Changes In Vital Signs Research Articles

Regional cerebral oxygen saturation during initial mobilization of critically ill patients is associated with clinical outcomes: a prospective observational study

BackgroundVital signs help determine the safety of early mobilization in critically ill patients in intensive care units. However, none of these variables directly assess cerebral circulation. Therefore, we aimed to investigate the relationship of regional cerebral oxygen saturation (rSO2) and vital signs with in-hospital death in critically ill patients.MethodsThis prospective study included critically ill patients admitted to the Uonuma Kikan Hospital Emergency Center who received physical therapy between June 2020 and December 2022. We continuously measured rSO2 during the initial mobilization using a wearable brain near-infrared spectroscopy device. With in-hospital death as the primary endpoint, the association between rSO2 and in-hospital death was assessed in Analysis 1 to determine the rSO2 cut-off value that predicts in-hospital death. In Analysis 2, patients were categorised into survival and non-survival groups to examine the temporal changes in vital signs and rSO2 associated with postural changes during mobilization.ResultsOf the 132 eligible patients, 98 were included in Analysis 1, and 70 were included in Analysis 2. Analysis 1 demonstrated that lower premobilization rSO2 was independently associated with in-hospital death (odds ratio 0.835, 95% confidence interval 0.724–0.961, p = 0.012). Receiver operating characteristic curve analysis identified an optimal rSO2 cut-off value of 57% for predicting in-hospital death (area under the curve 0.818, sensitivity 73%, specificity 83%). Analysis 2 showed that rSO2 changes during mobilization were unrelated to changes in vital signs, suggesting rSO2 as an independent prognostic marker.ConclusionsThe results suggest that rSO2 measured during initial mobilization is associated with in-hospital death in critically ill patients.

The effects of lutein/ zeaxanthin (Lute-gen®) on eye health, eye strain, sleep quality, and attention in high electronic screen users: a randomized, double-blind, placebo-controlled study

BackgroundLutein and zeaxanthin are fat-soluble antioxidant nutrients that have evidence of beneficial effects on vision and eye health.PurposeExamine the effects of supplementation with lutein and zeaxanthin isomers (Lute-gen®) on eye health, eye strain, sleep quality, and attention in high electronic screen users.Study designTwo-arm, 6-month, parallel-group, randomized, double-blind, placebo-controlled trial.MethodsSeventy volunteers aged 18 to 65 who used electronic screens for more than 6 h daily were supplemented with 10 mg of lutein and 2 mg of zeaxanthin-isomers or a placebo. Outcome measures included several ophthalmic examinations comprising the Schirmer tear test, photo-stress recovery time, contrast sensitivity, tear film break-up time, and self-report measures of visual fatigue, computer vision, sleep quality and attention.ResultsCompared to the placebo, lutein and zeaxanthin supplementation was associated with greater improvements in the Schirmer tear test, photo-stress recovery time, and tear film break-up time. However, there were no between-group differences in the change in self-report measures or contrast sensitivity. Lutein and zeaxanthin supplementation was well-tolerated, with no reports of serious adverse reactions or clinically significant changes in safety blood measures, including liver function, renal function, blood lipids, and full blood examination.ConclusionThe results from this study provide support for the beneficial effects of 6 months of lutein and zeaxanthin supplementation on regular users of electronic screens. Compared to the placebo, there were improvements in several ophthalmic examinations for dry eyes and visual health. However, these findings were not corroborated by group differences in the administered self-report measures. Lutein and zeaxanthin were well tolerated, with no serious adverse effects or significant changes in vital signs or blood safety measures.

Comparison of the incidence of recovery agitation with two different doses of ketamine in procedural sedation: A randomized clinical trial.

The objective was to compare the incidence of recovery agitation and efficacy of two different intravenous (IV) doses of ketamine (0.5 mg/kg vs. 1 mg/kg) in adult patients who presented to the emergency department (ED) requiring procedural sedation with ketamine. This randomized, prospective clinical trial included patients aged 18-75 years who required procedural sedation with ketamine in the ED. Patients were randomized to receive IV ketamine at either 0.5 mg/kg (low dose) or 1 mg/kg (high dose). The primary outcome was the incidence of recovery agitation, assessed by the Richmond Agitation-Sedation Scale (RASS) at 5, 15, and 30 min following the procedure, in both dosage groups. Secondary outcomes included overall efficacy, sedation duration, and changes in vital signs. A total of 108 patients were enrolled in the study, 54 in each group. The median (IQR) RASS scores at 5, 15, and 30 min were -4 (-5 to -4), -1 (-1.3 to 0), and 0 (-1 to 0.5), respectively, in the low-dose group and -4 (-5 to -4), -1 (-3 to 0), and 0 (0 to 0), respectively, in the high-dose group. The incidence of recovery agitation was similar between the low- and high-dose groups (difference 1.9%, 95% confidence interval [CI] -14.8% to 18.4%). No significant difference was observed in sedation duration between the two groups (difference 0%, 95% CI -3.0% to 4.0%). While no additional ketamine was required in the high-dose group, four patients (7.4%) in the low-dose group required an additional half-dose (difference 7.4%, 95% CI -2.3% to 18.7%). Changes in vital signs were similar between the two groups. There was no significant difference in recovery agitation, sedation duration, and changes in vital signs between 0.5 and 1 mg/kg IV ketamine for procedural sedation in the ED.

