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PRoVENT-iMIC
PRactice of VENTilation in Critically Ill Patients in Middle-Income Countries (PRoVENT-iMIC) - an International Multicenter Service Review Focusing on ICUs in Asia
Sponsor study identifier
observational
1,315
10 countries
51
Study Start
November 1, 2017
Actual (reported)Primary Completion
November 29, 2018
Actual (reported)Study Completion
January 29, 2019
Actual (reported)The purpose of this international, multicenter service review is to describe and compare ventilation management in patients at risk of acute respiratory distress syndrome (ARDS) versus patients not at risk and patients with established ARDS, and to ascertain whether certain ventilator settings and ventilation parameters are associated with pulmonary complications or development of ARDS after start of ventilation in patients in intensive care units (ICUs) in Asian countries. Participating centers will include adult patients undergoing mechanical ventilation in the ICU during a 28-day period. Patients' data will be collected during the first 7 days in the ICU, or until ICU discharge. Follow up is until ICU discharge. The primary outcome includes two main ventilator settings, i.e., tidal volume and the level of positive end-expiratory pressure. Secondary endpoints are development of ARDS in patients without ARDS at the onset of mechanical ventilation, worsening of ARDS in patients with ARDS at the onset of mechanical ventilation, pulmonary infection, other pulmonary complications, need for tracheostomy, duration of ventilation, length of ICU stay and ICU mortality.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 29, 2019
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 12, 2017
Actual (reported)June 15, 2017
Actual (reported)November 1, 2017
Actual (reported)November 29, 2018
Actual (reported)January 29, 2019
Actual (reported)Tidal volume size
Tidal volume size in milliliters per kilogram of predicted body weight
Day 1 to Day 3 from initiation of mechanical ventilation
Positive end-expiratory pressure
Pressure in cm of water
Day 1 to Day 3 from initiation of mechanical ventilation
Patients at risk of ARDS
On the date of inclusion
Inspired Oxygen Concentration
Day 1 to Day 3 from initiation of mechanical ventilation
Plateau pressure
Day 1 to Day 3 from initiation of mechanical ventilation
Peak pressure
Day 1 to Day 3 from initiation of mechanical ventilation
Driving pressure
Day 1 to Day 3 from initiation of mechanical ventilation
Patients under mechanical ventilation in the ICU
consecutive intubated and ventilated intensive care unit patients
Chittagong Medical College Hospital
Chittagong, Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh
BIRDEM General Hospital
Dhaka, Bangladesh
Dhaka Medical College Hospital
Dhaka, Bangladesh
Rajshahi Medical College Hospital
Rajshahi, Bangladesh
Sylhet MAG Osmani Medical College Hospital
Sylhet, Bangladesh
Ispat General Hospital
Raurkela, Odisha, India
Serpa Neto A, Cardoso SO, Manetta JA, Pereira VG, Esposito DC, Pasqualucci Mde O, Damasceno MC, Schultz MJ. Association between use of lung-protective ventilation with lower tidal volumes and clinical outcomes among patients without acute respiratory distress syndrome: a meta-analysis. JAMA. 2012 Oct 24;308(16):1651-9. doi: 10.1001/jama.2012.13730.
Neto AS, Barbas CSV, Simonis FD, Artigas-Raventos A, Canet J, Determann RM, Anstey J, Hedenstierna G, Hemmes SNT, Hermans G, Hiesmayr M, Hollmann MW, Jaber S, Martin-Loeches I, Mills GH, Pearse RM, Putensen C, Schmid W, Severgnini P, Smith R, Treschan TA, Tschernko EM, Melo MFV, Wrigge H, de Abreu MG, Pelosi P, Schultz MJ; PRoVENT; PROVE Network investigators. Epidemiological characteristics, practice of ventilation, and clinical outcome in patients at risk of acute respiratory distress syndrome in intensive care units from 16 countries (PRoVENT): an international, multicentre, prospective study. Lancet Respir Med. 2016 Nov;4(11):882-893. doi: 10.1016/S2213-2600(16)30305-8. Epub 2016 Oct 4.
Marcus J Schultz, MD, PhD
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Arjen M Dondorp, MD, PhD
Mahidol Oxford Research Unit, University of Oxford
Luigi Pisani, MD
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ary Serpa Neto, MD, MSc
Hospital Israelita Albert Einstein
1,315 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2017
First Posted
June 15, 2017
Study Start
November 1, 2017
Actual (reported)Contact the study team to confirm eligibility.
