PRactice of VENTilation in Middle-Income Countries (PRoVENT-iMIC): rationale and protocol for a prospective international multicentre observational study in intensive care units in Asia

Abstract

IntroductionCurrent evidence on epidemiology and outcomes of invasively mechanically ventilated intensive care unit (ICU) patients is predominantly gathered in resource-rich settings. Patient casemix and patterns of critical illnesses, and probably also ventilation practices are likely to be different in resource-limited settings. We aim to investigate the epidemiological characteristics, ventilation practices and clinical outcomes of patients receiving mechanical ventilation in ICUs in Asia.Methods and analysisPRoVENT-iMIC (study of PRactice of VENTilation in Middle-Income Countries) is an international multicentre observational study to be undertaken in approximately 60 ICUs in 11 Asian countries. Consecutive patients aged 18 years or older who are receiving invasive ventilation in participating ICUs during a predefined 28-day period are to be enrolled, 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 cm H2O) during the first 3 days of mechanical ventilation—compared between patients at no risk for acute respiratory distress syndrome (ARDS), patients at risk for ARDS and in patients with ARDS (in case the diagnosis of ARDS can be made on admission). Secondary outcomes include occurrence of pulmonary complications and all-cause ICU mortality.Ethics and disseminationPRoVENT-iMIC will be the first international study that prospectively assesses ventilation practices, outcomes and epidemiology of invasively ventilated patients in ICUs in Asia. The results of this large study, to be disseminated through conference presentations and publications in international peer-reviewed journals, are of ultimate importance when designing trials of invasive ventilation in resource-limited ICUs. Access to source data will be made available through national or international anonymised datasets on request and after agreement of the PRoVENT-iMIC steering committee.Trial registration numberNCT03188770; Pre-results.

Addressing the information deficit in global health: lessons from a digital acute care platform in Sri Lanka

“…The digital intensive care unit (ICU) platform has increased availability of variables for benchmarking acuity of admissions and supported the validation of prognostic models 11 19 20 25. The platform has also facilitated participation in international multisite observational studies on ventilation management 26. Prior studies attempting to answer similar questions in this setting have highlighted challenges of lack of information, missing outcomes and small data sets.…”

“…In the acute care setting, the adapted mobile version of the digital platform has empowered nurses and doctors to adopt digital vital sign reporting (500 000 observations) in busy ward settings 28. Adaptation of an early warning score has helped identify over 4800 deteriorating ward patients by flagging patients who have deranged physiology on admission, for whom increased frequency of vital signs monitoring may be beneficial 26–28…”

“…Mobile interfaces are being developed for patient-reported information giving patient greater opportunity to participate in the decision regarding their care and guiding patient-led health service improvement. The dashboards are providing a real-time feedback to facilitate setting-specific research focused on evaluating and improving the quality of care, antibiotic use and time to referral for patients with myocardial infarction 19 20 26 30…”

ERS International Congress, Madrid, 2019: highlights from the Respiratory Intensive Care Assembly

“…Approximately half of patients with ARDS in LUNG SAFE [22] and patients without ARDS in PRoVENT [23] received lung protective ventilation with a low V T and PEEP. While awaiting a detailed report on PRoVENT-iMiC [14], it can already be concluded that lung protective ventilation is also used in ICUs where resources are low.…”

“…A worldwide perspective of ventilator management Marcus Schultz summarised the findings of three recent large service reviews of ventilator management in intensive care unit (ICU) patients: 1) the "Large Observational Study to Understand the Global Impact of Severe Acute Respiratory Failure" (LUNG SAFE) [12]; 2) the "PRactice of VENTilation in patients without ARDS" (PRoVENT) study [13]; and 3) the recently finished "PRactice of VENTilation in Middle-income Countries" (PRoVENT-iMiC) study [14].…”