P-1243. Evaluation of Single and Multiple Dose Safety and Pharmacokinetics of Ledaborbactam Etzadroxil and Ceftibuten-Ledaborbactam Etzadroxil in Healthy Volunteers

Abstract Background Ledaborbactam etzadroxil (LED-E), a novel oral prodrug that converts to the active β-lactamase inhibitor ledaborbactam (LED), is being developed in combination with ceftibuten (CTB) to address the urgent need for new oral (PO) treatments against drug-resistant gram-negative infections. Methods In part 1, healthy participants (PT) received single (100mg to 1000mg) or multiple (75mg to 500mg q8h for 10 days) PO doses of LED-E or matching placebo (PBO); PTs in Part 2 received single doses of LED-E 500mg, CBT 400mg, and LED-E+CTB 500mg+400mg; Part 3 PT received LED-E+CTB 300mg+400mg, LED-E+CTB 500mg+400mg or PBO q8h for 10 days. Serial blood and urine samples were obtained to determine single dose and steady-state plasma PK of CTB, LED-E, and LED. Safety was assessed by recording adverse events (AE), and changes in laboratory, vital signs, and ECGs. Results AUC of LED-E was ≤ 2% of exposures of LED across the dose range tested, suggesting extensive conversion of the prodrug to the active drug. LED exposures increased in a generally dose proportional manner across single LED-E doses from 100mg to 1000mg and multiple doses from 75mg to 500mg q8h. The terminal half-life of LED in plasma is approximately 11-12 h, with 30-35% accumulation of LED following q8h dosing of LED-E. Excretion in urine of LED-E derived material was 84.4% over the 8-hour dosing interval at steady state. No clinically relevant changes in the pharmacokinetics of CTB, LED, or LED-E occurred when CTB and LED-E were co-administered compared to each administered alone (Table 1). The number of participants with treatment-emergent AEs (TEAE) was similar in the LED-E (+/- CTB) (81.7%) and PBO (77.8%) groups. Headache and nausea were the most frequently reported TEAEs in LED-E dosed PTs (Table 2). Most events were mild and only 1 TEAE led to drug discontinuation. No serious adverse events or deaths occurred. No clinical relevant changes were noted in clinical labs, ECGs, or vital signs Conclusion LED exposure increased in a dose proportional manner. No clinically relevant drug-drug interaction was observed between LED and CTB When LED-E and CTB are co-administered. LED-E was safe and well tolerated when given with CTB at multiple doses up to 1500mg daily for 10 days. Disclosures Carlos Fernando de Oliveira, MD, PhD, MS, Venatorx Pharmaceuticals: Stocks/Bonds (Private Company) Mary Beth Dorr, PhD, Merck: Stocks/Bonds (Public Company)|Pfizer: Stocks/Bonds (Public Company)|Venatorx: Stocks/Bonds (Private Company) Kathryn Lowe, MS, Venatorx Pharmaceuticals: Stocks/Bonds (Private Company) Gregory A. Winchell, PhD, Certara: Advisor/Consultant|Merck: Advisor/Consultant|Venatorx: Advisor/Consultant Paul McGovern, MD, Venatorx Pharmaceuticals, Inc.: employee|Venatorx Pharmaceuticals, Inc.: Stocks/Bonds (Private Company)

P-1230. Dose-Escalation Study to Evaluate the Pharmacokinetics and Safety of Single and Repeat Doses of Ceftibuten in Healthy Participants

