Prospective Observational Pilot Study Research Articles

FAPi PET/CT for assessment and visualisation of active myositis-related interstitial lung disease: a prospective observational pilot study

Interstitial lung disease (ILD) is a common manifestation of idiopathic inflammatory myopathies (IIM) and a substantial contributor to hospitalisation, increased morbidity, and mortality. In-vivo evidence of ongoing tissue remodelling in IIM-ILD is scarce. We aimed to evaluate fibroblast activation in lungs of IIM-patients and control individuals using ⁶⁸Ga-labelled inhibitor of Fibroblast-Activation-Protein (FAPi) based positronic emission tomography and computed tomography imaging (PET/CT). In this prospective observational pilot study, consecutive patients with IIM and participants without rheumatic conditions or ILD serving as a control group were recruited at the Medical University of Vienna, Austria, and underwent FAPi PET/CT imaging. Standard-of-care procedures including clinical examination, assessment of severity of dyspnoea, high-resolution computed tomography (HR-CT), and pulmonary function testing (PFT) were performed on all patients with IIM at baseline and for patients with IIM-ILD at follow-up of 12 months. Baseline pulmonary FAPi-uptake was assessed by the maximum (SUVmax) and mean (SUVmean) standardized uptake values (SUV) over the whole lung (wl). SUV was corrected for blood pool background activity and target-to-background ratios (TBR) were calculated. We compared pulmonary FAPi-uptake between patients with IIM-ILD and those without ILD, as well as controls, and correlated baseline FAP-uptake with standard diagnostic tools such as HR-CT and PFT. For predictive implications, we investigated whether patients with IIM and progressive ILD exhibited higher baseline FAPi-uptake compared to those with stable ILD. Metrics are reported as mean with standard deviation (±SD). Between November 16, 2021 and October 10, 2022, a total of 32 patients were enrolled in the study. Three participants from the control group were excluded due to cardiopulmonary disease. In individuals with IIM-ILD (n=14), wlTBRmax and wlTBRmean were significantly increased as compared with both non-ILD-IIM patients (n=5) and the control group (n=16): wlTBRmax: 2.06±1.04 vs. 1.04±0.22 (p=0.019) and 1.08±0.19 (p=0.0012) and wlTBRmean: 0.45±0.19 vs. 0.26±0.06 (p=0.025) and 0.27±0.07 (p=0.0024). Similar values were observed in wlTBRmax or wlTBRmean between non-ILD IIM patients and the control group. Patients with progressive ILD displayed significantly enhanced wlTBRmax and wlTBRmean values at baseline compared to patients with stable ILD: wlTBRmax: 1.30±0.31 vs. 2.63±1.04 (p=0.0084) and wlTBRmean: 0.32±0.08 vs. 0.55±0.19 (p=0.021). Strong correlations were found between FAPi-uptake and disease extent on HR-CT (wlTBRmax: R=0.42, p=0.07; wlTBRmean: R=0.56, p=0.013) and severity of respiratory symptoms determined by the New York Heart Association (NYHA) classification tool (wlTBRmax: R=0.52, p=0.022; wlTBRmean: R=0.59, p=0.0073). Further, pulmonary FAPi-uptake showed inverse correlation with forced vital capacity (FVC) (wlTBRmax: R=-0.56, p=0.012; wlTBRmean: R=-0.64, p=0.0033) and diffusing capacity of the lungs for carbon monoxide (DLCO) (wlTBRmax: R=-0.52, p=0.028; wlTBRmean: R=-0.68, p=0.0017). Our study demonstrates higher fibroblast activation in patients with IIM-ILD compared to non-ILD patients and controls. Intensity of pulmonary FAPi accumulation was associated with progression of ILD. Considering that this study was carried out on a small population, FAPi PET/CT may serve as a useful non-invasive tool for risk stratification of lung disease in IIM. The Austrian Research Fund.

Accuracy of orthodontic movements with 3D printed aligners: A prospective observational pilot study.

Owing to the availability of 3D software, scanners, and printers, clinicians are encouraged to produce in-office aligners. Recently, a new directprinting resin (Tera Harz TC-85DAC) has been introduced. Studies on its mechanical characteristics and biological effects have been published; however, evidence on its efficacy in orthodontic treatment remains scarce. This pilot study aimed to investigate the accuracy of teeth movement achieved with directprinted aligners. Seventeen patients (eight males and nine females) with a mean age of 27.67 ± 8.95 years, presenting with dental rotations < 30° and spaces/crowding < 5 mm, were recruited for this study. The teeth movement was planned starting from a T0 digital dental cast. The 3D direct-printed aligners were produced using Tera Harz TC-85DAC resin. Once the orthodontic treatment was completed, a final digital cast was obtained (T1). The planned teeth positions were then superimposed onto the T0 and T1 digital models. The differences between the programmed movements and the achieved overall torque, tip, rotation, and transverse dimensions were assessed using the paired t test or Wilcoxon's signed rank test. The overall accuracies for torque, tip, and rotation were 67.6%, 64.2%, and 72.0%, respectively. The accuracy of the change in transverse diameter was 99.6%. Within the limits of the present pilot study (difficulties with abnormally shaped teeth and use of attachments), it can be concluded that 3D printed aligners can be successfully printed in-house and utilized for mildly crowded cases, with a comparable accuracy of tooth movement to that of other aligners.

