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

Luigi Pisani, Anna Geke Algera, Ary Serpa Neto, Areef Ahsan, Abigail Beane, Kaweesak Chittawatanarat, Abul Faiz, Rashan Haniffa, Reza Hashemian, Madiha Hashmi, Hisham Ahmed Imad, Kanishka Indraratna, Shivakumar Iyer, Gyan Kayastha, Bhuvana Krishna, Hassan Moosa, Behzad Nadjm, Rajyabardhan Pattnaik, Sriram Sampath, Louise Thwaites, Ni Ni Tun, Nor'azim Mohd Yunos, Salvatore Grasso, Frederique Paulus, Marcelo Gama de Abreu, Paolo Pelosi, Arjen M Dondorp, Marcus J Schultz, PRoVENT–iMIC investigators, MORU and the PROVE network, Luigi Pisani, Anna Geke Algera, Ary Serpa Neto, Areef Ahsan, Abigail Beane, Kaweesak Chittawatanarat, Abul Faiz, Rashan Haniffa, Reza Hashemian, Madiha Hashmi, Hisham Ahmed Imad, Kanishka Indraratna, Shivakumar Iyer, Gyan Kayastha, Bhuvana Krishna, Hassan Moosa, Behzad Nadjm, Rajyabardhan Pattnaik, Sriram Sampath, Louise Thwaites, Ni Ni Tun, Nor'azim Mohd Yunos, Salvatore Grasso, Frederique Paulus, Marcelo Gama de Abreu, Paolo Pelosi, Arjen M Dondorp, Marcus J Schultz, PRoVENT–iMIC investigators, MORU and the PROVE network

Abstract

Introduction: Current 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 analysis: PRoVENT-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 dissemination: PRoVENT-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 number: NCT03188770; Pre-results.

Keywords: Ards; Invasive Ventilation; Mechanical Ventilation; Middle-income Countries; Outcomes; Resource-limited Settings.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Flow chart of inclusion of PRoVENT-iMIC. ARDS, acute respiratory distress syndrome; ICU, intensive care unit; LIPS, Lung Injury Prediction Score; MV, mechanical ventilation; PRoVENT-iMIC, PRactice of VENTilation in Middle-Income Countries.
Figure 2
Figure 2
Sequence of data submission in the electronic case report form. ARDS, acute respiratory distress syndrome; CPE, cardiogenic pulmonary oedema; ICU, intensive care unit; LIPS, Lung Injury Prediction Score; MV, mechanical ventilation.

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