Abstract Background Venatorx is developing ledaborbactam etzadroxil (LED-E), the prodrug of the active β-lactamase inhibitor ledaborbactam, in combination with ceftibuten (CTB), to address an unmet medical need for new oral (PO) agents to treat serious infections caused by drug resistant pathogens. Cis-CTB is the highly active isomer of CTB. The purpose of this study was to evaluate the pharmacokinetics (PK) and safety of CTB in healthy adult subjects at potential doses to be studied in combination with LE. Methods Thirty-six participants (PT), 12 per cohort (CTB 9, placebo, PBO 3) received a single PO dose of CTB (400, 800, or 1200mg) or matched PBO on Day 1. Following a one-day washout period, the same PT received repeat PO doses of CEF (400mg daily, 400mg q12h, or 400mg q8h) for 10 days. Serial blood samples and urine were collected for determination of single dose and steady-state plasma PK and urinary excretion of cis- and trans-CTB. Safety was assessed by recording adverse events, and changes in safety laboratory, vital signs, and ECGs. Results Geometric mean (%CV) cis- and trans-CTB PK parameters for single and multiple doses are shown in Table 1. AUC(0-τ) and AUC∞, appeared to increase in a dose proportional manner, while maximum concentrations (Cmax) appeared to increase in a less than dose proportional manner across the entire dose range in the single dose part of the study. Low levels of accumulation of cis-CTB were observed at steady state, with the highest accumulation ratio of 1.24 in the 400mg q8h cohort. Cis-CTB and trans-CTB recovery in urine was 47% and 6% following a 1200mg single dose, respectively. The incidence of treatment-emergent adverse events (TEAEs) was comparable between the CTB and PBO groups across cohorts. Of the 36 PT, 25 (CTB 67%, PBO 78%) reported 65 TEAEs. Nausea, headache, and fatigue were the most reported TEAEs in CTB-treated participants. TEAEs occurring in > 1 PT receiving CTB are listed in Table 2. No significant changes were noted in clinical labs, ECGs, or vital signs, and there were no serious AEs, drug-related discontinuations, or deaths. Conclusion Cis-CTB exposure (AUC) increased in a dose proportional manner. Single doses of CTB up to 1200 mg and multiple doses of CTB up to 400mg doses q8h for 10 days were safe and well tolerated. Disclosures Mary Beth Dorr, PhD, Merck: Stocks/Bonds (Public Company)|Pfizer: Stocks/Bonds (Public Company)|Venatorx: Stocks/Bonds (Private Company) Carlos Fernando de Oliveira, MD, PhD, MS, Venatorx Pharmaceuticals: Stocks/Bonds (Private Company) Kathryn Lowe, MS, Venatorx Pharmaceuticals: Stocks/Bonds (Private Company) Gregory A. Winchell, PhD, Certara: Advisor/Consultant|Merck: Stocks/Bonds (Public Company)|Venatorx: Advisor/Consultant Paul McGovern, MD, Venatorx Pharmaceuticals, Inc.: employee|Venatorx Pharmaceuticals, Inc.: Stocks/Bonds (Private Company)

Effects of Songs Recorded by Parents on the Vital Signs of Preterm Infants: A Randomized Controlled Trial

Background: Preterm infants often have unstable vital signs and prolonged hospital stays that can hinder parent–infant bonding, especially under COVID-19 restrictions. This study aimed to evaluate whether listening to songs recorded by parents was effective in stabilizing the condition of premature infants. Methods: This randomized controlled study was conducted at the University of Miyazaki Hospital from October 2022 to March 2024 during the COVID-19 pandemic period. The participants were preterm infants born at less than 33 weeks gestation and their parents, all of whom recorded songs. The recorded songs were played daily to the infants in the intervention group, while the control group received usual care. Primary outcomes included vital signs (respiratory rate, pulse oximetry saturation, heart rate) and activity level. Results: Data for 33 preterm infants (intervention, n = 17 [total 749 sessions]; control, n = 16 [total 721 sessions]) were analyzed for changes in vital signs and activity levels. The intervention reduced infants’ respiratory rates (4.1 [95% CI: 2.5–5.6], p < 0.001) and slightly but statistically significantly increased pulse oximetry saturation (0.6 [95% CI: 0.02–1.2], p < 0.044). Conclusions: Recorded parental songs were found to safely stabilize the respiratory status of preterm infants and may serve as an accessible intervention to support parent–infant attachment, particularly in settings with restricted parental visitation.

Dynamic pathophysiological features of early primary blast lung injury: a novel functional incapacity pig model