#1820 Use of MiDiálisis App in peritoneal dialysis patients

Abstract Background and Aims Technological innovation has revolutionized medical assistance. Peritoneal dialysis (PD) patients, who prioritize their autonomy and freedom choosing to undergo dialysis at home, are the paradigm of patients willing to use telemedicine. Remote monitoring allows real-time therapy supervision, ensures proper adherence and empowers the patients by promoting self-care and self-awareness The aim of this study is to assess the feasibility and acceptance of MiDiálisis App. Method MiDiálisis App, developed independently, integrates essential self-care data (such as blood pressure, ultrafiltration and weight), presenting it in real-time graphs and tables for both patients and nephrologists. It also allows asynchronous communication between them. This is a prospective observational pilot study in which MiDiálisis App was offered to PD patients at a tertiary hospital. Results Out of the 10 patients offered the use of the MiDiálisis App, 3 did not use it (NU) due to technical issues. Seven patients used (U) MiDiálisis for a median of 9 [4-11] months. The majority were male (n = 6) and on automated PD (n = 6) for a period of 30 (15-38) months. We registered 6.3 (5.6-6.7) days with interaction/week. NU patients were older (U 61 [54-69] years vs NU 68 [34-75] years, p = 0.5), with higher comorbidity Charlson index (U 5 [4-7] points vs NU 7 [3-9] points, p = 0.5), and greater Frail index (U 2 [1-2] points vs NU 3 [2-4] points, p = 0.067). Six patients completed a survey after using MiDiálisis. 100% perceived a better communication with their nephrologist and greater accuracy of data compared to their previous method (paper-based recording). All of them entered the data by themselves and found both learning and using MiDiálisis to be easy; 83% considered the app beneficial for their health, and 100% felt secure using it. Furthermore, 67% reported significant changes in their self-care habits, and 83% mentioned an increased awareness of their health status. All participants would recommend it to other patients. Conclusion MiDiálisis App is applicable and has good acceptance among people undergoing PD. It might be a useful tool that can improve self-care, adherence, and communication with these patients.

#1651 Urinary oxygen partial pressure: closely associated with hourly urine output induced by furosemide in patients with acute renal injury

Abstract Background and Aims Urine oxygen level, an indicator of kidney medullar oxygenation, is promising for predicting the onset of acute kidney injury (AKI). Furosemide, a commonly used diuretic in ICU, significantly increases urine output and is believed to change kidney medullar oxygenation. We monitored the longitudinal change of urinary oxygen partial pressure during bolus or pump administration of furosemide, aiming to describe the reaction pattern in an AKI-susceptible patient population. Method The prospective observational pilot study included seven adult patients in the ICU because of cardiac surgery or sepsis. We monitored the continuous urinary oxygen partial pressure for 8-24 hours through a device placed between the urinary catheter and collecting bag during furosemide administration, recorded hourly urine output simultaneously from a urine bag, and followed the patients in the hospital for the onset and development of AKI. Results We recruited three female patients and four male patients with an average age of 54 years and a medium of 5 days in ICU with an AKIN stage I of AKI during their hospital stay. None of them developed more severe stage AKI or required any kidney replacement therapy. We found a reverse correlation pattern between hourly urine output and urinary oxygen partial pressure. Specifically, the urine oxygen level dropped during urine volume increase caused by furosemide bolus administration and abolished by furosemide administration through a pump with more stable urine output. The paired t-test showed a significant increase in average urine oxygen level (mean difference = 21.2 mmHg, p = 0.044) recorded during the “high hourly urine output” period compared to the “low hourly urine period”. Conclusion We first found a drop in urinary oxygen partial pressure during the high urine output period elicited by bolus furosemide administration. It shed light on the confounding factors in AKI predicating during possible furosemide administration.

Lung Ultrasound to Evaluate Fluid Status and Optimize Early Volume-Expansion Therapy in Children with Shiga Toxin-Producing Escherichia Coli–Haemolytic Uremic Syndrome: A Pilot Study

