BACKGROUND: Early mobilization has been proven effective for patients in intensive care units (ICUs) to improve functional recovery. However, early mobilization of critically ill, often mechanically ventilated, patients is cumbersome because of the attachment to tubes, drains, monitoring devices and muscle weakness. A mobile treadmill with bodyweight support may help to initiate mobilization earlier and more effectively. The aim of this study is to assess the effectiveness of weight-supported treadmill training in critically ill patients during and after ICU stay on time to independent functional ambulation. METHODS: In this randomized controlled trial, a custom-built bedside body weight-supported treadmill will be used and evaluated. Patients are included if they have been mechanically ventilated for at least 48 hours, are able to follow instructions, have quadriceps muscle strength of Medical Research Council sum-score 2 (MRC 2) or higher, can sit unsupported and meet the safety criteria for physical exercise. Exclusion criteria are language barriers, no prior walking ability, contraindications for physiotherapy or a neurological condition as reason for ICU admission. We aim to include 88 patients and randomize them into either the intervention or the control group. The intervention group will receive usual care plus bodyweight-supported treadmill training (BWSTT) daily. The BWSSTT consists of walking on a mobile treadmill while supported by a harness. The control group will receive usual care physiotherapy treatment daily consisting of progressive activities such as bed-cycling and active functional training exercises. In both groups, we will aim for a total of 40 minutes of physiotherapy treatment time every day in one or two sessions, as tolerated by the patient. The primary outcome is time to functional ambulation as measured in days, secondary outcomes include walking distance, muscle strength, status of functional mobility and symptoms of post-traumatic stress. All measurements will be done by assessors who are blinded to the intervention on the regular wards until hospital discharge. DISCUSSION: This will be the first study comparing the effects of BWSTT and conventional physiotherapy for critically ill patients during and after ICU stay. The results of this study contribute to a better understanding of the effectiveness of early physiotherapy interventions for critically ill patients. TRIAL REGISTRATION: Dutch Trial Register (NTR) ID: NL6766. Registered at 1 December 2017.
Background: The coronavirus disease 2019 (COVID-19) pandemic is rapidly expanding across the world, with more than 100,000 new cases each day as of end-June 2020. Healthcare workers are struggling to provide the best care for COVID-19 patients. Approaches for invasive ventilation vary widely between and within countries and new insights are acquired rapidly. We aim to investigate invasive ventilation practices and outcome in COVID-19 patients in the Netherlands.Methods: PRoVENT-COVID ('study of PRactice of VENTilation in COVID-19') is an investigator-initiated national, multicenter observational study to be undertaken in intensive care units (ICUs) in The Netherlands. Consecutive COVID-19 patients aged 18 years or older, who are receiving invasive ventilation in the participating ICUs, are to be enrolled during a 10-week period, with a daily follow-up of 7 days. The primary outcome is ventilatory management (including tidal volume expressed as mL/kg predicted body weight and positive end-expiratory pressure expressed as cmH2O) during the first 3 days of ventilation. Secondary outcomes include other ventilatory variables, use of rescue therapies for refractory hypoxemia such as prone positioning and extracorporeal membrane oxygenation, use of sedatives, vasopressors and inotropes; daily cumulative fluid balances; acute kidney injury; ventilator-free days and alive at day 28 (VFD-28), duration of ICU and hospital stay, and ICU, hospital and 90-day mortality.Discussion: PRoVENT-COVID will be the largest observational study to date, with high density ventilatory data and major outcomes. There is urgent need for a better understanding of ventilation practices, and the effects of ventilator settings on outcomes in COVID-19 patients. The results of PRoVENT-COVID will be rapidly disseminated through electronic presentations, such as webinars and electronic conferences, and publications in international peer-reviewed journals. Access to source data will be made available through local, regional and national anonymized datasets on request, and after agreement of the PRoVENT-COVID steering committee.Trial Registration: PRoVENT-COVID is registered at clinicaltrials.gov (identifier NCT04346342).
Objective: The aim of the study was to assess the effectiveness of intensive care unit (ICU)–initiated transitional care interventions for patients and families on elements of post-intensive care syndrome (PICS) and/or PICS-family (PICS–F). Review method used: This is a systematic review and meta-analysis Sources: The authors searched in biomedical bibliographic databases including PubMed, Embase (OVID), CINAHL Plus (EBSCO), Web of Science, and the Cochrane Library and included studies written in English conducted up to October 8, 2020. Review methods: We included (non)randomised controlled trials focussing on ICU-initiated transitional care interventions for patients and families. Two authors conducted selection, quality assessment, and data extraction and synthesis independently. Outcomes were described using the three elements of PICS, which were categorised into (i) physical impairments (pulmonary, neuromuscular, and physical function), (ii) cognitive impairments (executive function, memory, attention, visuo-spatial and mental processing speed), and (iii) psychological health (anxiety, depression, acute stress disorder, post-traumatic stress disorder, and depression). Results: From the initially identified 5052 articles, five studies were included (i.e., two randomised controlled trials and three nonrandomised controlled trials) with varied transitional care interventions. Quality among the studies differs from moderate to high risk of bias. Evidence from the studies shows no significant differences in favour of transitional care interventions on physical or psychological aspects of PICS-(F). One study with a nurse-led structured follow-up program showed a significant difference in physical function at 3 months. Conclusions: Our review revealed that there is a paucity of research about the effectiveness of transitional care interventions for ICU patients with PICS. All, except one of the identified studies, failed to show a significant effect on the elements of PICS. However, these results should be interpreted with caution owing to variety and scarcity of data. Prospero registration: CRD42020136589 (available via https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42020136589).