IntroductionWhile there is evidence supporting the use of ultrasound for real-time monitoring of primary blast lung injury (PBLI), uncertainties remain regarding the timely detection of early PBLI and the limited data correlating it with commonly used clinical parameters. Our objective is to develop a functional incapacity model for PBLI that better addresses practical needs and to verify the early diagnostic effectiveness of lung ultrasound in identifying PBLI.MethodsWe selected six healthy male pigs to develop an animal model using a bio-shock tube (BST-I). The injuries were induced at a pressure of 4.8 MPa. We monitored the animals before and after the injury using various methods to detect changes in vital signs, lung function, and hemodynamics.ResultsThe experimental peak overpressure was measured at 405.89 ± 4.14KPa, with the duration of the first positive peak pressure being 50.01ms. The mortality rate six hours after injury was 50%. The average Military Combat Injury Scale was higher than 3. Significant increases were observed in heart rate (HR), shock index (SI), alveolar-arterial oxygen gradient (AaDO2), lung ultrasound scores(LUS), and pulmonary vascular permeability index (PVPI) at 0.5 h, 3 h, and 6 h after-injury (p < 0.05). Conversely, there were notable decreases in average arterial pressure(MAP), oxygenation index (OI), stroke volume per heartbeat(SV), cardiac output power index(CPI), global end-diastolic index (GEDI), and intrathoracic blood volume index (ITBI) during the same time periods (p < 0.05). Meanwhile, the extrapulmonary water index (ELWI) showed a significant increase at 0.5 h and 6 h after injury (p < 0.05). At 6 h after injury, pulmonary ultrasound scores were positively correlated with HR (R = 0.731, p < 0.001), AaDO2 (R = 0.612, p = 0.012), SI (R = 0.661, p = 0.004), ELWI (R = 0.811, p < 0.001), PVPI (R = 0.705, p = 0.002). In contrast, these scores were negatively correlated with SpO2 (R = -0.583, p = 0.007),OI (R = -0.772, p < 0.001), ITBI (R = -0.637, p = 0.006).ConclusionWe have successfully developed a novel, and highly reproducible animal model for assessing serious PBLI functional incapacity. This model displays immediate symptoms of hypoxia, decreased cardiac output, decreased blood volume, and abnormal lung ultrasound findings within 0.5 h of injury, with syptoms lasting for up to 6 h. Lung ultrasound evaluation is crucial for the early assessment of injuries, and is comparable to commonly used clinical parameters.

A retrospective Study on Intestinal Injury from Blunt Abdominal Trauma

Introduction: Blunt abdominal trauma is the primary cause of morbidity and mortality. Suppose there are no indications of external trauma or changes in the patient's vital signs; blunt abdominal injuries might be complicated to identify at first. It is possible to lose a significant amount of blood without the abdomen appearing significantly different. A direct blow from blunt trauma can result in visceral damage and solid organ rupture, which can cause hemorrhage, peritonitis, and related pelvic injuries. The liver, small bowel, and spleen are the most frequently injured organs. Objectives: To find out the etiology, manifestation, anatomical distribution, diagnostic method, management, and outcome of intestinal injuries from blunt abdominal trauma. Material and Methods: About 59 individuals who had laparotomies during a 3-year period to treat intestine damage from traumatic abdominal trauma were included in the research. In a retrospective analysis, the patients' causes, presentations, anatomical distributions, diagnostic techniques, related injuries, courses of therapy, and deaths were all examined. Results: About 59 individuals with 60 significant bowel and mesentery lesions from blunt abdominal trauma were conducted. The average age was 36.78 years, and the male-to-female ratio was 5.5: 1. About 60 people sustained severe injuries. Furthermore, there were 50 minor intestinal injuries, which included 48 perforations, 12 major seromuscular injuries, and seven mesenteric, eleven colonic, and one duodenal injury. Thirty-three individuals suffered injuries from automobile incidents. The most frequent damage was a perforation at the small bowel's antimesenteric boundary. For colonic perforations, treatment included protective colostomy after resection, anastomosis, and perforation repair. There were 2 (3.38%) documented fatalities, and 10 (16.9%) individuals experienced significant problems. Conclusion: Due to its enormous infectious potential, early detection of intestinal injuries following severe abdominal trauma is crucial, even if it might be challenging. Severe injuries are frequently linked to intestinal perforations and are likely the deciding factors in survival.

Physiological and behavioral stability of newborns on therapeutic hypothermia for hypoxic-ischemic encephalopathy during parental holding.

Physical separation contributes to parental trauma and poor bonding in the context of therapeutic hypothermia (TH) for hypoxic-ischemic encephalopathy (HIE). Parental holding (PH) may improve parents' experience. We aim to determine the physiological and behavioral stability of the newborn held by the parents during TH. Observational, prospective, single-center study which included 30 newborns with mean gestational age of 39 (1.8) weeks and mean birth weight 3165 (508) g, with HIE treated by TH, whom parents wanted to hold. All infants were mechanically ventilated and received sedation-analgesia. Main outcome was change in body temperature (> 34°C or < 33 °C) during PH. Secondary outcomes were change in vital signs and behavior (comfort/pain scores) during PH. Parental and nurses' opinions were assessed by a self-reporting questionnaire with a 10-point Likert scale. We found no significant changes in temperature, other vital signs or in infants' COMFORT-B score during parental holding. Responses to self-reporting questionnaires completed by parents and nurses showed a high level of overall effectiveness and satisfaction with PH. Parents holding newborns undergoing therapeutic hypothermia for hypoxic-ischemic encephalopathy was safe for the newborn without causing discomfort. It was also beneficial for the parents and supported by the healthcare team. Parents holding newborns undergoing therapeutic hypothermia for Hypoxic Ischemic Encephalopathy was feasible without causing discomfort. It was also beneficial for the parents and supported by the healthcare team. Infants' temperature or other vital signs did not change during parental holding, which was found very satisfactory by parents and healthcare givers, showing that parental holding is feasible. This study promotes further dissemination of parental holding, which may limit the detrimental effect of physical separation for parents of newborns undergoing therapeutic hypothermia.

