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.

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 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.

NCT03963622.

Healthcare professionals are increasingly burdened by clerical tasks, contributing to reduced job satisfaction, heightened burnout and potential risk for patient safety. Despite ongoing efforts to promote patient-centred care, direct interaction time with patients remains limited, affecting both professional fulfillment and the quality of patient experience. In response, hospitals have begun implementing structured programmes to enhance protected patient time, though their effectiveness remains uncertain. The Geneva University Hospitals (HUG) developed the ‘More Time at Patients’ Side’ (MTP) programme, integrating Lean management and Design Thinking principles to optimise clinical interactions. This study aims to evaluate an MTP booster intervention, designed to reinforce selected programme elements, using a cluster-randomised controlled trial focusing on patient pain management and healthcare professional job satisfaction.

The MTP Booster will be implemented in selected units at HUG across internal medicine, surgery, rehabilitation, palliative care and paediatrics units. Originally launched in 2017, the MTP programme introduced structured medical rounds, delegated clerical tasks and communication tools such as patient whiteboards. The booster intervention follows a stepped-wedge cluster-randomised design, with immediate reactivation in intervention units and delayed implementation in control units. The intervention consists of two key components: (A) a collaborative selection of MTP elements to reinforce, based on their feasibility and perceived usefulness and (B) structured integration of audit and feedback into daily routines, including on-site observations and staff training. The primary outcome is the quality of pain management, measured by the timely administration of analgesia. Secondary outcomes include pain documentation, patient satisfaction, healthcare professional work satisfaction, burnout levels, turnover risk and absenteeism. Other MTP-related audits are suspended during the study to preserve methodological integrity, and concurrent institutional initiatives will be documented as potential confounders.

The trial has a declaration of no objection by Swissethics (2024-00169). All final results will be reported in accordance with the Consolidated Standards of Reporting Trials extended for cluster-randomised trials. We intend to publish the results of this trial in an international peer-reviewed journal, irrespective of the results.

The trial is currently in the pre-results stage and is registered at ClinicalTrials.gov, ID: NCT06491797, 9 July 2024.

Perioperative psychological symptoms are prevalent among patients undergoing lung surgery and can contribute to adverse clinical outcomes. Pharmacological interventions for these symptoms have inherent limitations. Transcutaneous auricular vagus nerve stimulation (taVNS) has emerged as a promising non-invasive therapeutic approach. This study aims to evaluate the efficacy of taVNS in managing perioperative psychological symptoms in patients undergoing elective thoracoscopic pneumonectomy under general anaesthesia.

This single-centre, prospective, randomised, double-blind, controlled trial will enrol 176 patients scheduled for elective thoracoscopic lung resection. Participants will be randomly allocated to either the active taVNS or the sham taVNS groups in a 1:1 ratio. Both groups will receive 30 min active or sham stimulation sessions at four time points: (1) the afternoon prior to surgery, (2) the morning of the surgery, (3) following extubation and (4) the first afternoon postsurgery. The primary outcome is the incidence of perioperative anxiety, assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale. Secondary outcomes include depression scores, stress index, sleep quality, pain scores, incidence of postoperative delirium, fatigue, cough symptoms and postoperative recovery quality, all evaluated through validated assessment tools. Analyses will be conducted using intention-to-treat and per-protocol populations.

The Ethics Committee of Affiliated Hospital of Xuzhou Medical University granted approval for the study with approval number: XYFY2024-KL444-01. Dissemination will be via national anaesthesia conferences and publication in the peer-reviewed literature.

ChiCTR2400090542.

Ischaemic stroke, the most prevalent stroke subtype, imposes a significant long-term disease burden. However, patients with first-ever stroke exhibit substantial individual variability in poststroke health trajectories, manifesting heterogeneous clinical presentations. We therefore started with the overall health of patients in order to delineate heterogeneous clusters characterised by distinct demographic profiles, clinical features and behavioural determinants and elucidate shared longitudinal trajectories in the temporal development of adverse health outcomes.

