Lung Protective Mechanical Ventilation in Severe Acute Brain Injured Patients: A Multicenter, Randomized Clinical Trial (PROLABI).

BACKGROUND: Lung protective strategies using low tidal volumes and moderate positive end expiratory pressures (PEEP) are considered best practice in critical care, but interventional trials have never been conducted in acutely brain-injured patients due to concerns about carbon dioxide control and effect of PEEP on cerebral hemodynamic. METHODS: In this multicenter, open-label, controlled clinical trial 190 adult acute brain injured patients were assigned to receive either a lung-protective or a conventional ventilatory strategy. The primary outcome was a composite endpoint of death, ventilator dependency and ARDS at day 28. Neurological outcome was assessed at intensive care unit discharge by Oxford Handicap Scale and at six months by Glasgow Outcome Scale. FINDINGS: The two study arms had similar characteristics at baseline. In the lung-protective and conventional strategy groups, using an intention-to-treat approach, the composite outcome at 28 days was 61.5% and 45.3% (RR 1.35; 95%CI 1.03-1.79; p=0.025). Mortality was 28.9% and 15.1% (RR 1.91; 95%CI 1.06-3.42; p=0.02), ventilator dependency was 42.3% and 27.9% (RR 1.52; 95%CI 1.01-2.28; p=0.039), and incidence of ARDS was 30.8% and 22.1% (RR 1.39; 95%CI 0.85-2.27; p=0.179) respectively. The trial was stopped after enrolling 190 subjects because of termination of funding. INTERPRETATION: In acutely brain-injured patients without ARDS a lung-protective ventilatory strategy as compared to a conventional strategy did not reduce mortality, percentage of patients weaned from mechanical ventilation, incidence of ARDS and was not beneficial in terms of neurological outcomes. Due to the early termination, these preliminary results require confirmation in larger trials. Clinical trial registration available at www. CLINICALTRIALS: gov, ID: NCT01690819.

ENFORCER, internet-based interventions for cardiac arrest survivors: A study protocol for a randomised, parallel-group, multicentre clinical trial.

Background: Out-of-hospital cardiac arrest (OHCA) is a major health concern in Europe, leading to significant morbidity and mortality. Survivors often suffer from cognitive deficits, anxiety, and depression, that affect significantly their quality of life. Current post-discharge care is inconsistent and frequently overlooks subtle but disabling symptoms. The ENFORCER trial aims to significantly enhance the health and quality of life of OHCA survivors by providing a comprehensive, accessible, and user-friendly internet-based lifestyle intervention. Methods: ENFORCER is a multicentre, parallel group randomized controlled trial involving OHCA survivors aged 18-80 years with cognitive impairment or anxiety/depression measured through validated instruments.Participants will be randomized 1:1 to the intervention or the control group. The intervention group will receive a one-year program via a secure web application, offering cognitive, emotional, and physical rehabilitation support. The control group will receive standard care.The primary outcome is the difference in the proportion of patients without cognitive or emotional symptoms between the two groups after one year.Secondary outcomes include changes in the level of patients' cognitive and emotional symptoms, quality of life, sleep quality, sexual interest and satisfaction, and caregivers' burden, quality of life, sleep quality and emotional symptoms in the two groups. Discussion: The trial addresses the need for consistent post-discharge care, and the timely detection and treatment of cognitive and emotional problems. The internet-based approach allows to potentially reach many patients, ensuring cost-effectiveness and high adherence rates.The study results could establish a standard for post-OHCA care, improving long-term recovery and quality of life for survivors.Trial registration.The trial is registered at clinicaltrials.gov (NCT06395558).

Evaluation of the feasibility and acceptability of a home-based supervised exercise programme in individuals with spinal cord injuries: SCI-HOME-ACTIVE study protocol.

Physical activity is essential to a healthy lifestyle for adults with spinal cord injuries (SCI). Although exercise is recognised as an important tool for improving the well-being and independence of people with SCI, most individuals do not engage in physical exercise. Traditional exercise programmes often require participation in rehabilitation centres or specialised facilities, making them less accessible for individuals with chronic SCI. Many people with SCI live in rural communities and other geographically isolated areas where access to fitness facilities and outdoor recreational areas involves long commutes or expensive transportation, which is one of the most common barriers to exercise reported by people with physical disabilities. Consequently, exercise remains an underused intervention for improving health and function in people with SCI despite its proven effects in reducing pain, fatigue, fall risk and other secondary health conditions. This pilot study evaluates the feasibility and acceptability of a home-based supervised exercise programme for individuals with chronic SCI. The study will be an interventional and prospective pilot study. People with SCI will participate in a 3-month home-based exercise programme. Primary outcomes will include adherence to the exercise programme, while secondary outcomes will encompass quality of life, functional capacity, musculoskeletal health and clinical parameters. The programme will be structured into 1-hour sessions, held twice weekly for 3 months, conducted online and in small groups. The results of this study could be relevant for future indications of the best setting and strategy to ensure adherence to physical activity.