Nurse worry as a trigger for rapid response team activation improving outcomes: a retrospective cohort study in non-critical units.

Patients hospitalized outside of monitored environments may experience sudden clinical worsening requiring transfer to the Intensive Care Unit. Early detection based on the clinical nurse's identification of the risk of clinical deterioration represents an opportunity to prevent serious adverse events. Nurse worry is defined as the use of clinical reasoning combined with intuition that precedes the patient's clinical deterioration. The objective of this study was to evaluate nurse worry as a trigger for rapid response team activation in patients hospitalized in non-critical units and its association with the need in ICU admission. This retrospective cohort study utilized data retrieved from an anonymized institutional database used to monitor the actions of the rapid response team. Data collected from January 2021 to December 2022 were analyzed, encompassing patients over 18 years old admitted to non-critical units and evaluated by the rapid response team. Analyzed variables included demographic characteristics, MEWS score, and causes for activating the rapid response team, such as changes in vital signs and nurse worry. Main outcomes assessed were transfer to the ICU, medical procedures, and drug administration. Patients were divided into three groups for analysis: those triggered for RRT assessment exclusively by changes in vital signs, those triggered exclusively by nurse worry and those triggered by the nurse worry combined with changes in vital signs. A total of 4634 rapid response team consultations were included, with 1574 triggered by changes in vital signs, 1263 triggered by nurse worry and 1797 triggered by the nurse worry associated with changes in vital signs. The group with nurse concern showed a lower need for transfers to the ICU (40%) compared to the group with changes in vital signs (50%) p < 0.001 although there was no difference in relation to the need for medical procedures,17% in both groups. The NW emerges as a relevant factor in triggering RRT and may be associated with improved outcomes, such as reduced need for ICU transfers. However, the observational design of the study does not allow for establishing causal relationships.

Clinical Pharmacokinetics of Atogepant in Healthy Japanese and White Adults.

Atogepant is a calcitonin gene-related peptide receptor antagonist approved for the preventive treatment of migraine in adults in the USA, EU, and several other countries. The objectives of this study were to evaluate the pharmacokinetics (PK) and dose proportionality of atogepant in healthy Japanese participants, evaluate the safety and tolerability of atogepant in Japanese participants, and explore the differences in the PK and safety of atogepant in Japanese vs white participants. A total of 50 participants (40 Japanese and 10 white) were enrolled into five cohorts; Japanese cohorts were randomized in a 4:1 ratio to atogepant (10mg, 30mg, or 60mg daily dosing and 60mg twice daily) or placebo. The white participants were randomized to atogepant (60mg twice daily) or placebo. Doses were administered on day 1 and days 3-8, with those on days 1 and 8 administered after an overnight fast. In Japanese participants, atogepant exposure increased with dose, and there was no accumulation with once-daily dosing and minimal (~ 20%) accumulation with twice-daily dosing. Atogepant steady-state exposure appeared to be marginally lower in Japanese participants compared with white participants and was well tolerated. There were no treatment-related adverse events, serious adverse events, clinically significant changes in vital signs, or signs of suicidal ideation or behaviors. Atogepant exposure increased with dose in healthy Japanese participants and was well tolerated within the dose range tested.

Early Clinical Deterioration Risk Assessment in Inpatient Units of a Public University Hospital

Background: Clinical deterioration occurs due to changes in vital signs, which can be identified early to prevent negative outcomes. We used the NEWS2 system to assess the potential for early clinical deterioration in adult inpatient units at a public university hospital in southeastern Brazil. Materials and Methods: This was an exploratory study conducted at a public hospital in southeastern Brazil, following the guidelines of the Reporting of Strengthening Observational Studies in Epidemiology (STROBE) initiative. Data was collected from January to April 2021, involving 251 inpatients. A questionnaire was used to gather sociodemographic and clinical data, and the Brazilian version of NEWS2 was used to assess the risk of clinical deterioration. Data analysis included descriptive analyses, linear correlation tests, and comparative tests. Results: The average NEWS2 score was 2.9 points among 251 patients, indicating a moderate level of care complexity and recommending assessment by a registered nurse every 4–6 hours. There was no significant correlation between age and NEWS2 score, but the NEWS2 score was significantly higher for men. Conclusions: This study highlights the necessity of using robust assessment tools to evaluate the risk of early clinical deterioration, enabling clinicians to manage patient conditions effectively.