Background: Shiga toxin-producing Escherichia coli–haemolytic uremic syndrome (STEC-HUS) can result in kidney and neurological complications. Early volume-expansion therapy has been shown to improve outcomes, but caution is required to avoid fluid overload. Lung ultrasound scanning (LUS) can be used to detect fluid overload and may be useful in monitoring hydration therapy. Methods: This prospective observational pilot study involved children with STEC-HUS who were recruited from a regional paediatric nephrology centre. B-line quantification by LUS was used to assess fluid status at the emergency department (ED) admission and correlated with the decrease in patient weight from the target weight. A control group of children on chronic dialysis therapy with episodes of symptomatic fluid overload was also enrolled in order to establish a B-line threshold indicative of severe lung congestion. Another cohort of “healthy” children, without renal or lung-related diseases, and without clinical signs of fluid overload was also enrolled in order to establish a B-line threshold indicative of euvolemia. Results: LUS assessment was performed in 10 children with STEC-HUS at ED admission, showing an average of three B-lines (range 0–10). LUS was also performed in 53 euvolemic children admitted to the ED not showing kidney and lung disease (healthy controls), showing a median value of two B-lines (range 0–7), not significantly different from children with STEC-HUS at admission (p = 0.92). Children with STEC-HUS with neurological involvement during the acute phase and those requiring dialysis presented a significantly lower number of B-lines at admission compared to patients with a good clinical course (p &lt; 0.001). Patients with long-term renal impairment also presented a lower number of B-lines at disease onset (p = 0.03). Conclusions: LUS is a useful technique for monitoring intravenous hydration therapy in paediatric patients with STEC-HUS. A low number of B-lines at ED admission (&lt;5 B-lines) was associated with worse short-term and long-term outcomes. Further studies are needed to determine the efficacy and safety of an LUS-guided strategy for reducing complications in children with STEC-HUS.

Brain injury plasma biomarkers in patients on veno-arterial extracorporeal membrane oxygenation: A pilot prospective observational study.

Early diagnosis of acute brain injury (ABI) is critical for patients on veno-arterial extracorporeal membrane oxygenation (V-A ECMO) to guide anticoagulation strategy; however, neurological assessment in ECMO is often limited by patient sedation. In this pilot study of adults from June 2018 to May 2019, plasma samples of glial fibrillary acidic protein (GFAP), neurofilament light chain (NFL), and tubulin associated unit (Tau) were collected daily after V-A ECMO cannulation and measured using a multiplex platform. Primary outcomes were occurrence of ABI, assessed clinically, and neurologic outcome, assessed by modified Rankin Scale (mRS). Of 20 consented patients (median age = 48.5°years; 55% female), 8 (40%) had ABI and 15 (75%) had unfavorable neurologic outcome at discharge. 10 (50%) patients were centrally cannulated. Median duration on ECMO was 4.5°days (IQR: 2.5-9.5). Peak GFAP, NFL, and Tau levels were higher in patients with ABI vs. without (AUC = 0.77; 0.85; 0.57, respectively) and in patients with unfavorable vs. favorable neurologic outcomes (AUC = 0.64; 0.59; 0.73, respectively). GFAP elevated first, NFL elevated to the highest degree, and Tau showed limited change regardless of ABI. Further studies are warranted to determine how plasma biomarkers may facilitate early detection of ABIs in V-A ECMO to assist timely clinical decision-making.

The Interplay between Perioperative Oxidative Stress and Hepatic Dysfunction after Human Liver Resection: A Prospective Observational Pilot Study.

Post-hepatectomy liver failure (PHLF) remains the major contributor to death after liver resection. Oxidative stress is associated with postoperative complications, but its impact on liver function is unclear. This first in-human, prospective, single-center, observational pilot study evaluated perioperative oxidative stress and PHLF according to the ISGLS (International Study Group for Liver Surgery). Serum 8-isoprostane, 4-hydroxynonenal (4-HNE), total antioxidative capacity, vitamins A and E, and intraoperative, sequential hepatic tissue 4-HNE and UCP2 (uncoupling protein 2) immunohistochemistry (IHC) were assessed. The interaction with known risk factors for PHLF and the predictive potential of oxidative stress markers were analyzed. Overall, 52 patients were included (69.2% major liver resection). Thirteen patients (25%) experienced PHLF, a major factor for 90-day mortality (23% vs. 0%; p = 0.013). Post-resection, pro-oxidative 8-isoprostane significantly increased (p = 0.038), while 4-HNE declined immediately (p < 0.001). Antioxidative markers showed patterns of consumption starting post-resection (p < 0.001). Liver tissue oxidative stress increased stepwise from biopsies taken after laparotomy to post-resection in situ liver and resection specimens (all p < 0.001). Cholangiocarcinoma patients demonstrated significantly higher serum and tissue oxidative stress levels at various timepoints, with consistently higher preoperative values in advanced tumor stages. Combining intraoperative, post-resection 4-HNE serum levels and in situ IHC early predicted PHLF with an AUC of 0.855 (63.6% vs. 0%; p < 0.001). This was also associated with grade B/C PHLF (36.4% vs. 0%; p = 0.021) and 90-day mortality (18.2% vs. 0%; p = 0.036). In conclusion, distinct patterns of perioperative oxidative stress levels occur in patients with liver dysfunction. Combining intraoperative serum and liver tissue markers predicts subsequent PHLF. Cholangiocarcinoma patients demonstrated pronounced systemic and hepatic oxidative stress, with increasing levels in advanced tumor stages, thus representing a worthwhile target for future exploratory and therapeutic studies.

