Prospective Observational Study Research Articles

Impact of severe intra-abdominal adhesions on early maternal complications following cesarean delivery.

The rising rates of cesarean delivery (CD), which are a leading cause of intra-abdominal adhesions, represent a major concern for maternal health. We aimed to describe early maternal complications following CD in women with severe intra-abdominal adhesions. A prospective observational study was conducted at a university-affiliated tertiary medical center (January 2021 and March 2023) in Israel. Women who underwent CD were assessed for intra-abdominal adhesions by questionnaires completed by the surgeons. Adhesions were evaluated at four anatomical sites: abdomen-to-uterus, uterus-to-bladder, skin-to-fascia, and other intra-abdominal sites. Each site was scored on a scale of 0-2, with a total score ranging from 0 to 8. Severe adhesions were defined as a total score ≥5. The primary outcome measures were a composite complication which included at least one or more of postoperative need for blood or iron products, fever, prolonged hospitalization, re-hospitalization, and emergency room visits. Overall, 2797 women were included in the study, of whom 295 (10.6%) exhibited severe adhesions. Women with severe adhesions had a higher composite risk for maternal complications following CD (RR = 1.28, 95% confidence interval [CI]: 1.12-1.45, P < 0.001), specifically, postoperative need for blood or iron products (RR = 1.71, 95% CI: 1.15-2.55, P = 0.007) and prolonged hospitalization (RR = 1.49, 95% CI: 1.10-2.03, P = 0.009). There were no significant group differences in the rates of postoperative fever, re-hospitalization or emergency room visits. In multivariate analysis, severe adhesions had an independent impact on maternal complications (CI: 1.06-1.95, P value 0.017). Severe intra-abdominal adhesions diagnosed in CD had an impact on early maternal complications.

The response to pericapsular soft tissue and pelvic realignment therapy may be partially predicted by the relevant factors influencing the program's response of the candidates with hip osteoarthritis for joint replacement.

To explore the risk factors for discontinuation of pericapsular soft tissue and pelvic realignment (PSTP-R) therapy derived from Shiatsu in the candidates with osteoarthritis for total hip replacement (THR) (i.e., candidates for total hip replacement) treated from 2017 to 2020, and to identify the effect modifiers of PSTP-R therapy for patients who continued therapy for 6 months. Exploratory analyses of data from the clinical trial for PSTP-R therapy in a prospective observational study in which the PSTR exercises for 6 months improved Harris Hip Score (HHS) in 193 patients with an HHS below 60 points in two study centers, even in 130 patients with complete loss of cartilage on radiography among those 193 ones. The risk factors for the discontinuation of PSTP-R therapy and the effect modifiers for PSTP-R therapy were explored statistically. The risk of discontinuation of PSTP-R therapy increased as the frequency of buttock pain at baseline increased, and was mitigated as the baseline opening angle of the hip according to the modified Patrick's test increased. Cartilage loss on radiography was not a risk factor for withdrawal from PSPT-R therapy. Among patients who continued PSTP-R therapy for 6 months, a lower Kellgren-Lawrence grade at baseline was associated with an increase in the total score of HHS. Buttock pain at baseline was most associated with discontinuation of PSPT-R therapy. The patients that can improve with PSPT-R therapy should be selected to avoid inappropriate surgery by the detailed analysis of relevant clinical factors influencing the response for this program as well as image findings such as cartilage loss on radiography at baseline. Registered in the Clinical Trials Registry on 20th July 2017 (UMIN000028277).

Real-time ultrasound-guided thoracic epidural placement: Illustrating the techniques and reporting on prospective observational study.

This study aimed to assess the feasibility of real-time ultrasound-guided thoracic epidural placement. A prospective observational study was conducted in 20 patients undergoing elective abdominal and thoracic surgery. The procedure, performed with patients in a lateral position, involved three sequential steps: (1) identification of the interlaminar gap, (2) advancement of the Touhy needle, and (3) identification of the epidural space. Success was defined as the catheter insertion with achieving sensory blockade. The estimated and actual epidural depth, thoracic epidural placement success rate and procedural time were recorded. The average age and body mass index were 62.1 ± 8.9 years and 22.4 ± 4.4 kg/m2. Thoracic epidural placement was successful in 18 patients (90%, 95% confidence interval: 77-100), and at first attempt in 12 of those (66.7%). The thoracic epidural placement times and total procedural time were 5 (4-6.75) min and 19.5 ± 5.4 min, respectively. The correlation between ultrasound-estimated epidural depth and actual depth was 0.81. Ultrasound guidance enhances thoracic epidural success rates and reduces attempts and skin punctures.

