high risk. To be useful for paramedics in daily prehospital clinical practice, evaluations are needed of the predictive value of EWSs based on first measured vital signs on scene in large cohorts covering unselected patients using ambulance services. To validate EWSs' ability to predict mortality and intensive care unit (ICU) stay in an unselected cohort of adult patients who used ambulances. This prognostic study conducted a validation based on a cohort of adult patients (aged ≥18 years) who used ambulances in the North Denmark Region from July 1, 2016, to December 31, 2020. EWSs (National Early Warning Score 2 [NEWS2], modified NEWS score without temperature [mNEWS], Quick Sepsis Related Organ Failure Assessment [qSOFA], Rapid Emergency Triage and Treatment System [RETTS], and Danish Emergency Process Triage [DEPT]) were calculated using first vital signs measured by ambulance personnel. Data were analyzed from September 2022 through May 2023. The primary outcome was 30-day-mortality. Secondary outcomes were 1-day-mortality and ICU admission. Discrimination was assessed using area under the receiver operating characteristic curve (AUROC) and area under the precision recall curve (AUPRC). There were 107 569 unique patients (52 650 females [48.9%]; median [IQR] age, 65 [45-77] years) from the entire cohort of 219 323 patients who used ambulance services, among whom 119 992 patients (54.7%) had called the Danish national emergency number. NEWS2, mNEWS, RETTS, and DEPT performed similarly concerning 30-day mortality (AUROC range, 0.67 [95% CI, 0.66-0.68] for DEPT to 0.68 [95% CI, 0.68-0.69] for mNEWS), while qSOFA had lower performance (AUROC, 0.59 [95% CI, 0.59-0.60]; P vs other scores < .001). All EWSs had low AUPRCs, ranging from 0.09 (95% CI, 0.09-0.09) for qSOFA to 0.14 (95% CI, 0.13-0.14) for mNEWS.. Concerning 1-day mortality and ICU admission NEWS2, mNEWS, RETTS, and DEPT performed similarly, with AUROCs ranging from 0.72 (95% CI, 0.71-0.73) for RETTS to 0.75 (95% CI, 0.74-0.76) for DEPT in 1-day mortality and 0.66 (95% CI, 0.65-0.67) for RETTS to 0.68 (95% CI, 0.67-0.69) for mNEWS in ICU admission, and all EWSs had low AUPRCs. These ranged from 0.02 (95% CI, 0.02-0.03) for qSOFA to 0.04 (95% CI, 0.04-0.04) for DEPT in 1-day mortality and 0.03 (95% CI, 0.03-0.03) for qSOFA to 0.05 (95% CI, 0.04-0.05) for DEPT in ICU admission. This study found that EWSs in daily clinical use in emergency medical settings performed moderately in the prehospital field among unselected patients who used ambulances when assessed based on initial measurements of vital signs. These findings suggest the need of appropriate triage and early identification of patients at low and high risk with new and better EWSs also suitable for prehospital use.