Nearly half of patients who receive invasive mechanical ventilation for acute respiratory failure require over 4 days of ventilator support, each day of which is associated with increased morbidity, mortality and cost. Many of these patients develop expiratory muscle atrophy and weakness, which are linked to failed extubation and weaning. We seek to test the hypothesis that exhalation synchronised abdominal functional electrical stimulation reduces mechanical ventilation duration.

This pivotal superiority trial will be performed in up to 30 intensive care units (ICUs) in the USA, France, the Netherlands and Australia. Adults (≥22 years old) who have been mechanically ventilated for 24–96 hours and are expected to remain ventilated for another 24+ hours are potentially eligible. We will recruit participants until 150 successful liberations from mechanical ventilation occur. To achieve this, we estimate that a maximum of 272 participants will be randomised in a 1:1 ratio to receive 30 min of active exhalation synchronised abdominal functional electrical stimulation (vs sham). The intervention will be applied using the VentFree Respiratory Muscle Stimulator two times per day, a minimum of 5 days per week, for a maximum of 28 days or until ICU discharge. The primary outcome is time from first intervention to successful liberation from mechanical ventilation. Secondary outcomes include cough peak flow (CPF) and maximum expiratory pressure (MEP) at 24 hours post-extubation, hospital and ICU length of stay, reintubations, complications, ICU readmissions, 90-day mortality and quality of life. The participant, clinical team and outcome assessor are blinded to group allocation. A positive outcome has the potential to improve patient-centred outcomes in ICUs.

This study was approved by local ethics institutions in the USA, Australia, France and the Netherlands. We describe the methods herein using the Standard Protocol Items for Randomised Trials framework and discuss key design decisions. The results will be disseminated through peer-reviewed journal publications, conference presentations and clinicaltrials.gov updates. Individual country-level approvals are as follows:

France:

Australia:

Netherlands:

USA:

All participating sites are currently approved and operating under protocol version 09 or later.

NCT05759013. Registered 8 March 2023.

Multimorbidity, defined as two or more chronic medical conditions, leads to the use of multiple medicines, including for cardiovascular conditions. This is associated with frailty and an increased risk of medication-related harm. Hospitalised adults have higher rates of multimorbidity and frailty compared with non-hospitalised adults. The aim of this study was to examine the use of medicines for hypertension, ischaemic heart disease and atrial fibrillation among patients with multimorbidity and frailty, who are generally not well represented in clinical trials.

A cross-sectional study was performed of adults aged ≥45 years with inpatient admissions during an 18-month period. Regular medications prescribed at discharge and coding data were obtained from the electronic medical record and hospital datasets.

The prevalence of multimorbidity (using coded chronic medical conditions or the RxRisk pharmaceutical comorbidity index), frailty (using hospital frailty risk score) and polypharmacy (defined as ≥5 medicines) were calculated. The uptake of medicines recommended by the Australian Therapeutic Guidelines for patients with coded hypertension, ischaemic heart disease and atrial fibrillation was also assessed.

Two large acute care, teaching hospitals in Adelaide, South Australia.

23 980 unique patients were identified.

69% (n=16 637) of patients had multimorbidity using the coding definition compared with 94% (n=22 620) using the pharmaceutical comorbidity score. 81% (n=19 366) had polypharmacy and 46% (n=11 091) had frailty. More than 85% of patients with hypertension were taking an antihypertensive. More than 75% of patients with ischaemic heart disease were taking an antithrombotic or a lipid-lowering agent and more than 50% were taking an agent acting on the renin-angiotensin system. Over 70% of patients with atrial fibrillation without a contraindication to anticoagulation were taking an anticoagulant. Patients with multimorbidity were 11–51% more likely to be taking an antihypertensive, antithrombotic or lipid-lowering medicine for the respective cardiovascular conditions, whereas those with frailty were 31–48% less likely to be taking guideline-directed medicines for all conditions studied.

Over two-thirds of hospitalised patients with these cardiovascular conditions were taking at least one guideline-directed medicine. Medication use was generally more common in multimorbidity and less common in frailty. Outcomes studies are needed to quantify the risks and benefits of cardiovascular medicines in these patients.

Although care for low-risk births in the Netherlands is primarily conducted by midwives, the use of consultant-led care has been increasing for a variety of indications, leading to a high patient burden for consultants. The induction of labour (IOL) of late-term pregnancies has historically been an indication for consultant-led care. This study by Velthuijs et...

As a result of the mass scale of production of plastics since the 1950s, microplastics, defined as particles 1 Microplastics have been linked to reproductive toxicity in both cell culture...

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