Automated Smart Healthcare Monitoring System

This research presents the design and implementation of a fully automated chair equipped with sensors to assess the health status of patients. The chair measures vital signs such as weight, blood pressure, heart rate, oxygen level, and temperature. The system is fully integrated with the ThingSpeak IoT cloud platform. The collected data in ThingSpeak is processed by a machine learning model in the cloud to detect sudden changes in vital signs and send alerts to notify doctors. The proposed method utilizes K-means clustering to identify abnormal or sudden variations in vital signs. Future developments aim to integrate the chair with a user-friendly application that includes patient details, a video call appointment option, medication and appointment reminders, and outpatient ID (OP ID) generation.

Clinical Utility of Zuranolone for Postpartum Depression: A Narrative Review.

Peripartum depression (PPD) affects approximately one in every eight birthing individuals. Despite a high prevalence, PPD is underdiagnosed and undertreated. Several PPD treatment options exist including psychotherapies, conventional serotonergic-based antidepressants and alternative and integrative medicine approaches. Rapid-acting neuroactive steroid-based antidepressants have been studied and approved in the United States (US) for the treatment of adult females with PPD. Zuranolone is the first US Food and Drug Administration approved oral antidepressant for adult females with PPD. This narrative review reports on the evidence for the clinical utility of zuranolone in PPD treatment. In double-blind, randomized, placebo-controlled, clinical trials, zuranolone demonstrated rapid, statistically significant and clinically meaningful improvements in depressive symptoms. Most common adverse events reported with zuranolone use were somnolence, dizziness, sedation, and headache. No clinically significant changes in vital signs, electrocardiogram or clinical lab parameters were observed. No loss of consciousness and no increase in suicidal ideation from baseline or deaths were seen in the studies. Secondary analyses demonstrated that zuranolone improves comorbid symptoms of anxiety and insomnia and some measures of health-related quality of life. Zuranolone relevant infant dose lactation data suggest that its use is compatible with breastfeeding, though future research is needed to measure potential adverse effects on the breastfed infant. Key aspects of clinical decision-making in patients with PPD are discussed.

Continuous vital sign monitoring of patients recovering from surgery on general wards: a narrative review.

Most postoperative deaths occur on general wards, often linked to complications associated with untreated changes in vital signs. Monitoring in these units is typically intermittent checks each shift or maximally every 4-6 h, which misses prolonged periods of subtle changes in physiology that can herald a critical downstream event. Continuous monitoring of vital signs is therefore intuitively necessary for patient safety. The past five decades have seen monitoring systems evolve rapidly, and today entirely wireless, wearable, and portable continuous surveillance of vital signs is possible on general wards. Introduction of this technology has the potential to modify both the sensing (afferent) and response (efferent) limbs of monitoring, and will allow earlier detection of vital signs perturbations. But this comes with challenges, including but not limited to issues with connectivity, data handling, alarm fatigue, information overload, and lack of meaningful clinical interventions. Evidence from before and after studies and retrospective propensity-matched data suggests that continuous ward monitoring decreases the risk of intensive care unit (ICU) admissions, rapid response calls, and in some instances, mortality. This review summarises the history of general ward monitoring and describes future directions, including opportunities to implement these devices using artificial intelligence, pattern detection, and user-friendly interfaces. Pragmatic, well designed and appropriately powered trials, and real-world implementation data are necessary to make continuous monitoring standard practice at every hospital bed.

High-flow nasal cannula oxygen therapy versus conventional oxygen therapy in patients undergoing bronchoscopy: a retrospective study

