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☐ ☆ ✇ BMJ Open

Careful ventilation in acute respiratory distress syndrome: the protocol of the CAVIARDS international multicentre randomised basket trial

Por: Coudroy · R. · Telias · I. · Jonkman · A. · Thille · A. W. · Diehl · J.-L. · Peron · N. · Ko · M. · Bourion · A.-A. · Tiribelli · N. · Fredes · S. · Gutierrez · M. · Manchado Bruno · A. · Vasquez · D. N. · Pratto · R. A. · Plotnikow · G. A. · Bianchini · F. · Accoce · M. · Dorado · J. · Sp — Febrero 23rd 2026 at 12:58
Introduction

Acute respiratory distress syndrome (ARDS) is a major public health problem, accounting for 23% of intubated patients and associated with high mortality rates. Although lifesaving, invasive mechanical ventilation can worsen lung injury when ventilator settings are poorly adjusted to lung physiology. We hypothesise that individualising ventilator settings via (1) the bedside assessment of lung recruitability using a one-breath derecruitment manoeuvre and measurement of airway opening pressure to set positive end-expiratory pressure (PEEP), (2) controlling the distending pressure and (3) controlling respiratory drive improves ARDS outcomes.

Methods and analysis

The CAreful Ventilation In ARDS trial is an investigator-led multicentre (33 centres in eight countries), open-label, randomised controlled basket trial comparing two ventilation strategies in two subpopulations of moderate-to-severe ARDS: induced or not by COVID-19. A total of 740 patients will be randomised (370 in each substudy) in a 1:1 ratio to individualised ventilator settings or to using traditional PEEP to inspired fraction of oxygen tables for PEEP setting. Indications for proning and weaning strategies are similar in both arms. The primary outcome is all-cause mortality at day 60. Secondary outcomes include duration of mechanical ventilation, duration of intensive care unit (ICU) and hospital stay, organ dysfunction, barotrauma and mortality in ICU, at day 28 and in hospital.

Ethics and dissemination

Ethics approval has been obtained for all participating centres: Unity Health Toronto Research Ethics Board (for three centres: St Michael’s Hospital, Toronto General Hospital and Toronto Western Hospital); Comité de Ética de Investigación con Medicamentos del Hospital Universitari Vall d’Hebron; Comité de protection des personnes Ile de France III; Comité d'Ética de la Investigatción con Medicamentos de la Fundació de Gestió Sanitària del Hospital de la Santa Creu i Sant Pau; Comitato Etico—Fondazione Policlinico Gemelli; Comitato Etico di Area Vasta Emilia Centro; NYU Langone Health Institutional Review Board; Comité Ético Científico de Ciencias de la Salud; Il Comitato Etico Area 1 dell’Azienda Ospedaliero-Universitaria ‘Ospedali Riuniti’ di Foggia; HIGA ‘Eva Perón’ Comité de Bioética; Comité de Revisión Institucional del Hospital Británico Comité de Ética en Investigación; Complejo Médico Churruca-Visca Comité de Ética Biomédica; Comité de Ética SATI Comité de Ética en Investigación; Comité de Ética en Investigación del CEMIC; Comité de Ética SATI Comité de Ética en Investigación; Medical Research Ethics Committees United. Findings will be disseminated in peer review journals and conference presentations.

Trial registration number

NCT03963622.

☐ ☆ ✇ PLOS ONE Medicine&Health

Investigating the effects of cannabinoids for the reduction of inflammation and sickle cell disease pain (CRISP); A protocol for a randomized double-blind placebo-controlled study

by Jordan Bellis, Lydia Monk, Ritika Jhawar, Galia Pollock, Angela Liu, Charleen Jacobs-McFarlane, Brittany McCrary, Jeffrey Glassberg, Susanna Curtis

Sickle Cell Disease (SCD) is a hemoglobinopathy affecting millions of people globally. Pain, both acute and chronic, affects over half of those living with SCD, but treatment of chronic pain is an ongoing challenge. While opioid treatments are widely used for chronic pain, it’s efficacy is limited, so alternatives must be explored. This protocol outlines a procedure for investigation of dronabinol, an FDA-approved synthetic tetrahydrocannabinol (THC), for the treatment of pain in patients living with SCD and chronic pain. The study is an 8-week, randomized, double-blind placebo-controlled study which aims to assess both the efficacy and safety of this opioid alternative to pain treatment. The study will also track biomarkers of inflammation as THC has demonstrated anti-inflammatory properties, and inflammation is a driver of SCD pain and disease severity. Results from this study have the potential to further clinical understanding of cannabinoids for pain management in Sickle Cell Disease treatment and spark new questions for research.
☐ ☆ ✇ PLOS ONE Medicine&Health