Blood pressure control with active ultrafiltration measures and without antihypertensives is essential for survival in hemodiafiltration and hemodialysis programs for patients with CKD: a prospective observational study

BackgroundHigh blood pressure is a prevalent condition in patients with chronic kidney disease on hemodialysis. Adequate control of high blood pressure is essential to reducing deaths in this group. The present study aimed to observe mortality prospectively in a group of patients in hemodialysis and hemodiafiltration programs in whom the use of antihypertensives was optimized with the point-of-care dry weight (POC-DW) technique.MethodsThe present observational, prospective study was carried out at the Pafram hemodiafiltration unit in Morona Santiago, Ecuador, and the hemodialysis unit of the Fundación Renal del Ecuador in Guayaquil, Ecuador, from August 2019 to December 2023. Patients who were receiving hemodiafiltration were included. Weight was optimized with POC-DW for eight weeks. In Group 1, patients whose use of antihypertensive drugs was not required to control systolic blood pressure with a value less than 150 mmHg predialysis, less than 130 mmHg postdialysis, and a peridialytic blood pressure (defined as post-HD minus pre-HD SBP) between 0 and − 20 mmHg were analyzed. In Group 2, patients who required antihypertensive drugs for not meeting the aims of systolic blood pressure were included. The variables included clinical, demographic, mortality, description of the treatment, and routine laboratory tests in dialysis programs. The sample was nonprobabilistic. Survival analysis was performed for the study groups. The log-rank test (Mantel-Cox) was used for survival comparisons.ResultsThe study included 106 patients. Optimal blood pressure control without antihypertensive treatment was achieved in 52 patients (49.1%) (Group 1). In 54 patients (50.9%), antihypertensive agents were required (Group 2). There was more significant mortality in the group that received antihypertensives: 11 patients in group 1 (21.2%) versus 25 patients in group 2 (46.3%) (P = 0.005). Survival was more significant in group 1, with an HR of 2.2163 (1.125–4.158) (P = 0.0243).ConclusionIn hemodiafiltration and hemodialysis programs, blood pressure control with active ultrafiltration measures and without using antihypertensives is essential for survival in patients with CKD.

Construct validity, responsiveness, and interpretability of the Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI)

Objective We investigated the construct validity, responsiveness, and interpretability of the Spinal Cord Injury Functional Ambulation Inventory (SCI-FAI) to determine its usefulness in measuring the functional level of gait. Patients and Methods This was a prospective observational study following the checklist of the Consensus-Based Standards for Selecting Health Measurement Instruments. The SCI-FAI consists of three items: Gait Parameter, Assistive Devices, and Temporal. We recruited 55 patients diagnosed with a spinal cord injury (SCI) in the subacute or chronic phase from Ibaraki Prefectural University of Health Sciences Hospital. Construct validity was clarified by hypothesis testing and the rate of hypothesis verification. We divided responsiveness into subacute and chronic groups and determined the correlation between the changes in the two timepoints of the SCI-FAI and 6-minute walk test. Interpretability involved the calculation of cutoff values for indoor and outdoor walking. Results Construct validity was confirmed for 12 of the 15 hypotheses, indicating high construct validity. In the subacute group, Gait Parameter and Assistive Devices showed moderate responsiveness. Interpretability showed that the Gait Parameter was perfect in 19 of the 20 subjects who did not need a walking aid when walking. The cutoff value for Gait Parameter for indoor walking was 17.5 points (AUC 0.91) and that for Assistive Devices was 9.5 points (AUC 0.88). The cutoff values for outdoor walking were Gait Parameter 18.5 points (AUC 0.96) and Assistive Devices 10.5 points (AUC 0.94). Conclusion Our results demonstrated that the SCI-FAI has adequate construct validity, moderate responsiveness in SCI patients in the subacute phase, and interpretability in the gait assessment of individuals with SCIs. Gait Parameter is likely to show a ceiling effect for people with SCIs who can walk without using an upper-limb walking aid.