BackgroundPatients undergoing bronchoscopy, particularly those with pre-existing hypoxemia, face a significant risk of further deterioration in their oxygen saturation levels. This heightened risk necessitates the provision of supplemental oxygen therapy throughout the procedure, rendering it mandatory. High-flow nasal cannula (HFNC) has been widely employed in the management of hypoxemic acute respiratory failure (ARF) in adults. Based on this, HFNC has been used in endoscopic procedures, but there are still few studies on HFNC in fiberoptic bronchoscopy (FOB) patients. The purpose of this study was to evaluate the comparative efficacy of HFNC with nasal cannula oxygen in maintaining adequate oxygen saturation during fiberoptic bronchoscopy in patients with pre-existing hypoxemia.MethodsWe retrospectively investigated 232 patients with hypoxemia who underwent bronchoscopy between January 2018 to August 2023 who received either HFNC or nasal cannula oxygen supplementation. The control group received nasal cannula oxygen, and the observation group received HFNC. The changes of oxygen saturation, heart rate, blood pressure and adverse events during the operation were compared between the two groups.ResultsThe patients were divided into the HFNC (n = 78) and nasal cannula oxygen (n = 154) groups. During FOB, although the lowest oxygen saturation (SpO2) was similar in both groups (intraoperative minimum SpO2 was defined as the lowest value of SpO2 occurring between the start of anesthesia and the end of the operation), the occurrence of the lowest SpO2 < 90% was significantly lower in the HFNC group (3.8% vs. 17.5%, p = 0.003). No serious complications were reported in either group, however, the overall incidence of general adverse events was 7.7% and 20.1% in the HFNC and conventional oxygen therapy (COT) groups, respectively (p = 0.015). Multifactorial analysis showed that higher arterial partial pressure of oxygen versus the fraction of inspired oxygen (PaO2/FiO2; P/F) was a protective factor against desaturation events (p = 0.032, OR = 0.990, 95% CI: 0.982–0.999). In patients with baseline PaO2/FiO2 ≥ 200 mmHg, the HFNC group exhibited smoother vital sign changes from pre-procedure to the end of bronchoscopy, although there were no significant differences between the two groups regarding the rates of deoxygenation events as well as adverse events.ConclusionThe use of HFNC therapy can effectively reduce the incidence of SpO2 < 90% during bronchoscopy in patients with hypoxemia. Additionally, HFNC significantly reduces the overall incidence of adverse events compared to COT. In patients with milder hypoxemia, its advantages in maintaining operational stability during bronchoscopy should not be overlooked.

A Novel Injectable Polypeptide Nanoparticle Encapsulated siRNA Targeting TGF-β1 and COX-2 for Localized Fat Reduction II: Phase I Clinical Trial.

Rising demand for non-invasive body contouring is driven by aesthetics and the obesity epidemic. Deoxycholic acid (DCA) is the only FDA-approved injectable for fat reduction but can cause side effects and significant local skin reactions (LSR). RNA interference, using small interfering RNA (siRNA) molecules, offers targeted fat reduction by silencing genes involved in fat maintenance. STP705, a siRNA injectable targeting TGF-β1 and COX-2, has shown promising preclinical results both invitro and in animal models. To evaluate the safety and tolerability of STP705 for localized fat reduction in subjects undergoing abdominoplasty. This phase I dose-ranging, randomized, vehicle-controlled trial involved eight females undergoing abdominoplasty who received subcutaneous STP705 injections at varying concentrations and volumes in designated abdominal zones. Safety assessments, including physical exams, lab tests, ECGs, and local skin reactions (LSRs), were conducted at baseline and follow-ups. Histopathologic evaluations of biopsies collected during abdominoplasty assessed adipocyte apoptosis and tissue remodeling. STP705 demonstrated a favorable safety profile with no clinically significant changes in lab values, vital signs, or ECGs. Adverse events (AEs) were rare and transient. The incidence, intensity, and duration of LSRs were low throughout the study. Histological analysis revealed adipocyte destruction, fat remodeling, and necrosis. STP705 was safe and very well-tolerated and showed preliminary efficacy in inducing adipocyte apoptosis and tissue remodeling, suggesting a safer alternative or adjunct to existing fat reduction therapies. These findings support further trials to establish the safety and efficacy of STP705 for targeted fat reduction and body contouring. ClinicalTrials.gov identifier: NCT05422378.

Randomized, Double-Blind, Placebo-Controlled Trial on the Efficacy, Safety and Tolerability of Modified-Release Methylphenidate (MPH-MR) in Chinese Children and Adolescents with Attention-Deficit/Hyperactivity Disorder (ADHD).

