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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

Pisani L 1 , Algera AG 1 , Serpa Neto A 1 , Ahsan A 2 , Beane A 3 , Chittawatanarat K 4 Show all authors , Faiz A 3 , Haniffa R 3 , Hashemian R 5 , Hashmi M 6 , Imad HA 7 , Indraratna K 8 , Iyer S 9 , Kayastha G 10 , Krishna B 11 , Moosa H 12 , Nadjm B 13 , Pattnaik R 14 , Sampath S 11 , Thwaites L 15 , Tun NN 16 , Yunos NM 17 , Grasso S 18 , Paulus F 1 , de Abreu MG 19 , Pelosi P 20 , Dondorp AM 1 , Schultz MJ 1 , PRoVENT–iMIC investigators, MORU and the PROVE network

Affiliations 

  • 1 Department of Intensive Care, Academic Medical Center, Amsterdam, The Netherlands
  • 2 Department of Critical Care, BIRDEM General Hospital, Dhaka, Bangladesh
  • 3 Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
  • 4 Department of Surgery, Chiang Mai University, Chiang Mai, Thailand
  • 5 National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  • 6 Department of Anaesthesiology, Aga Khan University, Karachi, Pakistan
  • 7 Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
  • 8 Department of Intensive Care, Sri Jayewardenepura General Hospital, Nugegoda, Sri Lanka
  • 9 Department of Medicine, Bharati Vidyapeeth Medical College, Pune, Maharashtra, India
  • 10 Department of Internal Medicine, Patan Academy of Health Sciences, Kathmandu, Nepal
  • 11 Department of Critical Care Medicine, St. John's Medical College, Bangalore, India
  • 12 Department of Intensive Care, Indira Gandhi Memorial Hospital, Malé, Maldives
  • 13 Oxford University Clinical Research Unit, National Hospital for Tropical Diseases, Hanoi, Vietnam
  • 14 Critical Care Unit, Ispat General Hospital, Rourkela, Orissa, India
  • 15 Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
  • 16 Medical Action Myanmar, Naypyidaw, Myanmar
  • 17 Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Johor, Malaysia
  • 18 Department of Emergency and Organ Transplantation (DETO), University of Bari, Bari, Italy
  • 19 Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
  • 20 Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy
BMJ Open, 2018 04 28;8(4):e020841.
PMID: 29705765 DOI: 10.1136/bmjopen-2017-020841

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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