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Intensive care
Protocol
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
  1. Luigi Pisani1,2,
  2. Anna Geke Algera1,
  3. Ary Serpa Neto1,3,
  4. Areef Ahsan4,
  5. Abigail Beane2,
  6. Kaweesak Chittawatanarat5,
  7. Abul Faiz2,6,
  8. Rashan Haniffa2,
  9. Reza Hashemian7,
  10. Madiha Hashmi8,
  11. Hisham Ahmed Imad9,
  12. Kanishka Indraratna10,
  13. Shivakumar Iyer11,
  14. Gyan Kayastha12,
  15. Bhuvana Krishna13,
  16. Hassan Moosa14,
  17. Behzad Nadjm15,
  18. Rajyabardhan Pattnaik16,
  19. Sriram Sampath13,
  20. Louise Thwaites17,
  21. Ni Ni Tun18,
  22. Nor’azim Mohd Yunos19,
  23. Salvatore Grasso20,
  24. Frederique Paulus1,
  25. Marcelo Gama de Abreu21,
  26. Paolo Pelosi22,
  27. Arjen M Dondorp1,2,
  28. Marcus J Schultz1,2,23
  29. for the PRoVENT–iMIC investigators, MORU and the PROVE network
  1. 1 Department of Intensive Care, Academic Medical Center, Amsterdam, The Netherlands
  2. 2 Mahidol Oxford Tropical Medicine Research Unit (MORU), Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
  3. 3 Department of Intensive Care Medicine, Hospital Israelita Albert Einstein, São Paulo, Brazil
  4. 4 Department of Critical Care, BIRDEM General Hospital, Dhaka, Bangladesh
  5. 5 Department of Surgery, Chiang Mai University, Chiang Mai, Thailand
  6. 6 Dev Care Foundation, Chittagong, Bangladesh
  7. 7 National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
  8. 8 Department of Anaesthesiology, Aga Khan University, Karachi, Pakistan
  9. 9 Department of Clinical Tropical Medicine, Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
  10. 10 Department of Intensive Care, Sri Jayewardenepura General Hospital, Nugegoda, Sri Lanka
  11. 11 Department of Medicine, Bharati Vidyapeeth Medical College, Pune, Maharashtra, India
  12. 12 Department of Internal Medicine, Patan Academy of Health Sciences, Kathmandu, Nepal
  13. 13 Department of Critical Care Medicine, St. John’s Medical College, Bangalore, India
  14. 14 Department of Intensive Care, Indira Gandhi Memorial Hospital, Malé, Maldives
  15. 15 Oxford University Clinical Research Unit, National Hospital for Tropical Diseases, Hanoi, Vietnam
  16. 16 Critical Care Unit, Ispat General Hospital, Rourkela, Orissa, India
  17. 17 Oxford University Clinical Research Unit, Hospital for Tropical Diseases, Ho Chi Minh City, Vietnam
  18. 18 Medical Action Myanmar, Naypyidaw, Myanmar
  19. 19 Jeffrey Cheah School of Medicine and Health Sciences, Monash University Malaysia, Johor, Malaysia
  20. 20 Department of Emergency and Organ Transplantation (DETO), University of Bari, Bari, Italy
  21. 21 Pulmonary Engineering Group, Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany
  22. 22 Department of Surgical Sciences and Integrated Diagnostics, San Martino Policlinico Hospital, IRCCS for Oncology, University of Genoa, Genoa, Italy
  23. 23 Laboratory of Experimental Intensive Care and Anesthesiology (LEICA), Academic Medical Center, Amsterdam, The Netherlands
  1. Correspondence to Dr Luigi Pisani; luigipisani{at}gmail.com

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.

  • Mechanical Ventilation
  • Invasive Ventilation
  • Ards
  • Outcomes
  • Middle-income Countries
  • Resource-limited Settings

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2017-020841

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    Footnotes

    • Contributors LP, AGA, ASN, AMD and MJS were equally responsible for writing of the manuscript and participated in study design. FP and PP participated in study design and assisted in writing of the manuscript. AA, AB, KC, AF, RaH, ReH, MH, HAI, KI, SI, GK, BK, HM, BN, RP, SS, LT, SG, NNT, NMY and MGdA reviewed the manuscript and agreed with submission.

    • Funding This research received no specific grant from any funding agency in the public, commercial or not–for profit sectors.

    • Competing interests None declared.

    • Patient consent Not required.

    • Ethics approval The Oxford Tropical Research Ethical Committee at the University of Oxford, UK, exempted the study from ethical review on the 9 June 2017.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Collaborators MORU, the Mahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand (www.tropmedres.ac). PROVE Network, the Protective Ventilation Network (www.provenet.eu).