Incidence of hospital-acquired infections due to carbapenem-resistant Enterobacterales and Pseudomonas aeruginosa in critically ill patients in Italy: a multicentre prospective cohort study

BackgroundCarbapenem-Resistant Gram-Negative Bacteria, including Carbapenem-Resistant Enterobacterales (CRE) and Carbapenem-Resistant Pseudomonas aeruginosa (CRPA), are common causes of infections in intensive care units (ICUs) in Italy.ObjectiveThis prospective observational study evaluated the epidemiology, management, microbiological characterization, and outcomes of hospital-acquired CRE or CRPA infections treated in selected ICUs in Italy.MethodsThe study included patients with hospital-acquired infections due to CRE and CRPA treated in 20 ICUs from June 2021 to February 2023. The primary endpoint was the 1-year incidence of CRE/CRPA infections. Secondary endpoints included the rate of CRE/CRPA infections, mortality in ICU, infection outcome, and microbiological characterization.ResultsAmong 13,088 patients admitted over the 12-month study period across each of the 20 ICUs, 283 had CRE infections, and 138 had CRPA infections. The incidence of CRE and CRPA infections was 3.57 per 1000 patient days and 1.74 per 1000 patient days, respectively. The proportion of CRE and CRPA infections over the total number of infections due to Enterobacterales and Pseudomonas aeruginosa was 19.2% and 26.8%, respectively. Among 158 patients included in the full analysis, 98 (62%) had CRE infections and 60 (38%) had CRPA infections. Ventilator-associated pneumonia and bloodstream infections were the most common infections, occurring in 53.8 and 34.2% of cases. Empirical therapy targeting gram-negative pathogens resulted inappropriate in 59.2% of analysed patients (77/130). The overall crude mortality in ICU rate was 30.4%, with a higher rate in CRE patients (36.7%) than in CRPA patients (20.0%). Clinical success, including microbiological eradication, was achieved in 50.6% of cases. Klebsiella pneumoniae was observed as the predominant CRE species, and all CRE isolates, including metallo-β-lactamases-producing CRE (MBL-CRE), were susceptible to Aztreonam-Avibactam.ConclusionsThese results highlight the high prevalence of CRE/CRPA infections in Italian ICUs and emphasize the need for enhanced prevention and surveillance strategies.

Implementation of the enhanced adult DIVA score in an emergency department: A prospective observational study.

Short peripheral catheter (SPC) placement is a routine invasive procedure in clinical settings that is crucial for administering fluids, medications, or blood components. Approximately 11% of adult patients arriving at the Emergency Department (ED) experience difficulties with intravenous access (DIVA), necessitating advanced techniques for successful placement. The Enhanced Adult DIVA (EA-DIVA) score serves as a validated tool to promptly identify patients with DIVA. This study aimed to determine the prevalence of DIVA in the ED by using the EA-DIVA scale, evaluate the time required for venous cannulation in patients with and without DIVA, and establish EA-DIVA score thresholds for the adoption of ultrasound-guided techniques. This prospective observational study was conducted from May 2023 to January 2024 at the ED of Empoli Hospital, Italy. This study focused on adult patients requiring SPC placement. The nursing staff at the ED performed SPC placements using standard techniques according to clinical protocols. Among 1280 patients, 29.22% required more than one attempt at cannulation independently from their EA-DIVA score, with 12.58% scoring an EA-DIVA of 8 or higher. The time and attempts needed for successful cannulation increased with higher EA-DIVA scores, and ultrasound-guided techniques were more time-consuming but beneficial for these patients. An optimal threshold of 6 on the EA-DIVA scale balanced high sensitivity (96.52%) and specificity (81.37%) for identifying patients who would benefit from ultrasound guidance, minimizing failed attempts and optimizing resource use. The EA-DIVA scale, originally validated in a preoperative setting, was effectively implemented for the first time in the ED. This study established a lower cutoff score for expert intervention utilizing ultrasound guidance compared with previous applications of the EA-DIVA scale. Further validation across diverse clinical settings and among healthcare providers with varying expertise in vascular access is necessary to confirm these findings and broaden their applicability.

Reference Ranges for Cerebral Oxygenation in Neonates During Immediate Transition After Birth: Differences Between Devices.