Faster but less accurate: An explorative study on the effects of three weeks of ketogenic diet on cognitive functions in undergraduate students

by Gianluigi Serio, Consiglia Pacelli, Claudia Piccoli, Nazzareno Capitanio, Giuseppe Cibelli, Anna Antonia Valenzano, Francesca Landini, Leonardo Carlucci, Paola Palladino

The ketogenic diet (KD) is a low-carbohydrate diet that induces and sustains a ketosis state and minimizes somatic glucose levels. Several psychological studies have described the positive effects of ketosis on cognitive functions for a wide range of neuropsychiatric conditions (e.g., Alzheimer’s disease; epilepsy), leading to greater interest in the KD today. However, the psychological and cognitive effects of inducing ketosis via diet remain unclear, especially in healthy people. From an initial pool of thirty participants, eight undergraduate students performed a cognitive assessment before (baseline) and after three weeks (follow-up) of an isocaloric ketogenic diet. Several neuropsychological measures and psychometric tests have been administered to investigate psychological chronotype, sleep quality, eating habits, anxiety and cognitive components of attention, inhibition, and memory. Non-parametric Bayesian analysis showed that the ketogenic diet affected cognitive functions. Participants performed cognitive tests faster at follow-up than at baseline, showing improvements in visual-motor cognitive and processing speed components. However, they were less accurate on working memory tasks, suggesting a decreasing performance of higher cognitive functions. Finally, no differences in anxiety levels were found between baseline and follow-up. The results could have significant implications for identifying specific cognitive models of students based on specific lifestyle habits and nutritional patterns, allowing the implementation of targeted interventions to improve university learning conditions.
☐ ☆ ✇ PLOS ONE Medicine&Health

Identifying risk patterns for sudden cardiac death in athletes: A clustering and principal component analysis approach

by Giacinto Angelo Sgarro, Paride Vasco, Domenico Santoro, Luca Grilli, Marco Giglio, Natale Daniele Brunetti, Luigi Traetta, Giuseppe Cibelli, Anna Antonia Valenzano

Sudden Cardiac Death (SCD) is a critical and unexpected condition that occurs due to cardiac causes within one hour of the onset of acute cardiovascular symptoms or twenty-four hours in unwitnessed cases. Despite advancements in cardiovascular medicine, practical methods for predicting SCD are still lacking, and there are no standardized systems to identify individuals at risk, especially in seemingly healthy populations such as athletes. In this study, we employed hierarchical clustering and principal component analysis (PCA) on data from 711 competitive athletes, revealing distinct patterns and cluster distributions in PCA space. Specifically, Clustering revealed characteristic feature combinations associated with increased SCD risk in athletes. Notably, certain clusters shared traits, including participation in Class C sports, sinus tachycardia, ventricular pre-excitation, personal or family history of heart disease, T-wave inversions, and prolonged QTc intervals. PCA helped visualize these patterns in distinct spatial regions, highlighting underlying structures and aiding intuitive risk interpretation. These results enable scientists to derive cluster metrics that serve as reference points for classifying new individuals and visually representing risk patterns in a clear graphical format. These findings establish a foundation for predictive tools that, with additional clinical validation, could aid in the prevention of SCD. The dataset used in this study, along with the clustering and PCA results, is available to the scientific community in an open format, together with the necessary tools and scripts to enable independent experimentation and further analysis.
☐ ☆ ✇ BMJ Open

Examining the role of staff and team communication in reducing seclusion, restraint and forced tranquilisation in acute inpatient mental health settings: protocol for the Communication and Restraint Reduction (CaRR) study

Por: Cibelli · F. · Forbes · T. · McCabe · R. · Anderson · J. E. · Hoe · J. · Tahir · S. · McKeown · G. J. · Brew · B. · Deamer · F. · Lavelle · M. — Noviembre 6th 2025 at 06:00
Introduction

Over 100 000 service users are admitted to acute mental health wards annually, many involuntarily. Wards are under incredible pressure due to high bed occupancy rates and staff shortages. In a recent survey, over 80% of mental health nurses reported experiencing aggression and violence within their role. National and international policy dictates that mental health ward staff manage incidents of aggression and violence using communication, known as de-escalation. However, de-escalation practice is variable, and there is little empirical evidence to underpin training. As such, there is still a reliance on more restrictive practices, including seclusion and physical restraint.

Aim

The aim of this study is to identify the communication and organisational factors that characterise effective management of service users’ behaviour and distress in acute adult inpatient mental health wards, reducing the reliance on more restrictive practices (eg, seclusion and restraint).