Incidence of acute kidney injury and its associated risk factors in patients undergoing elective oesophagectomy surgeries at a tertiary care cancer institute – A pilot prospective observational study

Background and Aims: Acute kidney injury (AKI) is a significant postoperative complication. Multiple perioperative factors are implicated in the causation of AKI in the postoperative period in patients with oesophageal cancer. The study aimed to find out the incidence, causes and effects of AKI following oesophagectomy surgery. Methods: A prospective observational study was conducted in consecutive adult patients undergoing elective oesophagectomy at a tertiary cancer care hospital. Patients with preoperative chronic renal insufficiency (serum creatinine &gt;1.5 mg/dl), AKI in the past and a history of renal replacement therapy were excluded. Serum creatinine values were measured on postoperative days 1, 3, 5, the day of discharge or day 15 and on the day of first follow-up or day 28, following oesophagectomy surgery. The incidence of AKI was measured using the ‘Kidney Disease Improving Global Outcome’ (KDIGO) criteria. Results: The incidence of AKI was 14.7% [95% confidence interval (CI) 9.9%, 20.7%] (i.e., 27/183) in patients who underwent elective oesophagectomy. AKI was associated with prolonged hospital stay [median- 13 days (interquartile range {IQR} 11–21.5) versus 9 days (IQR 8–12), P &lt; 0.001] and increased in-hospital mortality (14.8% versus 1.3%, P 0.004, odds ratio = 13.2, 95% CI 2.3, 77.3). After multivariate analysis, age, anastomotic leak and use of vasopressors in the postoperative period were independent predictors of AKI. Conclusion: The incidence of AKI was 14.7% after elective oesophagectomy. AKI was associated with prolonged hospital stay and in-hospital mortality. Higher age, anastomotic leak and use of vasopressors in the postoperative period were independent predictors of AKI.

Transanal eco-Doppler evaluation after hemorrhoidal artery embolization

BACKGROUND Hemorrhoidal artery embolization (Emborrhoid) is a novel method for the treatment of severe hemorrhoidal bleeding. Despite having a technical success rate of 93%-100%, the clinical success ranges between 63% and 94%, with a rebleeding rate of 13.6%. AIM To evaluate the effectiveness of this procedure in reducing hemorrhoidal flow and hemorrhoidal bleeding. METHODS This prospective observational pilot study was conducted at Division of General Surgery 1 and Tertiary Referral Pelvic Floor Center, Treviso Regional Hospital, Italy. In a 2 months period (February-March 2022), consecutive patients with hemorrhoidal bleeding scores (HBSs) ≥ 4, Goligher scores of II or III, failure of non-operative management, and a candidate for Emborrhoid were included. Endoanal ultrasound with eco-Doppler was performed preoperatively and 1 month after the procedure. The primary endpoint was to quantify the changes in arterial hemorrhoidal flow after treatment. The secondary endpoint was to evaluate the correlation between the flow changes and the HBS. RESULTS Eleven patients underwent Emborrhoid. The overall pretreatment mean systolic peak (MSP) was 14.66 cm/s. The highest MSP values were found in the anterior left lateral (17.82 cm/s at 1 o’clock and 15.88 cm/s at 3 o’clock) and in the posterior right lateral (14.62 cm/s at 7 o’clock and 16.71 cm/s at 9 o’clock) quadrants of the anal canal. After treatment, the overall MSP values were significantly reduced (P = 0.008) although the correlation between MSP and HBS changes was weak (P = 0.570). A statistical difference was found between distal embolization compared with proximal embolization (P = 0.047). However, the coil landing zone was not related to symptoms improvement (P = 1.000). A significant difference in MSP changes was also reported between patients with type 1 and type 2 superior rectal artery (SRA) anatomy (P = 0.040). No relationship between hemorrhoidal grades (P = 1.000), SRA anatomy (P = 1.000) and treatment outcomes was found. CONCLUSION The preliminary findings of this pilot study confirm that Emborrhoid was effective in reducing the arterial hemorrhoidal flow in hemorrhoidal disease. However, the correlation between the post-operative MSP and HBS changes was weak. Hemorrhoidal grade, SRA anatomy and type of embolization were not related to treatment outcomes.

Role of electrocardiometry in hemodynamic assessment of children with shock in multisystem inflammatory syndrome following COVID-19: A single-center prospective observational study