The aim was to define reference ranges for cerebral oxygen saturation (crSO2-ROOT) during immediate transition after birth in stable neonates. In a prospective observational study, the crSO2-ROOT was continuously measured in neonates during the first 15 min after birth. The neonatal sensor was placed on the head and fixed with a bandage. Median values and 10th and 90th centiles were calculated for each minute. Additionally, cerebral fractional tissue oxygen extraction (cFTOE-ROOT) was calculated using crSO2-ROOT and arterial oxygen saturation (SpO2) measured with pulse oximetry. These crSO-ROOT values were compared with already published reference ranges of cerebral oxygen saturation measured using different devices: crSO2-INVOS and cTOI-NIRO. The data of 122 neonates (14 preterm/108 term neonates) were analysed. The crSO2-ROOT values had a similar course when compared to cTOI-NIRO values, whereas crSO2-INVOS values were initially lower and exceeded during the first minutes after birth. The present observational study added reference ranges of crSO2-ROOT in stable neonates immediately after birth. As there are differences regarding reference ranges of various near-infrared spectroscopy (NIRS) devices, it is important to be aware of this information for future clinical use.

Comparison of Inter-Incisor Distance as a Predictor of Difficult Intubation in Men and Women-A Prospective Observational Study.

Most of the studies on difficult intubation and laryngoscopy focused on American and European populations. However, Indians have distinct anthropometric characteristics compared to these populations. This study aims to determine the gender difference in inter-incisor distance (IID) cut-off marks to assess the ease of intubation in the Indian population. A prospective observational study was conducted on 516 patients scheduled for elective surgery under general anesthesia with endotracheal intubation. Preoperative assessments included IID, thyromental distance, neck circumference, sternomental distance (SMD), thyrohyoid distance, mentohyoid distance, and modified mallampatti grading. Intubation difficulty scores (IDSs) were assessed during intubation. The optimal cut-off values of inter incisor gap and difficult intubation were analyzed by receiver operating characteristic curve analysis. The total cohort was grouped into males (Group 1 [n = 258]) and females (Group 2 [n = 258]). Males had a significantly higher mean age (P = 0.04) and weight (P = 0.00) than females. Difficult intubation incidence was 16.3% of males and 6.2% of females. Increased IID (P = 0.039), decreased SMD (P = 0.046), and males (P = 0.002) are identified as predictors of difficult intubation.IID and IDS showed greater specificity than sensitivity, with significant cut-off values of 4.25 and 1.50, respectively. The cut-off value of IID did not show a significant difference in gender variation. Despite the low IID in females, intubation difficulties were not observed compared to males.

Neutrophil-to-Lymphocyte Ratio (NLR) and Mean Platelet Volume (MPV) to Platelet Count Ratio in the Prognosis of Neonatal and Pediatric Sepsis.

To calculate and assess the role of neutrophil-to-lymphocyte ratio (NLR) and mean platelet volume (MPV)/ platelet count (PLT) ratios and their trends as prognostic indicators in neonates and children with sepsis. This prospective observational study was planned over a period of two years at a tertiary care teaching hospital. Two hundred seventy children with clinical suspicion of or diagnosed as sepsis were enrolled. Serial hemograms (day 1, 4, 7, 10) and trends of NLR and MPV/PLT ratios were reviewed. NLR on day 10 of hospital stay had maximum sensitivity of 65% and specificity of 62%. Day 1 MPV was significantly higher in the mortality group. There was a significant correlation between lower Pediatric Sequential Organ Failure Assessment (p-SOFA) score and MPV in the survival group. MPV/PLT ratio on day 7 had maximum sensitivity of 85% and specificity of 74% in prediction of mortality. Serial decreasing trend of NLR (2.88-1.16) and MPV/PLT from day 1 to 10 (8.58-8.48) were associated with improved outcome (p < 0.001). High NLR, MPV and MPV/PLT on admission are associated with increased mortality in neonatal and pediatric sepsis. Serial decreasing trends in NLR, MPV and MPV/PLT ratio are associated with improved prognosis.