Methods and analysis

This observational study will be conducted on mental health wards in England. It will be comprised of three work packages (WPs).

  • A microanalysis of communication during de-escalation incidents from Body Worn Camera footage on wards (n=64), to identify staff communication practices that lead to effective management of service users’ distress.

  • Ethnographic observations of ward routine practice, alongside interviews and questionnaires with staff and service users, to examine how challenging behaviour is anticipated, planned for and responded to on wards, and staff experiences and perceptions of this process.

  • Triangulation of the findings from WPs 1 and 2 to examine the relationship between approaches to aggression management and staff communication, exploring the similarities and differences within and between wards.

  • Ethics and dissemination

    Ethical approval for sites in England has been granted by the Wales Research Ethics Committee 3, REF 22/WA/0066. Findings will be disseminated through peer-reviewed journals, scientific conferences and service user and clinical networks.

    ☐ ☆ ✇ BMJ Open

    Use of an innovative electronic communications platform (912Rwanda) to improve prehospital transport of injured people in Rwanda: protocol for a type 2 hybrid effectiveness-implementation interrupted time series study

    Por: Rwanda912 RIGHT Group · Quinn · Assuman · Nishimwe · Sheferaw · Alayande · Munyura · Bagahirwa · Hagenimana · Ignatowicz · D'Ambruoso · Muhire · Jayaraman · Belli · Bojke · Rickard · Ajisola · Hemming · Byiringiro · Davies — Agosto 14th 2025 at 04:49
    Introduction

    Injury is a major cause of death in Rwanda, with many deaths occurring before hospital admission. Timely transport of injured patients to appropriate hospitals is crucial, ideally within an hour for severely injured patients. However, delays in reaching treatment facilities are common, with ambulance services using inefficient mobile phone communication. This project aims to evaluate the effectiveness and implementation of an innovative electronic communication platform (912Rwanda).

    Methods and analysis

    The study will be conducted through the public ambulance service, Service d’Aide Médicale d’Urgence (SAMU), and receiving health facilities in Kigali city and Musanze district in Rwanda. The 912Rwanda intervention will be rolled out in the two locations at different times. The primary effectiveness outcome is the time from ambulance deployment to patient arrival at the health facility. Secondary effectiveness outcomes include disaggregated times of the primary outcome and clinical outcomes, such as length of stay and requirement for intensive care. These outcomes will be evaluated using an interrupted time series analysis, accounting for non-homogeneous variances, auto-regressive errors and non-linear trends where appropriate. Implementation outcomes will be evaluated using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) Qualitative Evaluation for Systematic Translation (QuEST) framework. Cost-effectiveness will be evaluated using a cost-consequence analysis with consequences as determined by the interrupted time series analysis.

    Ethics and dissemination

    Ethical approval was obtained from the Rwanda National Research Ethics Committee (Ref No: 99/RNEC/2023). Dissemination will occur through open-access peer-reviewed publications, relevant national and international conferences.

    Trial registration number

    ISRCTN97674565.

    ☐ ☆ ✇ BMJ Open

    Comparative relationships between physical and verbal abuse of children, life course mental well-being and trends in exposure: a multi-study secondary analysis of cross-sectional surveys in England and Wales

    Por: Bellis · M. A. · Hughes · K. · Ford · K. · Quigg · Z. · Butler · N. · Wilson · C. — Agosto 6th 2025 at 00:30
    Objectives

    To test associations between mental well-being across the life course and exposure to childhood physical and/or verbal abuse.

    Design

    Secondary analysis of combined data from seven cross-sectional general adult population surveys measuring childhood experience of physical and/or verbal abuse and current mental well-being.

    Setting

    Households across England and Wales.

    Participants

    20 687 residents in England and Wales aged 18 years or over.

    Measures

    Self-reported childhood physical and verbal abuse using questions from an Adverse Childhood Experiences tool. Individual and combined components of adult mental well-being measured using the short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS).

    Results

    Exposure to either childhood physical abuse or verbal abuse was associated independently with a similar significant increase in likelihood of low adult mental well-being, with exposure to both abuse types compounding increases (adjusted ORs 1.52, 1.64, 2.15 respectively, reference category: neither abuse type). Individual components of mental well-being showed similar associations, with adjusted prevalence of never or rarely having felt close to people in the last 2 weeks rising from 7.7% (neither abuse type) to 9.9% (physical abuse), 13.6% (verbal abuse) and 18.2% (both types of abuse). Within sample trends showed a significant drop in the prevalence of child physical abuse from around 20% in those born from 1950 to 1979 to 10% in those born in 2000 or after. However, verbal abuse rose from 11.9% in those born before 1950 to nearly 20% in those born in 2000 or after.