The efficacy and safety of modified-release methylphenidate (MPH-MR) in the treatment of attention-deficit/hyperactivity disorder (ADHD) have been shown in both pediatric and adult Caucasian patients. The objective of this study was to assess the efficacy and safety of MPH-MR in Chinese children and adolescents with ADHD. MICCA was a randomized, double-blind, placebo-controlled trial conducted at 19 sites in China from September 2018 to July 2021. The study enrolled children and adolescents aged 6 to <18 years with a primary diagnosis of ADHD according to the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition (DSM-5). Patients were randomized 1:1 to once-daily MPH-MR (10-60 mg) or placebo. The study included an up-titration phase of up to 5 weeks and a dose maintenance phase of 4 weeks. The primary efficacy endpoint was the change in the ADHD Rating Scale-IV (ADHD-RS-IV) total score from baseline to the end of the maintenance phase (EoM). Secondary endpoints included the change from baseline to EoM in Weiss Functional Impairment Rating Scale-Parent Report (WFIRS-P) total score, and Clinical Global Impression-Improvement (CGI-I) scores at EoM. Safety assessments included treatment-emergent adverse events (TEAEs) and vital signs. A total of 221 patients were randomized (MPH-MR: n = 110; placebo: n = 111). The change in the ADHD-RS-IV total score from baseline to EoM was significantly greater for MPH-MR versus placebo, with a least squares (LS) mean (95% confidence interval [CI]) treatment difference of -4.6 (-6.92, -2.30) (p < 0.001). The mean (95% CI) treatment difference for the WFIRS-P total score change from baseline to EoM also significantly favored MPH-MR over placebo (-6.46 [-10.57, -2.34]; p = 0.002). The CGI-I score at EoM was significantly lower in the MPH-MR group compared to the placebo group (2.2 vs 2.5; p = 0.002). Treatment-emergent adverse events were reported for 74 (67.3%) patients in the MPH-MR group and 55 (49.1%) patients in the placebo group. Most TEAEs were mild to moderate in severity. The most common TEAEs for MPH-MR were decreased appetite, nausea and upper respiratory tract infection. Treatment-emergent adverse events leading to study drug discontinuation/study withdrawal were reported in 4 (3.6%) patients in the MPH-MR group and 1 (0.9%) patient in the placebo group. No clinically relevant changes in vital signs were observed during the study. Modified-release methylphenidate was superior to placebo in improving ADHD symptoms and functioning in Chinese pediatric patients with ADHD. Modified-release methylphenidate had a good safety and tolerability profile. Trial Registration http://www.chinadrugtrials.org.cn/ Identifier: CTR20180056 (registered on 21 May 2018).

Safety observations in neuroblastoma patients undergoing 18 F- m FBG PET.

Limited safety data have been published on fluorine-18 ( 18 F) meta-fluorobenzylguanidine ( m FBG), a new PET radiopharmaceutical for imaging neural crest and neuroendocrine tumors. As part of a prospective clinical trial, safety data in patients with neuroblastoma were collected and analyzed. Between April 2015 and January 2022, 27 patients with neuroblastoma underwent 18 F- m FBG PET imaging as part of an ongoing single-center phase 1/2 trial (NCT02348749). Pre- and postinjection safety assessments were performed, including vital sign measurement and observation for occurrence of adverse events (AEs). m FBG administration resulted in no significant changes in measured vital signs. Two subjects had transient, grade 1 facial flushing shortly after the administration, which resolved within a few minutes. Neither subject had a clinically significant change in pulse or blood pressure on postadministration measurements. In this investigation of the potential clinical utility of m FBG PET imaging, no significant adverse safety signals were noted. Two mild, self-limited AEs were observed, without associated changes in vital signs. No grade 2 or higher AEs were noted. The findings are consistent with a favorable safety profile for m FBG in the target population of patients with neuroblastoma.

The clinical value of ultrasound-guided sacral anesthesia in Intracavitary and/or interstitial brachytherapy for cervical Cancer

ObjectiveTo explore the effectiveness and safety of ultrasound-guided sacral anesthesia in intracavitary and/or interstitial brachytherapy for cervical cancer patients. MethodA retrospective analysis was conducted on a total of 1039 intracavitary and/or interstitial brachytherapy involving 220 patients in our department from December 7, 2020 to March 21, 2024. The study assessed the satisfaction with anesthesia, changes in vital signs, onset time of anesthesia, dosage of anesthetic drugs, duration of anesthesia, and incidence of adverse reactions. ResultThe rate of satisfaction with anesthesia was 73.8 %. There were no significant differences in patients' heart rate (HR), mean arterial pressure (MAP), systolic blood pressure (SBP), or oxygen saturation (SaO2) before and after anesthesia (P > 0.05). The onset time of anesthesia ranged from 20 to 35 min, the average dosage of anesthetic was 20 ml, and the duration of anesthesia lasted from 30 to 120 min. Serious adverse reactions included 2 cases of post-anesthesia syncope (associated with sacral cysts). The incidence of nausea was 2.2 %, and the total incidence of other adverse reactions, such as vomiting, urinary retention, bradycardia, anal discomfort, and dizziness, was less than 1 %. ConclusionUltrasound guided sacral anesthesia demonstrates significant advantages, including effective anesthesia, minimal impact on vital signs, rapid onset, prolonged maintenance, and a low incidence of adverse reactions. It is recommended for widespread application in intracavitary and/or interstitial brachytherapy for cervical cancer patients.