Impact of clear aligners on gingivitis incidence and prevention strategies in adolescents and adults: a prospective observational study

ObjectiveThis study aims to analyze the differences in gingivitis incidence among adolescents and adults using clear aligners for orthodontic correction and to evaluate the effectiveness of prevention strategies on orthodontic outcomes.MethodsThis observational study included 120 patients undergoing clear aligner orthodontic treatment from June 2018 to September 2023. Participants were divided into an adolescent group (66 cases) and an adult group (54 cases), each further split into a study group and a control group. The control group patients maintained their daily lifestyle throughout the study period. The study group received personalized oral hygiene education and guidance on self-oral care techniques at each follow-up visit. Routine periodontal treatment and personalized oral hygiene education were provided, and the incidence of gingivitis was evaluated six months post-treatment. Statistical methods, including chi-square tests for categorical data, t-tests for continuous variables, and two-way ANOVA for group comparisons, were employed to ensure the robustness of the results.ResultsThe incidence of gingivitis was significantly higher in the adolescent group compared to the adult group (P < 0.05). Specifically, within the adolescent group, the study group exhibited a higher gingival index (GI) than the control group (P < 0.05), while the difference in the adult group was not significant.ConclusionDuring clear aligner orthodontic treatment, adolescents are more prone to developing gingivitis than adults. Additionally, basic periodontal therapy, as opposed to verbal oral health education alone, can moderately reduce the incidence of gingivitis in clear aligner patients during treatment.

Cardiopulmonary exercise testing as a prognosis-assessing tool in heart failure with preserved ejection fraction.

Patients with heart failure with preserved ejection fraction represent half of the heart failure patients nowadays, an at least steady trend due to the aging of the population. We investigated whether the parameters obtained from cardiopulmonary exercise testing (CPET) correlated with the prognosis of these patients. This prospective observational cohort study assesses the relationship between the CPET parameters peakVO2 and VE/VCO2 slope and the number of heart failure hospitalizations or cardiovascular death of these patients. From August 2016 until May 2019, 99 patients from our outpatient unit with newly diagnosed heart failure with preserved ejection fraction underwent CPET. Median follow-up was 30months [interquartile range, 24-38.5]. We selected peakVO2<14mL/min/kg and a VE/VCO2 slope>34 as threshold values for our primary clinically relevant endpoint, a composite of hospitalization for heart failure or cardiovascular death. Mean age was 75.07±7.31years, 49% were women, 75% were at NYHA class II and median NTproBNP was 511pg/mL. Mean peakVO2 was 15.09±4.75, and mean VE/VCO2 was 36.05±6.60. During follow-up, there were 207 all-cause hospitalizations, 126 cardiovascular hospitalizations, 58 heart failure hospitalizations and 4 deaths. Over a median follow-up of 30months, the primary clinically relevant endpoint occurred in 5 of 40 patients (12.5%) with a VE/VCO2 slope≤34 and in 19 of 59 patients (32.2%) with a VE/VCO2 slope>34 [hazard ratio, 2.69; 95% confidence interval (CI), 1.00-7.21; P=0.04]. On multivariate analysis, VE/VCO2 slope was independently associated with heart failure hospitalization or cardiovascular death as a terminal event. In patients with heart failure with preserved ejection fraction, a VE/VCO2 slope>34 predicts heart failure hospitalizations and cardiovascular death.

Simultaneous Measurement of Calciprotein Particles with Different Assays and Clinical Outcomes in CKD

Background: Mineral metabolism abnormalities are an almost universal feature of chronic kidney disease (CKD) and are thought to contribute to the development of many adverse events. Calciprotein particles (CPP) form spontaneously in biological fluids from calcium and phosphate together with the glycoprotein fetuin-A. While CPP formation is a part of normal mineral homeostasis, levels are chronically elevated in CKD. Several assays have been developed to measure serum CPP, each linking high CPP levels to adverse clinical outcomes in CKD. However, direct comparisons among these assays are lacking. This exploratory study aims to compare these assays to assess their association with CKD progression and mortality. Methods: We measured baseline CPP levels using various methods on stored serum samples from 189 participants in a prospective observational cohort study of CKD stage 3/4 patients. Three assays were used to measure CPP: (1) ELISA (Fetuin-A CPP), (2) low-density (L-CPP) and high-density CPP (H-CPP) via gel filtration, and (3) primary (CPP-I) and secondary CPP (CPP-II) via flow cytometry. We examined the association of each CPP measure with all-cause mortality and CKD progression using unadjusted and covariate-adjusted Cox proportional hazard regression models. Results: In fully adjusted models, H-CPP (hazard ratio [HR] 1.53, 95% confidence interval [CI] 1.05 – 2.23, p=0.028) and CPP-II (HR 3.11, 95% CI 1.97 – 4.98, p&lt;0.001) were significantly associated with an increased risk of all-cause mortality. Additionally, L-CPP (HR 1.91, 95% CI 1.43 – 2.62, p&lt;0.001), CPP-I (HR 1.31, 95% CI 1.04 – 1.65, p=0.023), and CPP-II (HR 1.66, 95% CI 1.20 – 2.29, p=0.002) were significantly associated with CKD progression. Conclusions: In a cohort of individuals with CKD stages 3 and 4, serum CPP-II levels demonstrated the strongest association with all-cause mortality, while L-CPP levels showed the strongest association with CKD progression.