Background: The hemodynamic profile in multisystem inflammatory syndrome in children (MIS-C) has not been well described. Therefore, we conducted the study utilizing electrocardiometry (EC) to assess the hemodynamic characteristics in MIS-C patients presenting with shock. Subjects and Methods: This pilot prospective observational study was conducted in the pediatric intensive care unit of a tertiary care hospital. Children between 2 months and 18 years meeting the WHO criteria for MIS-C presenting with shock during second COVID-19 pandemic were included in the study. All patients underwent measurement of hemodynamic profile with EC for the initial 48 h of enrollment. Based on EC assessment at enrolment, the systemic vascular resistance index (SVRi) of 1000–1600 dyn s/cm5/m2 was regarded as normal. The hemodynamic categorization was defined as vasodilatory shock in EC (VDEC) (SVRi &lt;1000 dyn s/[cm5/m2]) and vasoconstrictive shock in EC (VCEC) (SVRi &gt; 1600 dyn s/[cm5/m2]). Results: Thirty-one children met the WHO case definition of MIS-C during the study period. Sixteen children with shock were enrolled and studied. Clinically, 7 (43.75%) children had cold shock, whereas 9 (56.25%) had warm shock. The measured baseline (mean [standard deviation]) hemodynamic variables were cardiac index (CI) of 6 ± 1.41 L/min/m2, stroke volume variation of 23% ±9.6%, SVRi of 954.75 ± 263.35 dyn s/(cm5/m2), and thoracic fluid content of 51.18 ± 17.26 ml. VDEC was the predominant manifestation (87.5%) based on EC. Conclusions: Vasodilatory shock was the predominant phenotype observed in critically ill children with MIS-C with shock by EC assessment.

Improving diagnostics using extended point-of-care testing during in-home assessments of older adults with signs of emerging acute disease: a prospective observational non-randomised pilot and feasibility study

BackgroundDelayed recognition of acute disease among older adults hinders timely management and increases the risk of hospital admission. Point-of-Care testing, including Focused Lung Ultrasound (FLUS) and in-home analysis of biological material, may support clinical decision-making in suspected acute respiratory disease. The aim of this study was to pilot test the study design for a planned randomised trial, investigate whether in-home extended use of point-of-care testing is feasible, and explore its’ potential clinical impact.MethodsA non-randomised pilot and feasibility study was conducted during September–November 2021 in Kolding Municipality, Denmark. A FLUS-trained physician accompanied an acute community nurse on home-visits to citizens aged 65 + y with signs of acute respiratory disease. The acute community nurses did a clinical assessment (vital signs, capillary C-reactive protein and haemoglobin) and gave a presumptive diagnosis. Subsequently, the physician performed FLUS, venipuncture with bedside analysis (electrolytes, creatinine, white blood cell differential count), nasopharyngeal swab (PCR for upper respiratory pathogens), and urine samples (flow-cytometry). Primary outcomes were feasibility of study design and extended point-of-care testing; secondary outcome was the potential clinical impact of extended point-of-care testing.ResultsOne hundred consecutive individuals were included. Average age was 81.6 (SD ± 8.4). Feasibility of study design was acceptable, FLUS 100%, blood-analyses 81%, PCR for upper respiratory pathogens 79%, and urine flow-cytometry 4%. In addition to the acute community nurse’s presumptive diagnosis, extended point-of-care testing identified 34 individuals with a condition in need of further evaluation by a physician.ConclusionOverall, in-home assessments with extended point-of-care testing are feasible and may aid to identify and handle acute diseases in older adults.

Machine Learning-Based Prediction of Changes in the Clinical Condition of Patients With Complex Chronic Diseases: 2-Phase Pilot Prospective Single-Center Observational Study.

Functional impairment is one of the most decisive prognostic factors in patients with complex chronic diseases. A more significant functional impairment indicates that the disease is progressing, which requires implementing diagnostic and therapeutic actions that stop the exacerbation of the disease. This study aimed to predict alterations in the clinical condition of patients with complex chronic diseases by predicting the Barthel Index (BI), to assess their clinical and functional status using an artificial intelligence model and data collected through an internet of things mobility device. A 2-phase pilot prospective single-center observational study was designed. During both phases, patients were recruited, and a wearable activity tracker was allocated to gather physical activity data. Patients were categorized into class A (BI≤20; total dependence), class B (20<BI≤60; severe dependence), and class C (BI>60; moderate or mild dependence, or independent). Data preprocessing and machine learning techniques were used to analyze mobility data. A decision tree was used to achieve a robust and interpretable model. To assess the quality of the predictions, several metrics including the mean absolute error, median absolute error, and root mean squared error were considered. Statistical analysis was performed using SPSS and Python for the machine learning modeling. Overall, 90 patients with complex chronic diseases were included: 50 during phase 1 (class A: n=10; class B: n=20; and class C: n=20) and 40 during phase 2 (class B: n=20 and class C: n=20). Most patients (n=85, 94%) had a caregiver. The mean value of the BI was 58.31 (SD 24.5). Concerning mobility aids, 60% (n=52) of patients required no aids, whereas the others required walkers (n=18, 20%), wheelchairs (n=15, 17%), canes (n=4, 7%), and crutches (n=1, 1%). Regarding clinical complexity, 85% (n=76) met patient with polypathology criteria with a mean of 2.7 (SD 1.25) categories, 69% (n=61) met the frailty criteria, and 21% (n=19) met the patients with complex chronic diseases criteria. The most characteristic symptoms were dyspnea (n=73, 82%), chronic pain (n=63, 70%), asthenia (n=62, 68%), and anxiety (n=41, 46%). Polypharmacy was presented in 87% (n=78) of patients. The most important variables for predicting the BI were identified as the maximum step count during evening and morning periods and the absence of a mobility device. The model exhibited consistency in the median prediction error with a median absolute error close to 5 in the training, validation, and production-like test sets. The model accuracy for identifying the BI class was 91%, 88%, and 90% in the training, validation, and test sets, respectively. Using commercially available mobility recording devices makes it possible to identify different mobility patterns and relate them to functional capacity in patients with polypathology according to the BI without using clinical parameters.