Epilepsy after acute central nervous system complications of pediatric hematopoietic cell transplantation: A retrospective, multicenter study.

BACKGROUND: Acute central nervous system (CNS) complications are common and well described among pediatric patients undergoing haematopoietic cell transplantation (HCT). However, their long-term outcomes are not known. The aim of this study is to describe the incidence, characteristics, and risk factors of long-term epilepsy in pediatric patients with acute CNS complications of HCT. METHODS: This retrospective study included pediatric patients who developed acute CNS complications from autologous or allogeneic HCT between 2000 and 2022. Clinical, therapeutic and prognostic data including long-term outcomes were analyzed. A diagnosis of epilepsy was provided if unprovoked seizures occurred during follow-up. RESULTS: Ninety-four patients (63 males, 31 females, median age 10 years, range 1-21 years) were included. The most common acute CNS complications were posterior reversible encephalopathy syndrome (n = 43, 46 %) and infections (n = 15, 16 %). Sixty-five patients (69 %) had acute symptomatic seizures, with 14 (16 %) having one or more episodes of status epilepticus (SE). Nine patients (9.6 %) were diagnosed with long-term focal epilepsy during the follow-up (5-year cumulative incidence from the acute complication, 13.3 %). Acute symptomatic SE during neurological complications of HCT was associated with an increased risk of long-term epilepsy (OR=14, 95 % CI 2.87-68.97). CONCLUSIONS: A higher occurrence of epilepsy has been observed in our cohort compared to the general population. Acute symptomatic SE during HCT was associated with a higher risk of long-term epilepsy. Pediatric patients with CNS complications during HCT could benefit from specific neurological follow-up. Further studies are needed to characterize mechanisms of epileptogenesis in pediatric patients undergoing HCT.

Reasons influencing the nurses' prioritization process while preventing and managing delirium: findings from a qualitative study.

BACKGROUND: Nurses play an important role in the prevention and management of delirium episodes. However, some studies have reported that not all interventions recommended are applied due to time and resource constraints, resulting in patients receiving less care than required because other patients and/or interventions are prioritised. The concept of prioritization is part of the broader concept of decision-making as the ability to choose between two or more alternatives to ensure patient safety. Understanding the reasons influencing the prioritization process in patients at risk or with delirium may inform interventions to prevent and/or minimise the unfinished nursing care. AIM: The purpose of this study was to explore the reasons that inform the prioritisation process among nurses when they are challenged to make decisions for patients at risk and with delirium. METHODS: A descriptive qualitative study performed according to the COnsolidated criteria for Reporting guidelines, in 2021. An intentional sample of nurses working full-time with older patients in medical, geriatric, and post-acute care facilities affiliated with the National Health System was involved. Semi-structured interviews were conducted and narratives thematic analysed. RESULTS: A total of 56 nurses (55.4% in internal medicine, 26.8% in geriatrics and 17.8% in post-acute/intermediate care) participated with an average age of 31.6 years. The reasons informing the prioritisation process while providing preventive or managerial interventions towards a patient at risk of or with delirium are set at three levels: (1) unit level, as reasons belong to the inadequacy of the 'Environment', the 'Human Resources', and the 'Organisation and Work Processes', (2) nurse's level, as issues in 'Competencies' and 'Attitudes' possessed, and (3) patient level, due to the 'Multidimensional Frailty'. CONCLUSION: Nurses caring for patients at risk of and with delirium face several challenges in providing care. To prioritise preventive and managerial interventions, it is essential to implement multilevel and multifaced organizational and educational strategies.

Perceived Relational Empathy and Resilience in People with Spinal Cord Injury at the End of Acute Care: A Cross-Sectional Study.

In patients with spinal cord injury (SCI), patient-reported outcomes (PROMs) and experience of care measures (PREMs) are extremely relevant for the prognosis. However, there is a paucity of research on these topics. We conducted a cross-sectional study to investigate the relationships between these patient outcomes and other demographic and clinical variables in adult SCI patients discharged from the intensive care unit of an Italian tertiary rehabilitation hospital. We administered the Consultation and Relational Empathy (CARE) for perceived relational empathy, the Spinal Cord Independence Measure III self-report (SCIM-SR) for functional autonomy, the Numeric Rating Scale (NRS) for pain, and the Connor-Davidson Resilience Scale (CD-RISC-10) for resilience. Study participants consisted of 148 adults with SCI; 82.4% were male, with a mean age of 49.9 years (SD = 16.6). The lesion was traumatic in 82.4% and complete in 74.3% of cases. The median length of hospital stays was 35 days (interquartile range-IQR = 23-60). Perceived relational empathy was positively associated with resilience (r = 0.229, p = 0.005) and negatively associated with the length of the stay and lesion completeness. Resilience had a weak negative association with pain (r = -0.173, p = 0.035) and was unrelated to other variables. Clinicians should consider the routine assessment of PREMs and PROMs in order to personalize post-discharge therapeutic plans and identify appropriate measures to ensure continuity of care.