Clinical presentation, acute care management and discharge information of patients with thoracic trauma in South Africa and Sweden: a prospective multicenter observational study

PurposeThoracic trauma causes pain and hospitalisation. Middle- and high-income countries have different trauma contexts and populations. To report patients’ clinical presentation (pain and shortness of breath) and its influence on hospital length of stay (LOS), acute care management, and discharge destinations in South Africa (SA) and Sweden.MethodsProspective observational multicenter study by means of clinical record review. Two centers in SA and four centers in Sweden participated. One thousand nine hundred and eighteen adults with thoracic trauma were screened over the 20 months period. Study objectives guided information retrieved from clinical records. Statistical analysis was done with significance at p-value < 0.05.ResultsThree-hundred-sixty-four participants were recruited with most being male (n = 170/179 (95%) SA; n = 125/185 (68%) Sweden). Type and mechanism of injury differed (SA penetrating (82%) versus Sweden blunt (95%); SA assaults (90%) versus Sweden falls (44%)). Unilateral haemopneumothorax was common (SA 68%, Sweden 35%) and managed with intercostal drainage. Rib cage injuries were common in the Swedish cohort with rib fixation surgery for 17%. Physiotherapy treatment frequency was mostly daily. Blunt injury resulted in higher pain levels during deep breathing (day 1: p = 0.014; day 2: p < 0.001; day 3: p < 0.001) and shortness of breath during activity (day 1: p = 0.036; day 2: p = 0.003; day 3: p < 0.001). LOS was shorter for SA cohort (5 (± 4) versus 7 (± 5) days; p = 0.024). Age influenced LOS in the blunt injury group. Discharge destination was mostly home (99% SA, 56% Sweden).ConclusionPriority care is indicated for those who are older and have blunt thoracic injury to prevent pulmonary complications and prolonged hospitalisation.

Longitudinal Recovery Trajectories and Ventilatory Modalities in Covid-19 ARDS Survivors

IntroductionThe impact of the different ventilatory support modalities and the timing of intubation on longitudinal lung recovery trajectories in patients with severe COVID-19 is unknown.MethodsA multicenter, prospective observational study conducted in 52 Spanish intensive care units (ICUs) involving critically ill COVID-19 patients admitted between February 25th, 2020, to February 28th, 2021. 1854 COVID-19 patients were followed after hospital discharge at 3, 6 and 12 months with lung diffusing capacity (DLCO) and a chest imaging. Patients were classified regarding the ventilatory support received during the ICU stay: noninvasive mechanical ventilation (NIMV), high-flow nasal cannula (HFNC) and invasive mechanical ventilation (IMV) divided into early IMV (intubation &lt;24 h) and late IMV (intubation &gt;24 h). The primary objective is to evaluate the impact of the different respiratory support modalities during the ICU stay and time of intubation on DLCOmeasurements and their recovery trajectories over a one-year follow-up. Secondary outcomes include other pulmonary function parameters and chest imaging findings.ResultsA total of 360 (19.4%) and 290 (15.6%) patients received HFNC and NIMV, respectively. 1204 (64.9%) patients underwent IMV; 966 received early IMV and 238 late IMV. The latter exhibited a significantly worse percentage of predicted DLCOduring the one-year follow-up with adjusted differences (95%CI; p-value) of 6.9 (3.9 to 10; p&lt;0.001), 4.2 (1.1 to 7.2; p=0.007) and 4.9 (1.7 to 8.2; p=0.003) at 3, 6 and 12 months compared with early IMV. NIMV patients exhibited greater lung damage at follow-up than those under HFNC with an adjusted difference of DLCOvalues of 5.2 (1.7 to 8.7; p=0.003) at 6 months and greater presence of radiological abnormalities during the follow-up. Matched and sensitivity analysis showed results consistent with those reported.ConclusionsDelay in intubation implies the worst outcomes; however, patients with NIMV exhibited a slower lung recovery in terms of DLCOmeasurements and more radiological abnormalities compared with HFNC patients. These results should be used to optimize follow-up protocols for COVID-19 ARDS survivors. These findings may serve as a valuable consideration for optimizing follow-up protocols for survivors of COVID-19 ARDS.