Impaired cerebral autoregulation detected in early prevasospasm period is associated with unfavorable outcome after spontaneous subarachnoid hemorrhage: an observational prospective pilot study

BackgroundSubarachnoid hemorrhage (SAH) patients with cerebral autoregulation (CA) impairment at an early post-SAH period are at high risk of unfavorable outcomes due to delayed cerebral ischemia (DCI) or other complications. Limited evidence exists for an association between early-stage CA impairments and SAH patient outcomes. The objective of this prospective study was to explore associations between CA impairments detected in early post-SAH snapshot examinations and patient outcomes.MethodsThe pilot observational study included 29 SAH patients whose CA status was estimated 2–3 days after spontaneous aneurysm rupture and a control group of 15 healthy volunteers for comparison. Inflatable leg recovery boots (reboots.com, Germany) were used for the safe controlled generation of arterial blood pressure (ABP) changes necessary for reliable CA examination. At least 5 inflation‒deflation cycles of leg recovery boots with a 2–3 min period were used during examinations. CA status was assessed according to the delay time (∆TCBFV) measured between ABP(t) and cerebral blood flow velocity (CBFV(t)) signals during artificially induced ABP changes at boot deflation cycle. CBFV was measured in middle cerebral artery by using transcranial Doppler device.ResultsStatistically significant differences in ∆TCBFV were found between SAH patients with unfavorable outcomes (∆TCBFV = 1.37 ± 1.23 s) and those with favorable outcomes (∆TCBFV = 2.86 ± 0.99 s) (p < 0.001). Early assessment of baroreflex sensitivity (BRS) during the deflation cycle showed statistically significant differences between the DCI and non-DCI patient groups (p = 0.039).ConclusionsA relatively small delay of ∆TCBFV <1.6 s between CBFV(t) and ABP(t) waves could be an early warning sign associated with unfavorable outcomes in SAH patients. The BRS during boot deflation can be used as a biomarker for the prediction of DCI.Trial registrationClinicalTrials.gov Identifier: NCT06028906. Registered 31 August 2023 - Retrospectively registered, https://www.clinicaltrials.gov/study/NCT06028906.

The effects of virtual reality interventions on occupational participation and distress from symptoms in palliative care patients: A pilot study.

Virtual reality (VR) offers the prospect of a safe and effective adjunct therapeutic modality to promote mental health and reduce distress from symptoms in palliative care patients. Common physiological and psychological symptoms experienced at the end of life may impact the person's participation in day-to-day activities that bring them meaning. The purpose of this study was to examine the effect of VR interventions on occupational participation and distress from symptoms. To describe the stimulus, results, and learnings from a single-site pilot study of virtual reality therapy in a specialist palliative care setting. Participants engaged in a VR session lasting from 9 to 30 minutes related to coping with pain, inner peace and mindfulness, adventure, and bucket list. The pilot prospective quantitative observational cohort study was conducted from November 2021 through March 2022 using a pre-post VR intervention research design. Quantitative data was collected using patient-rated assessments and a wireless pulse oximeter. Occupational performance, satisfaction, and distress symptoms were measured using the Canadian Occupational Performance Measure and the Palliative Care Outcomes Collaboration Symptom Assessment Scale (PCOC SAS). The intervention and study design adhered to international guidelines. Ten participants engaged in the VR interventions. Data showed significantly improved occupational performance and satisfaction scores (p < .001), decreases in PCOC SAS distress from pain (p = .01), fatigue (p < .001), and heart rate (p = .018). No adverse side effects were observed. Outcomes included an analysis of virtual reality's effectiveness to alleviate symptom burden and increase occupational participation for palliative care patients. Of specific interest to the research team was the application of virtual reality in a community-based and inpatient palliative care context to supplement allied health services and its feasibility of integration into standard palliative care. VR therapy showed positive improvements in the participants' occupational performance, satisfaction, and distress from pain and fatigue.

Observational pilot study of multi-wavelength wearable light dosimetry for erythropoietic protoporphyria.

Erythropoietic protoporphyria (EPP) causes painful light sensitivity, limiting quality of life. Our objective was to develop and validate a wearable light exposure device and correlate measurements with light sensitivity in EPP to predict and prevent symptoms. A wearable light dosimeter was developed to capture light doses of UVA, blue, and red wavelengths. A prospective observational pilot study was performed in which five EPP patients wore two light dosimeters for 3 weeks, one as a watch, and one as a shirt clip. Standard deviation (SD) increases from the mean in the daily blue light dose increased the odds ratio (OR) for symptom risk more than the self-reported outdoor time (OR 2.76 vs. 2.38) or other wavelengths, and a one SD increase from the mean in the daily blue light wristband device dose increased the OR for symptom risk more than the daily blue light shirt clip (OR 2.45 vs. 1.62). The area under the receiver operator curve for the blue light wristband dose was 0.78, suggesting 78% predictive accuracy. These data demonstrate that wearable blue light dosimetry worn as a wristband is a promising method for measuring light exposure and predicting and preventing symptoms in EPP.