Role of age as eligibility criterion for ECMO in patients with ARDS: meta-regression analysis.

BACKGROUND: Age as an eligibility criterion for V-V ECMO is widely debated and varies among healthcare institutions. We examined how age relates to mortality in patients undergoing V-V ECMO for ARDS. METHODS: Systematic review and meta-regression of clinical studies published between 2015 and June 2024. Studies involving at least 6 ARDS patients treated with V-V ECMO, with specific data on ICU and/or hospital mortality and patient age were included. The search strategy was executed in PubMed, limited to English-language. COVID-19 and non-COVID-19 populations were analyzed separately. Meta-regressions of mortality outcomes on age were performed using gender, BMI, SAPS II, APACHE II, Charlson comorbidity index or SOFA as covariates. RESULTS: In non-COVID ARDS, the meta-regression of 173 studies with 56,257 participants showed a significant positive association between mean age and ICU/hospital mortality. In COVID-19 ARDS, a significant relationship between mean age and ICU mortality, but not hospital mortality, was found in 103 studies with 21,255 participants. Sensitivity analyses confirmed these findings, highlighting a linear relationship between age and mortality in both groups. For each additional year of mean age, ICU mortality increased by 1.2% in non-COVID ARDS and 1.9% in COVID ARDS. CONCLUSIONS: The relationship between age and ICU mortality is linear and shows no inflection point. Consequently, no age cut-off can be recommended for determining patient eligibility for V-V ECMO.

Spectrum of electrocardiographic abnormalities in a large cohort of cardiac masses.

BACKGROUND: Cardiac masses represent a heterogeneous clinical scenario. Potential electrocardiographic (ECG) red flags of malignancy remain to be investigated. OBJECTIVES: The purpose of this study was to describe the spectrum of ECG abnormalities in a large cohort of cardiac masses and to evaluate potential red flags suggestive of malignancy. METHODS: This was an observational cohort study of 322 consecutive patients with a cardiac mass and available ECG at Bologna University Hospital. All masses were diagnosed by histologic examination or, in the case of cardiac thrombi, by radiologic resolution after proper anticoagulant therapy. Multivariable regression analysis was used to assess potential predictors of malignancy among ECG abnormalities. All-cause mortality at follow-up was evaluated. RESULTS: Of 322 patients, 98 (30.4%) had malignant tumors. Compared with patients with benign masses, those with malignant tumors exhibited a higher heart rate, right-axis deviation, greater depolarization, repolarization abnormalities, and bradyarrhythmia at presentation. Regarding specific ECG features, a higher heart rate on admission (P = .014), bradyarrhythmias (P = .009), ischemic-like repolarization abnormalities (ST-segment deviation, both depression and elevation, and negative T-wave; P <.001), low voltages (P = .001), and right-axis deviation (P = .025) were identified as independent predictors of malignancy. Considering these specific ECG alterations, a malignancy-oriented ECG was associated with higher mortality at follow-up (median 20.7 months). CONCLUSION: ECG frequently is abnormal in cases of malignant cardiac tumors. Some specific ECG changes are strongly suggestive for malignancy and type of infiltration.

Nerve transfer for upper extremity reanimation in people with spinal cord injury: A 2-year follow-up case series.

OBJECTIVE: To describe the 2-year functional outcomes of nerve transfer (NT) for upper extremity reanimation. STUDY DESIGN: A prospective case series. SETTING: A highly specialized rehabilitation hospital for spinal cord injury (SCI) in Italy. INTERVENTION: Upper limb nerve transfer (32 NTs, 15 upper limbs). PARTICIPANTS: Twelve male individuals with traumatic SCI (AIS A or B, neurological level from C4 to C7) were enrolled; 24-month follow-up data were available for 11. OUTCOME MEASURES: We evaluated the strength recovery of recipient muscles through the Medical Research Council (MRC) Scale for Muscle Strength. Upper limb function and independence were assessed with the Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP) test version 1 and the Spinal Cord Independent Measure III (SCIM III). Patient satisfaction was also evaluated. RESULTS: After 24 months, median MRC scores (range) were: triceps 2 (1-2); extensor digitorum communis 3 (1-4); extensor pollicis longus 2.5 (1-4); flexor digitorum profundus 2 (0-4); flexor pollicis longus 2 (0-4). No complication occurred. GRASSP prehension ability and prehension performance total scores significantly improved at 24 months from 1 (0-4) to 2 (0-7) and from 1 (0-8) to 5 (0--22), respectively. The SCIM III self-care sub-scale score improved at 24-month follow-up (p = 0.009).This study has important limitations, including a limited generalizability of the results and a small sample size that does not allow definitive conclusions to be drawn. A large multicenter prospective study is needed to confirm our findings. CONCLUSIONS: NT represents a functional surgery option with few complications for the resuscitation of upper limbs in persons with tetraplegia.