Role of procalcitonin, C reactive protein and ferritin in cytokine release syndrome after CAR T-cell therapy in children and young adults

ABSTRACT Purpose Chimeric antigen receptor (CAR) T-cell CD19 therapy has changed the treatment paradigm for patients with relapsed/refractory B-cell acute lymphoblastic leukemia. It is frequently associated with potentially severe toxicities: cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and admission to PICU is often required. Some biomarkers seem to correlate with CRS severity. Our goal is to elucidate the role of procalcitonin (PCT), C-reactive protein (CRP) and ferritin in the context of CRS following CAR T-cell infusion to predict its severity and PICU admission. Methods Prospective observational study (2016-2022) in children and young adult who received CAR T-cell therapy (Tisagenlecleucel/ARI-0001). We collected epidemiologic data, specific CAR T-cell toxicities, PICU admission, biomarker results (procalcitonin, CRP and ferritin), length of stay and mortality. Biomarkers were analyzed considering two values: the highest value during ward admission, and the highest overall value including PICU admission. Results Seventy-seven patients were included. Median age at infusion was 9.1 years (IQR 6-13), 49.4% were females. Before CAR T-cell infusion, the median bone marrow blast was 9% (IQR 0-59). The most frequent toxicity was CRS in 62 patients (80.5%), it was severe in 18 cases (23.4%). Fourteen patients (18.1%) had ICANS. Thirty-one patients (40.3%) required admission to the PICU. PCT and ferritin were higher in patients admitted to PICU (PCT 0.8 ng/ml vs 0.15 ng/ml, p < 0.001, ferritin 5490 vs. 2900 ug/l, p < 0.019). The proposed cut-off for PCT to predict admission to PICU is 0.55 ng/mL, presenting a sensitivity of 67.7% and a specificity of 86.7%. The maximum value of the three biomarkers was higher in those who presented any primary outcome: development of a severe CRS, the need for admission to PICU, and in-hospital mortality. Biomarkers were higher in those who needed inotropic or respiratory support. Conclusions PCT levels increase after CAR-T cell therapy in the setting of systemic inflammation and could be a predictor of PICU admission and evolution to death. Further research studying its role in the context of CRS and the differential diagnosis between infection and CRS is needed to better understand the biology of this biomarker and to define its value in clinical practice.

Energy availability and macronutrient intake over a 7-day training period in adolescent rugby players.

Understanding the dietary intake of elite adolescent athletes and its adequacy with sport nutrition recommendation is a key issue for health and player development, as well as performance and recovery. Energy availability needs to be considered to ensure optimal health and performance in young athletes. The present study aimed to quantify energy availability, energy expenditure and macronutrient intake in young male rugby union players competing at national level. Twelve male adolescent players (15.6±0.6 years) completed a 7-days prospective observational study (5 days of training and 2 days of full recovery). Total energy expenditure was estimated using indirect calorimetry and heart rate measurement. Energy intake was assessed using weighed food by a dietitian in cafeteria (training days) and image-based dietary (recovery days). Energy availability was calculated using (energy intake-exercise energy expenditure)/fat-free mass. Mean energy availability was 38.5±7.5, 40.2±5.4 and 47.8±5.1 kcal/kgFFM/d on heavy training, moderate training and recovery days, respectively. Players consumed a low carbohydrate (~5.0 g/kg/d), high protein (~2.0 g/kg/d) and high fat (~1.8 g/kg/d) diet on training and recovery days in relation to current international nutritional recommendations for young athletes. Athletes showed sub-optimal energy availability on training days, high energy availability on recovery days and did not comply with carbohydrate intake recommendations on training nor recovery days. These results highlight the short-term inadequacy of energy availability as a result of low carbohydrate intake, warning about the possible adverse short-term metabolic effects on health and performance of young athletes.

Incidence and risk of infections in patients with ankylosing spondylitis receiving biologic therapies: A prospective observational study using the KOBIO registry.

