Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
1315 participants
OBSERVATIONAL
2017-11-01
2019-01-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison Between Limited Driving Pressure Ventilation and Conventional Mechanical Ventilation Strategies in Medical Intensive Care Patients With Acute Respiratory Failure
NCT04035915
Practice of Ventilation in Critically Ill Patients Without ARDS
NCT01868321
PRotective VENTilation in Patients Without ARDS
NCT02153294
Third International Study on Mechanical Ventilation
NCT01093482
Pulmonary and Ventilatory Effects of Bed Verticalization in Patients With Acute Respiratory Distress Syndrome
NCT04371016
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Objective:The primary objective is to describe and compare ventilation management in patients at risk of ARDS versus individuals not at risk, and patients with established ARDS, and to ascertain whether certain ventilation settings are associated with a higher incidence of developing ARDS in patients in ICUs in Asia. PRoVENT-iMIC secondary objectives are to determine the epidemiological characteristics and clinical outcomes of patients at risk of ARDS in ICUs in Asia according to the ventilation practice applied.
Primary hypothesis: a large proportion of patients at risk of ARDS in ICUs in Asia do not receive so-called protective ventilation, defined as tidal volume \< 8 ml/kg predicted body weight and a level of positive end-expiratory pressure of at least 5 cm H2O.
Secondary hypothesis: in ICUs in Asia a large proportion of patients is at risk of ARDS, as stratified by a Lung Injury Prediction Score of ≥4.
Study design: an international multicenter service review focusing on ICUs in selected middle-income Asian countries.
Population: consecutive intubated and ventilated ICU patients.
Methods: Patients in participating ICUs will be screened daily during a 28-day period. A registry of limited demographic data will be compiled on all screened patients. Collection of ventilation characteristics is restricted to the first three days. The first seven days or up to death, whichever comes first, will be used for collection of patient demographics (on day of admission), development of ARDS and other pulmonary complications. All patients will be followed until ICU-discharge to determine length of stay in ICU and ICU mortality. The inclusion period will be flexible for participating centers and determined at a later stage together with the study-coordinator. Data will be coded by a patient identification number of which the code will be kept safe at the local sites. The data will be transcribed by local investigators onto an internet based electronic case report form (https://www.project-redcap.org).
Centers: about 60 Asian ICUs from ten countries are expected to participate in this international multicenter study. Each participating center will recruit \~ 50 patients.
Ethics Approval: The Oxford Tropical Research Ethical Committee has evaluated the study and considered it exempt from ethical review on the 1st of June 2017. National coordinators will be responsible for clarifying the need for ethics approval and applying for this where appropriate according to local policy. Centers will not be permitted to record data unless ethics approval or an equivalent waiver is in place.
Monitoring: Due to the observational nature of the study, a Data Safety and Monitoring Board is not necessary.
Sample Size Calculation: a formal sample size calculation was not performed, seen the largely descriptive character of this investigation. 3000 patients are expected to be enrolled in the study period, which will be sufficient to test the hypotheses.
Statistical Analysis: Patient characteristics will be compared and described by appropriate statistics. Student's t-test or Mann-Whitney U-tests are used to compare continuous variables and chi-squared tests are used for categorical variables. Data are expressed as means (SD), medians (interquartile range) and proportions as appropriate. Comparisons between and within groups are performed using one-way ANOVA and post-hoc analyses for continuous variables.
The primary analysis concerns the determination of (variation of) tidal volume and PEEP levels in patients without ARDS. These are compared between predefined patient groups: patients at no risk for ARDS, patients at risk for ARDS, patients with mild ARDS, and patients with moderate or severe ARDS.
To identify potential factors associated with outcome like development of ARDS, or worsening of ARDS, development of pulmonary complications, duration of ventilation, or death, univariate analyses are performed. A multivariate logistic regression model is used to identify independent risk factors. A stepwise approach is used to enter new terms into the model, with a limit of p \< 0.2 to enter the terms. Time to event variables are analyzed using Cox regression and visualized by Kaplan-Meier.
Organization: The study is conducted by the PROtective VEntilation Network (PROVENet). National co-ordinators will lead the project within individual nations and identify participating hospitals, translate study paperwork, distribute study paperwork and ensure necessary regulatory approvals are in place. They provide assistance to the participating clinical sites in trial management, record keeping and data management. Local coordinators in each site will supervise data collection and ensure adherence to Good Clinical Practice during the trial.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mechanical Ventilation
Patients under mechanical ventilation in the ICU
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Intubated in the ICU, or in the emergency room, general ward, or operation room before the present ICU admission
Exclusion Criteria
* Patients under invasive mechanical ventilation previous to the 28-day period of inclusion
* Patients transferred from another hospital under invasive mechanical ventilation
* Receiving only non-invasive ventilation (i.e., patient never received invasive ventilation during the present admission)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Mahidol Oxford Tropical Medicine Research Unit
OTHER
Hospital Israelita Albert Einstein
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Dr. Marcus J. Schultz
Prof.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marcus J Schultz, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Arjen M Dondorp, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Mahidol Oxford Research Unit, University of Oxford
Luigi Pisani, MD
Role: STUDY_DIRECTOR
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Ary Serpa Neto, MD, MSc
Role: STUDY_CHAIR
Hospital Israelita Albert Einstein
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Study website
Protective Ventilation Network website
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRoVENT-iMIC
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.