    Conclusion

    Exposure to childhood physical or verbal abuse have similar associations with lower mental well-being during adulthood. Interventions to reduce child abuse, including physical chastisement, should consider both physical and verbal abuse and their individual and combined consequences to life course health. The potential role of childhood verbal abuse in escalating levels of poor mental health among younger age groups needs greater consideration.

    ☐ ☆ ✇ NURE Investigación

    Epidemiologia y factores pronósticos significativos en estadios tempranos para la supervivencia al cáncer colorrectal en Zamora

    Por: MARIA ASUNCION JUANES BELLIDO — Diciembre 1st 2024 at 00:00

    Introducción: Se analiza la supervivencia libre de enfermedad (SLE), y la supervivencia global (SG) y/o éxitus de pacientes con cáncer colorrectal (CCR) cuyos factores pronósticos significativos para la supervivencia son el estadio, grado y tipo histológico, localización, TNM (tamaño, ganglios, metástasis) , invasión linfática, vascular y perineural, edad y sexo. Objetivo. Analizar la SG Y SLE en intervenidos con cirugía radical de CCR en relación a estadios I, II, III.Material y métodos. Estudio observacional descriptivo retrospectivo de informes Anatomo-patológicos y datos registrados de historias en Jimena de 468 pacientes intervenidos de CCR desde 1 enero del 2015 hasta 31 de diciembre del 2022. Resultados. Se obtuvo una supervivencia del 77,9 %. Se consiguió una supervivencia 94,4% en estadio I. En II, el 81,3%. y III el 69%. Se observó de 60 a 69 años en estadio I, en estadios II y III el grupo es de 70 a 79 seguido de 80 a 89 años. Se objetivó en el estadio I mayor probabilidad de supervivencia que los de estadios II y III, siendo el riesgo de morir más elevado (riesgo > 0,6 a partir de los 4 años). Se alcanzó una SLE superior al 0,7 y riesgo de recaída se estabiliza en 0,35 a partir de los 4 años. Discusión. La localización del tumor también puede influir en el pronóstico del cáncer colorrectal, ya que se ha observado que los tumores ubicados en el colon derecho tienden a tener peores resultados que aquellos en el colon izquierdo.

    ABSTRACT

    Introduction. We analyze disease-free survival (DFS), overall survival (OS) and/or deaths of patients with colorectal cancer (CRC) whose significant prognostic factors for survival are stage, grade and histological type, location, TNM (size, nodes, metastases), lymphatic, vascular and perineural invasion, age and sex. Objective: To analyze the OS and DFS in patients undergoing radical CRC surgery in relation to stages I, II, III. Methodology. A retrospective descriptive observational study of Anatomical-pathological reports and data recorded from histories in Jimena of 468 patients operated on for CRC since January 1 from 2015 to December 31, 2022. Results. A survival of 77.9% was obtained. A survival rate of 94.4% was achieved in stage I. In stage II, 81.3%. and III 69%. It was observed from 60 to 69 years in stage I, in stages II and III the group is from 70 to 79 followed by 80 to 89 years. A greater probability of survival was observed in stage I than in stages II and III, with the risk of dying being higher (risk > 0.6 from 4 years of age). SLE greater than 0.7 was achieved and the risk of relapse stabilizes at 0.35 after 4 years. Discussion. Location of the tumor may influence on cancer prognosis, as it has been observed that tumors ubicated on right colon tend to have worse results than those ubicated on left colon.

    ☐ ☆ ✇ Archivos de la Memoria

    El paso por una unidad de cuidados intensivos y el regreso a la vida

    Por: José Carlos Bellido Vallejo — Julio 17th 2019 at 13:10

    Existen procesos respiratorios que requieren ingreso en una UCI, ventilación mecánica, sedación e inmovilidad; junto a esta necesaria asistencia técnico-sanitaria existe todo un mundo de sentimientos, sensaciones, temores y emociones del paciente y sus familiares. Juan es un enfermero que se ve inmerso en un ingreso hospitalario con estancia prolongada en la UCI. Este vital acontecimiento, le supone superar una situación de extremada gravedad, pero también la aparición de úlceras por presión y otras limitaciones. Su condición de profesional de la salud crea una doble perspectiva que hace muy interesante su relato, permitiéndole profundizar en su enfermedad, la estancia en UCI, la asistencia sanitaria, la recuperación, etc., hechos que llevan sin duda a la reflexión. A través de su narración, cargada de emociones y sentimientos, vivimos la enorme experiencia que supone encontrarse al borde de la muerte, regresar a la vida y el enorme esfuerzo y lucha que supone la recuperación

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