This study aimed to assess infection occurrence of infection and risk factors among ankylosing spondylitis (AS) patients treated with biologics in a real-world setting. This prospective observational cohort study included AS patients from the Korean College of Rheumatology BIOlogics (KOBIO) registry who initiated or switched to biologic agent between December 2012 and July 2023. The primary outcome was the first occurrence of any infection, ranging from mild to severe, classified by organ system. The infection rate per 1,000 person-years (PY), with a 95% confidence interval were calculated using the Poisson distribution method. Cox proportional hazard regression models, adjusted for confounders, estimated hazard ratios for infection risk, considering only the first infection event. This analysis included 2,129 patients with a total of 7,107.67 PY of follow-up. The predominant infections observed were of the upper and lower respiratory tract (25.89/1000 PY), followed by herpes zoster (HZ) (6.13/1000 PY). Multivariate Cox regression analysis revealed significant risk factors for infection, including age, ischemic heart disease, complicated diabetes, chronic kidney disease (CKD), and peripheral arthritis. In contrast, male sex was identified as a protective factor against the development of infections. The infection rate was 39 events/1,000 PY with respiratory tract infections being most common, followed by HZ. Significant risk factors included age, female sex, ischemic heart disease, complicated diabetes, CKD and peripheral arthritis for the occurrence of infection in patients with AS treated with biologics.

Intralesional steroid injection in keloid ear — a prospective observational study

BackgroundKeloid is a fibro-proliferative dermal benign growth affecting the Asian population. In India, ear keloids are common, often resulting from ear piercing, a prevalent cultural practice. The resultant ear keloids pose aesthetic concerns, leading to significant psychological distress, and necessitating effective treatment. While various treatment options are available, their outcomes and recurrence rates vary, highlighting the need for individualized and optimal management strategies. Our study aimed to observe the combined effect of intralesional triamcinolone with hyaluronidase on keloid regression.MethodsThis prospective observational study was conducted at our tertiary care institute over 1 and a half years. Fifty patients who met the inclusion criteria were enrolled and received intralesional triamcinolone injection with hyaluronidase. Keloid regression was assessed using the Vancouver Scar Scale (VSS), while the visual analogue score (VAS) and patient satisfaction score (PSS) provided subjective evaluations of symptom relief. All patients underwent compression therapy. Patients were evaluated at every visit and then at 1 year for symptom relief, keloid regression, and complications if any.ResultsDemographic data of all patients were recorded. Ear keloids were predominantly observed in females, with a male-to-female ratio of 18:32. The most common etiology was trauma following ear piercing, accounting for 46% of cases. All patients showed improvement in VSS, VAS, and PSS scores in the follow-up visits. A total of 98% of patients demonstrated a complete treatment response, with only a single instance of recurrence.ConclusionIntralesional triamcinolone with hyaluronidase provides satisfactory symptomatic relief and has lower recurrence rates. All patients showed improvement in the Vancouver Scar Scale and had enhanced VAS and PSS scores.

The Role of Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Prediction of Sepsis-Associated Encephalopathy: Prospective Observational Study.

Ultrasonographic optic nerve sheath diameter (ONSD) is a satisfactory noninvasive intracranial pressure (ICP) monitoring test. Our aim was to evaluate ONSD as an objective screening tool to predict and diagnose ICP changes early in sepsis-associated encephalopathy (SAE). Our prospective observational study was conducted on patients with sepsis, and after intensive care unit (ICU) admission, the time to diagnose SAE was recorded, and patients were divided into a non-SAE group including conscious patients with sepsis and a SAE group including patients with sepsis with acute onset of disturbed conscious level. ONSD was measured within 24h of ICU admission for all patients and then every other day for up to 10 consecutive days until ICU discharge or death. The primary outcome was to compare ONSD measurements of both groups to find if there was a correlation between ONSD and SAE occurrence. Eighty-nine patients with sepsis were divided into a non-SAE group (n = 45) and an SAE group (n = 44). ONSD showed a statistically significant difference at day 0 and a highly significant difference at days 2, 4, 6, 8, and 10. Day 2 ONSD had the best accuracy for predicting SAE, with a cutoff > 5.2mm (sensitivity of 93.2%, specificity of 100%), a statistically positive correlation with the Sequential Organ Failure Assessment score (r = 0.485, P < 0.001) and ICU length of stay (r = 0.238, P < 0.001), and a statistically significant wider in patients who died compared to those who survived (P < 0.001). ONSD could be an objective screening method for early diagnosis of SAE, with a cutoff > 5.2mm. Trial registration NCT05849831 ( https://clinicaltrials.gov/study/NCT05849831 ).