Conectar
Cardiac arrest (CA) remains a major health burden with poor survival and poor neurological outcomes despite decades of advances in resuscitation science. Although high-quality cardiopulmonary resuscitation is essential, it provides only limited cerebral and coronary perfusion, and current strategies relying on high-dose epinephrine may adversely affect cerebral microcirculation. Resuscitative endovascular balloon occlusion of the aorta (REBOA) has emerged as a potential adjunct to improve coronary and cerebral perfusion without compromising microvascular blood flow. Although animal studies and small human case series suggest physiological and clinical benefits of REBOA in CA, randomised clinical trials are lacking.
This prospective, randomised controlled, single-centre clinical trial investigates the effect of REBOA during the treatment of CA. The planned study duration is 36 months, with a total of 98 patients to be randomised to either standard advanced life support (ALS) or ALS plus REBOA. Adult patients with an in-hospital CA, successful placement of a femoral artery introducer sheath and any electrical cardiac activity in the initial rhythm analysis are eligible for inclusion. Exclusion criteria comprise traumatic CA, asystole as the initial rhythm, pregnancy and CA occurring on intensive care units, in the operating room or in cardiac catheter laboratory. The primary outcome is sustained return of spontaneous circulation lasting for at least 20 min. Secondary and exploratory outcomes include survival, neurological outcome, changes in aortic blood pressure, end-tidal CO2 and near-infrared spectroscopy values as well as causes of death and vascular complications related to the intervention. Statistical analyses will be performed on a modified intention-to-treat basis.
The study protocol (Version 2.1, 11.02.2026) was approved by the Cantonal Ethics Committee of Cantone Bern (2025-D0108). Study results will be disseminated through peer-reviewed journals.
After resuscitation from out of hospital cardiac arrest (OHCA), mechanical ventilation (MV) and respiratory management are fundamental to support patients in the intensive care unit (ICU) and to minimise secondary brain injury. Best practices for MV and association with clinical outcomes in patients with OHCA remain unclear.
This protocol describes a pre-planned respiratory-focused series of sub-analyses within the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, an ongoing interventional study evaluating 6-month mortality after randomisation in patients admitted to ICUs following OHCA. The primary aim is to describe real-world ventilator settings and gas-exchange targets during the first 72 hours after ICU admission in patients receiving invasive mechanical ventilation after OHCA. Secondary aims include to estimate the incidence of respiratory complications during ICU stay (eg, ventilator-associated pneumonia, acute respiratory distress syndrome, barotrauma); and to explore the association between early ventilator settings/gas-exchange parameters and 6-month outcomes (mortality and neurological status). Exploratory aim is to characterise weaning and extubation practices, including timing and failure rates.
Eligible patients will include adult STEPCARE participants receiving invasive MV after return of spontaneous circulation with available respiratory data recorded within the STEPCARE database.
Data collected in the STEPCARE trial that will be analysed include patients’ prehospital characteristics; clinical examination at hospital admission and at ICU admission; ventilator settings and arterial blood gases recorded at predefined time points during ICU stay. In particular: MV setting (mode, tidal volume, positive end-expiratory pressure, fraction of inspired oxygen, tidal volume, mechanical power, plateau/driving pressures), gas-exchange values (arterial partial pressure of oxygen and carbon dioxide, pH, arterial saturation of oxygen), timing of measurements and the occurrence/timing of respiratory complications and weaning outcomes.
The STEPCARE study has been approved by the regional ethics committee at Lund University (Dnr 2022-02425-01, Approved IRB on 2022-06-18) and by all ethics boards in the participating countries. No additional ethical approval is required for this predefined secondary analysis, as no further data collection or interventions will be performed. Findings will be disseminated through publication in peer-reviewed journals and, where appropriate, conference abstracts and presentations. Patients and the public were not involved.
To report how person-centred care principles are applied to care planning and to explore the contextual factors affecting their implementation in older adult care homes in England.
A combined framework analysis and quantitative content analysis study.
Using a semi-structured questionnaire, we interviewed 22 care home managers in England, exploring topics around care planning processes. Audio recordings were transcribed verbatim. Transcripts were analysed through a combined framework approach and content analysis.
Most care home managers discussed person-centred care planning in terms of understanding residents' values and preferences and their engagement in decision-making. Factors facilitating person-centred planning implementation included accessible planning tools, supportive care home leadership, effective communication and collaborative partnerships. Inhibiting factors included regulatory and care practice misalignment, time constraints and adverse staffing conditions.
Differences between care home practitioners' understanding and practice of person-centred care planning require further examination to improve understanding of the sector's complexity and to develop suitable care planning instruments.
Findings demonstrate a need for improved staff access to specialised person-centred care training and an opportunity for care home nursing practitioners to lead the co-development of digital person-centred care planning tools that reflect the reality of long-term care settings.
Identifying factors influencing the implementation of holistic approaches to care planning makes clear the need for modernising long-term care policy and practice to adapt to the contemporary challenges of the care home sector.
Study reporting was guided by the Standards for Reporting Qualitative Research.
Two public involvement advisors with lived experience of caring for a relative living in a care home contributed to the development of the interview guide, advised on care home engagement, guided the interpretation of the findings and commented on the drafted manuscript.
To co-produce a prototype intervention to help nurses improve the assessment and care of the sexual health needs of men with inflammatory bowel disease.
Inflammatory bowel disease can have a significant impact on the sexual health and well-being of men, but has largely been neglected in research and clinical guidelines. Men with the disease report that sexual health is not discussed during consultations, while healthcare practitioners describe a lack of confidence to initiate sexual health assessments. At present, no evidence-based tool exists to support nurses in detecting, assessing, and providing care for the sexual health of men with the disease.
A mixed-methods study shaped by phase 1 of the Medical Research Council's framework for the development of complex interventions.
(1) Cross-sectional surveys of (i) men with inflammatory bowel disease, (ii) nurses, and (iii) inflammatory bowel disease services to determine the current state of sexual health provision across the UK National Health Service. (2) Semi-structured interviews with men and the partners of men with IBD and asynchronous focus groups with health professionals to explore appropriate and acceptable ways to provide sexual healthcare. (3) Three consecutive co-production workshops inclusive of men with the disease, healthcare professionals, and stakeholders to formulate a prototype intervention.
This study will create an evidence-based prototype intervention that will provide nurses with the knowledge and skills required to effectively assess the sexual health needs of men with inflammatory bowel disease and provide appropriate, patient-centred care.
The study design was supported by a patient group. The study delivery will be supported by a patient co-investigator and stakeholder group inclusive of men with lived experience of the disease.
This report adheres to the SPIRIT 2013 checklist for standard protocol items for clinical trials.
clinicaltrials.gov ID: NCT06562751
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