Novel Biomarkers in Evaluating Cardiac Function in Patients on Hemodialysis-A Pilot Prospective Observational Cohort Study.

Chronic kidney disease patients treated by hemodialysis present a high cardiovascular morbidity and mortality. There is an imperative need for novel biomarkers for identifying these patients and to offer possible therapeutically interventions. We performed a prospective observational cohort study on 77 patients in the period of October 2021-October 2023. We measured serum plasma levels of interleukin 1-beta, galectin 3, human suppression of tumorigenicity factor 2, bone morphogenetic protein 2 and fibroblastic growth factor 23 at the inclusion site. We evaluated the correlations of these biomarkers with cardiac function and structure evaluated by echocardiography. The mean age was 61.02 (±11.81) years, with 45 (56.2%) males and with a dialysis vintage of 4.95 (2.4-7.8) years. Median ejection fraction was 51 (43-54%), and more than two-thirds of the patients presented valvular calcifications. Overall mortality was 22%. Interleukin 1-beta was correlated positively with ejection fraction and global longitudinal strain and negatively with left atrium diameter and left ventricle telesystolic diameter. Galectin 3 values were negatively correlated with aortic valve fibrosis and mitral valve calcifications, and human suppression tumorigenicity factor 2 was negatively correlated with mitral valve calcifications. Some of these novel biomarkers could be used to better assess cardiovascular disease in patients on maintenance hemodialysis.

Perfusion magnetic resonance imaging in Asherman syndrome.

Microvascular scarring compromises the functionality of the endometrium, and vascular flow at the junctional zone (JZ) may be the key to understanding poor reproductive outcomes in women with Asherman syndrome (AS). To investigate whether vascular perfusion of the uterus, measured by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is impaired in women with intrauterine adhesions (IUA) and AS. A prospective observational cohort pilot study of 23 women with IUA treated with hysteroscopic synecholysis and a control group of two patients with cervix cancer were subject to DCE-MRI with gadolinium to assess uterine vascularity. Twelve regions of interest (ROIs) were allocated on the DCE-MRI image incorporating the JZ, with control ROI placed at the psoas muscle. Individual ROIs were compared to the mean total perfusion (TP) in the same uterus. Pre- and post-operative perfusion analyses were performed on five women. Receiver operator curves (ROC) were used to analyse MRI as a predictor of IUA. There was no significant difference in perfusion; a trend toward reduced perfusion was observed in women with IUA compared to the controls. The ROC was predictive of higher-grade and inoperable IUA. Reduced perfusion on DCE-MRI as assessed by ROC predicted higher-stage AS. The results of this study support further investigation of DCE-MRI as a prognostic tool for AS prior to surgical intervention to assist in providing prognostic guidance for women suffering from AS.

Sleep Disturbances as a Consequence of Long COVID-19: Insights from Actigraphy and Clinimetric Examinations—An Uncontrolled Prospective Observational Pilot Study

The COVID-19 pandemic represents a global health and social challenge. However, the impact of a SARS-CoV-2 infection itself on mental health and sleep quality remains poorly understood. The purpose of the present uncontrolled prospective observational pilot study was to evaluate the impact of past COVID-19 disease on the incidence of quantitative and qualitative sleep disturbances. A group of 61 subjects (37 female, 24 male) reported sleep disturbances that had lasted for at least one month and had started after recovery from COVID-19. The study used self-reported instruments: the Epworth Sleepiness Scale (ESS) and Insomnia Severity Index (ISI), as well as an objective method—actigraphy—for quantitative analysis of sleep architecture. It was shown that sleep disturbances most commonly started after recovery (68.3%, n = 41) and lasted for more than one month (83.6%, n = 51). ESS scores of 7.8 ± 5.0 points indicate moderate daytime sleepiness, and ISI scores of 16.3 ± 5.8 points denote moderate insomnia. ESS scores were negatively correlated with total time in bed (r = −0.3780, p = 0.003), total sleep time (r = −0.2969, p = 0.020), and wakefulness after sleep onset (r = −0.2654, p = 0.039). In addition, ESS scores were correlated negatively with the respondents’ age (B = −0.17, p = 0.000) and time from COVID-19 onset. A positive correlation was found between wakefulness after sleep onset and ESS scores (B = −0.05, p = 0.039). ISI scores were positively correlated with time in bed (r = 0.3275, p = 0.010). Female gender was found to be a significant predictor of insomnia’s severity (B = 2.159, t = 3.04, p = 0.004). In conclusion, patients with a history of COVID-19 report long-lasting sleep disturbances that do not subside spontaneously. In the patient group studied, moderate levels of daytime sleepiness and insomnia were found. The most frequently reported problems included irregular sleep, frequent awakenings, and difficulty maintaining sleep, while normal sleep duration was preserved. These findings underscore the need for continued attention to the long-term consequences of COVID-19 on sleep health and emphasize the importance of targeted interventions to address these enduring sleep disturbances in affected individuals.