We designed a multicentre, cross-sectional and longitudinal study focusing on patients with first-ever ischaemic stroke. We will employ patient self-reported outcomes and objective measurements to comprehensively evaluate patients’ health status from a multidimensional perspective. Following baseline assessments, participants will undergo follow-up evaluations at 1 month, 3 months and 6 months post inclusion. The primary objective is twofold: (1) to identify distinct patient clusters with heterogeneous multidimensional health profiles using the k-prototype clustering algorithm and (2) to characterise synergistic trajectories of core health attributes within the largest cluster through parallel process latent class growth modelling. By combining cross-sectional and longitudinal analyses, this phased study should elucidate static heterogeneity and dynamic recovery patterns following a first-ever ischaemic stroke.

The project conforms to the ethical principles enshrined in the Declaration of Helsinki (2013 amendment) and all local ethical guidelines. The ethics committee at the University of South China approved the study (approval no. 2024 NHHL023). The ethics committee of Gansu Provincial Hospital approved the study (approval no. 2025–023). The ethics committee of the Central Hospital of Shaoyang approved the study (approval no.KY-2025–12). The findings will be published and presented at conferences for widespread dissemination.

Trial registration number: ChiCTR2500098442

Giant cell arteritis (GCA) is a large-vessel vasculitis occurring in people aged over 50 years. Recent studies have shown that tocilizumab (TCZ), an anti-IL-6 receptor monoclonal antibody, is remarkably effective in treating GCA and allows significant dose sparing of glucocorticoids. However, it makes it difficult to monitor disease activity. Furthermore, treatment is often prolonged over 1 year due to the fear of relapse after stopping TCZ and/or the absence of an optimal discontinuation scheme.

This study aims at comparing two discontinuation regimens in a population of GCA patients who have been treated with TCZ for 12–36 months and have discontinued glucocorticoids for at least 12 weeks. Patients will be randomised with a 1:1 ratio between two arms: immediate discontinuation (cessation) versus gradual discontinuation of TCZ (162 mg subcutaneously every 2 weeks for 12 weeks and then every 4 weeks for 12 additional weeks). Patients will be followed up for 78 weeks. The primary endpoint is relapse-free survival after 26 weeks of follow-up. A total of 120 patients will be randomised (60 in each group) for a period of 3 years.

The trial was approved by an independent ethics committee (CPP Sud Ouest et Outre Mer IV) and the French health authority (French National Agency for Medicines and Health Products Safety—ANSM) through the Clinical Trials Information System (CTIS) provided by the European Medicines Agency (EMA). The informed consent complies with the ICH GCP guideline and regulatory requirements. Eligible patients may only be included in the study after providing informed consent. Findings will be published in peer-reviewed journals and conference presentations.

NCT06037460.

Postoperative delirium is a serious complication occurring in 10.09%–51.28% of geriatric patients undergoing surgery for hip fractures. Delirium has resulted in poorer functional recovery, increased readmission rates, repeat surgeries and elevated mortality. Perioperative music listening is a promising non-pharmacological intervention with beneficial effects on delirium. This trial aims to evaluate the effect of perioperative music listening on postoperative delirium in patients with femur fracture undergoing surgery.

The music listening on clinical outcome after hip fracture operations study is an investigator-initiated, randomised controlled, clinical trial. 102 patients with femur fracture meeting eligibility criteria will be randomised to the music listening intervention or control group with concealed allocation. The perioperative music intervention consists of preselected lists totalling 4 hours of music (classical, jazz and pop). The primary outcome is postoperative delirium rate. Secondary outcome measures include pain score and opioid medication requirement, postoperative complications, hospital length of stay, 14-day readmission rate and 30-day mortality. A 90-day follow-up will be performed in order to assess readmission rate and mortality rate. Data will be analysed according to an intention-to-treat principle.

The study protocol was approved by the Research Ethics Committee of Ditmanson Medical Foundation of Chia-Yi Christian Hospital (IRB2023084). The trial will be carried out following the Declaration of Helsinki principles and Good Clinical Practice guidelines. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal and presented at scientific conferences. Data availability statement: data generated by this study will be made available on reasonable request. A data sharing plan has been submitted to ClinicalTrials.gov in compliance with ICMJE (International Committee of Medical Journal Editors) and BMJ Open data policies.

NCT06209788.