St. John's Medical College
Bangalore, India
Bharati Vidyapeeth Medical College
Pune, India
Modarres Hospital
Tehran, Iran
Pars Hospital
Tehran, Iran
Masih Daneshvari Hospital
Tehrān, Iran
Monash University
Johor Bahru, Malaysia
Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Mohamad Irfan Bin Othman Jailani
Kuala Lumpur, Malaysia
International Islamic University Medical Center
Kuantan, Malaysia
Indira Gandhi Memorial Hospital
Malè, Maldives
Patan Academy of Health Sciences
Kathmandu, Nepal
Allied Hospital
Faisalābad, Pakistan
PIMS
Islamabad, Pakistan
Shifa International Hospital
Islamabad, Pakistan
Aga Khan University Hospital MICU
Karachi, Pakistan
Aga Khan University SICU
Karachi, Pakistan
Patel Hospital
Karachi, Pakistan
Doctor's Hospital
Lahore, Pakistan
National Hospital and Medical Center
Lahore, Pakistan
Peoples Medical College Hospital
Nawabshah, Pakistan
North West General Hospital
Peshawar, Pakistan
Batticaloa Base Hospital
Batticaloa, Sri Lanka
Colombo South Teaching Hospital MICU
Colombo, Sri Lanka
Colombo South Teaching Hospital SICU
Colombo, Sri Lanka
Lanka Hospital
Colombo, Sri Lanka
National Hospital Sri Lanka MICU
Colombo, Sri Lanka
National Hospital Sri Lanka SICU
Colombo, Sri Lanka
Sri Jayawardenepura CTICU
Colombo, Sri Lanka
Sri Jayewardenepura General Hospital GICU
Colombo, Sri Lanka
Karapitiya Teaching Hospital
Galle, Sri Lanka
Jaffna Teaching Hospital
Jaffna, Sri Lanka
Puttlam Hospital
Puttalam, Sri Lanka
Chulalongkorn University Hospital
Bangkok, Thailand
Hospital for Tropical Diseases, Mahidol University
Bangkok, Thailand
Ramathibodi Hospital
Bangkok, Thailand
Sriraj Hospital
Bangkok, Thailand
Vajira Hospital
Bangkok, Thailand
Chiang Mai Hospital Surgical ICU
Chiang Mai, Thailand
Chiang Mai Medical ICU
Chiang Mai, Thailand
Nakornping Hospital
Chiang Mai, Thailand
Prince of Songkla University
Hat Yai, Thailand
Srinakharinwirot University
Ongkharak, Thailand
National Hospital for Tropical Diseases
Hanoi, Vietnam
Oxford University Clinical Research Unit
Ho Chi Minh City, Vietnam
Serafini SC, Cinotti R, Asehnoune K, Battaglini D, Robba C, Neto AS, Pisani L, Mazzinari G, Tschernko EM, Schultz MJ; PRoVENT, the PRoVENT-iMiC and ENIO, investigators. Potentially modifiable ventilation factors associated with outcome in neurocritical care vs. non-neurocritical care patients: Rational and protocol for a patient-level analysis of PRoVENT, PRoVENT-iMiC and ENIO (PRIME). Rev Esp Anestesiol Reanim (Engl Ed). 2025 May;72(5):501690. doi: 10.1016/j.redare.2025.501690. Epub 2025 Feb 15.
Serafini SC, van Meenen DMP, Pisani L, Neto AS, Ball L, de Abreu MG, Algera AG, Azevedo L, Bellani G, Dondorp AM, Fan E, Laffey JG, Pham T, Tschernko EM, Schultz MJ, van der Woude MCE; ERICC; LUNG SAFE; PRoVENT; PRoVENT-iMiC-investigators. Different ventilation intensities among various categories of patients ventilated for reasons other than ARDS--A pooled analysis of 4 observational studies. J Crit Care. 2024 Jun;81:154531. doi: 10.1016/j.jcrc.2024.154531. Epub 2024 Feb 10.
Pisani L, Algera AG, Serpa Neto A, Ahsan A, Beane A, Chittawatanarat K, Faiz A, Haniffa R, Hashemian R, Hashmi M, Imad HA, Indraratna K, Iyer S, Kayastha G, Krishna B, Moosa H, Nadjm B, Pattnaik R, Sampath S, Thwaites L, Tun NN, Yunos NM, Grasso S, Paulus F, de Abreu MG, Pelosi P, Dondorp AM, Schultz MJ; PRoVENT-iMIC investigators, MORU and the PROVE network. 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. BMJ Open. 2018 Apr 28;8(4):e020841. doi: 10.1136/bmjopen-2017-020841.
Primary Completion
November 29, 2018
Actual (reported)Study Completion
January 29, 2019
Actual (reported)Last Updated
July 5, 2019
Record last verified: 2019-07
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Source: ClinicalTrials.gov.
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