P184 Challenging Barriers in Inflammatory Bowel Disease: First Observational Analysis of Double Biological Therapy in Mexico

Abstract Background Inflammatory bowel disease is a chronic inflammation of the GI tract, despite advances in treatment with biologic therapy, some patients may develop an inadequate response, known as refractory IBD (rIBD).Given this reality, the approach of double biological therapy (DBT) has emerged to effectively address and improve control of inflammation, providing them with an additional therapeutic option Methods Pilot prospective observational study evaluateing response to DBT in patients with refractory IBD Results A total of 7 patients with rIBD who received DBT were included, the average age was 29 ± 9, all female. The average duration of illness before starting dual therapy was 8 ± 2years. Patients had received an average of 2 previous biological treatments, 4 (57%) had a history of surgery related to IBD, 5 (71%) and 2(29%) had a history of stenosis and fistulas respectively and 100% used steroids and immunomodulators before starting DBT. Four DBT combinations were evaluated: CERTOLIZUMAB+VEDOLIZUMAB (group 1), USTEKINUMAB+VEDOLIZUMAB (group 2), INFLIXIMAB+USTEKINUMAB (group 3) and INFLIXIMAB+VEDOLIZUMAB (group 4).Group 1 included 1 patient with improvement in clinical activity, with a decrease in endoscopic activity from i4 to i2 by Rutgeerts criteria and Nancy index 1.Group 2 included 4 patients showed improvement in clinical and endoscopic activity, there was a reduction in clinical activity by CDAI from 225 to 66, and improvement in endoscopic activity from L1 B2 to L1 B1, i0 L2 B3P to i0 L1 B1 and i3 L3 B2 to i2 L3 B1 with different activity rates, Nancy's histology that varied from 0 to 3.Group 3 included 1 patient showed a reduction in clinical activity by CDAI from 210 to 166, endoscopic activity also decreased from i0 L2B3P to i0 L1 B1 with Nancy index of 2.Group 4 includes 1 with a decrease in clinical activity by Truelove-Witts from 2 to 2, endoscopic activity also decreased from 8 to 5 accordingto UCEIS with Nancy index of 1.In all groups, a reduction in the use of steroids was observed and no cases of infections associated with dual biological therapy were reported Conclusion This prospective observational pilot study represents the first analysis in Mexico and, to our knowledge, in Latin America, on the use of DBT in patients with rIBD who showed clinical, endoscopic and histopathological improvement in the majority of cases. It is important to recognize the limitations of this study, such as its pilot design and sample size. This pioneering study in refractory IBD presents encouraging results that suggest clinical and endoscopic benefits in the treated patients. These results justify the conduct of larger studies to strengthen the evidence and provide a solid basis for thepotential use of this therapy in clinical practice

Simultaneous Venous-Arterial Doppler Ultrasound During Early Fluid Resuscitation to Characterize a Novel Doppler Starling Curve: A Prospective Observational Pilot Study.

Background: The likelihood of a patient being preload responsive-a state where the cardiac output or stroke volume (SV) increases significantly in response to preload-depends on both cardiac filling and function. This relationship is described by the canonical Frank-Starling curve. Research Question: We hypothesize that a novel method for phenotyping hypoperfused patients (ie, the "Doppler Starling curve") using synchronously measured jugular venous Doppler as a marker of central venous pressure (CVP) and corrected flow time of the carotid artery (ccFT) as a surrogate for SV will refine the pretest probability of preload responsiveness/unresponsiveness. Study Design and Methods: We retrospectively analyzed a prospectively collected convenience sample of hypoperfused adult emergency department (ED) patients. Doppler measurements were obtained before and during a preload challenge using a wireless, wearable Doppler ultrasound system. Based on internal jugular and carotid artery Doppler surrogates of CVP and SV, respectively, we placed hemodynamic assessments into quadrants (Qx) prior to preload augmentation: low CVP with normal SV (Q1), high CVP and normal SV (Q2), low CVP and low SV (Q3) and high CVP and low SV (Q4). The proportion of preload responsive and unresponsive assessments in each quadrant was calculated based on the maximal change in ccFT (ccFTΔ) during either a passive leg raise or rapid fluid challenge. Results: We analyzed 41 patients (68 hemodynamic assessments) between February and April 2021. The prevalence of each phenotype was: 15 (22%) in Q1, 8 (12%) in Q2, 39 (57%) in Q3, and 6 (9%) in Q4. Preload unresponsiveness rates were: Q1, 20%; Q2, 50%; Q3, 33%, and Q4, 67%. Interpretation: Even fluid naïve ED patients with sonographic estimates of low CVP have high rates of fluid unresponsiveness, making dynamic testing valuable to prevent ineffective IVF administration.