Mechanical VentilationPRoVENT-iMICNCT03188770
Practice of Ventilation in Middle-Income Countries
An observational study of Mechanical Ventilation and Respiratory Distress Syndrome, Adult, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 51 sites in 10 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Respiratory Distress Syndrome, Adult, Acute Respiratory Failure
- How many people
- 1,315 participants
- Where
- 51 sitesin 10 countries
- Study dates
- 1 Nov 2017to 29 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive intubated and ventilated intensive care unit patients
Who may be able to join
- Admitted to an ICU participating in this study
- Intubated in the ICU, or in the emergency room, general ward, or operation room before the present ICU admission
Who cannot join
- Age < 18 years
- 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)
Trial locations and contacts
51 sites in 10 countries.
51 sites in 10 countries
Sri Lanka11 sites
Batticaloa Base Hospital
Batticaloa
Colombo South Teaching Hospital MICU
Colombo
Colombo South Teaching Hospital SICU
Colombo
Lanka Hospital
Colombo
National Hospital Sri Lanka MICU
Colombo
National Hospital Sri Lanka SICU
Colombo
Sri Jayawardenepura CTICU
Colombo
Sri Jayewardenepura General Hospital GICU
Colombo
Karapitiya Teaching Hospital
Galle
Jaffna Teaching Hospital
Jaffna
Puttlam Hospital
Puttalam
Pakistan10 sites
Allied Hospital
Faisalābad
PIMS
Islamabad
Shifa International Hospital
Islamabad
Aga Khan University Hospital MICU
Karachi
Aga Khan University SICU
Karachi
Patel Hospital
Karachi
Doctor's Hospital
Lahore
National Hospital and Medical Center
Lahore
Peoples Medical College Hospital
Nawabshah
North West General Hospital
Peshawar
Thailand10 sites
Chulalongkorn University Hospital
Bangkok
Hospital for Tropical Diseases, Mahidol University
Bangkok
Ramathibodi Hospital
Bangkok
Sriraj Hospital
Bangkok
Vajira Hospital
Bangkok
Chiang Mai Hospital Surgical ICU
Chiang Mai
Chiang Mai Medical ICU
Chiang Mai
Nakornping Hospital
Chiang Mai
Prince of Songkla University
Hat Yai
Srinakharinwirot University
Ongkharak
Bangladesh6 sites
Chittagong Medical College Hospital
Chittagong
Bangabandhu Sheikh Mujib Medical University
Dhaka
BIRDEM General Hospital
Dhaka
Dhaka Medical College Hospital
Dhaka
Rajshahi Medical College Hospital
Rajshahi
Sylhet MAG Osmani Medical College Hospital
Sylhet
Malaysia4 sites
Monash University
Johor Bahru
Hospital Kuala Lumpur
Kuala Lumpur
Mohamad Irfan Bin Othman Jailani
Kuala Lumpur
International Islamic University Medical Center
Kuantan
India3 sites
St. John's Medical College
Bangalore
Bharati Vidyapeeth Medical College
Pune
Ispat General Hospital
Raurkela, Odisha
Iran3 sites
Modarres Hospital
Tehran
Pars Hospital
Tehran
Masih Daneshvari Hospital
Tehrān
Vietnam2 sites
National Hospital for Tropical Diseases
Hanoi
Oxford University Clinical Research Unit
Ho Chi Minh City
Maldives1 site
Indira Gandhi Memorial Hospital
Malè
About this study
Official title: PRactice of VENTilation in Critically Ill Patients in Middle-Income Countries (PRoVENT-iMIC) - an International Multicenter Service Review Focusing on ICUs in Asia
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.
Read the detailed description
Rationale: scarce information exists on management of mechanical ventilation in intensive care unit (ICU) patients in low- and middle-income countries.
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.
- Keywords
- Middle-income countries
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Ventilation | Patients under mechanical ventilation in the ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tidal volume size
Tidal volume size in milliliters per kilogram of predicted body weight
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Positive end-expiratory pressure
Pressure in cm of water
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Secondary outcomes (15)
Patients at risk of ARDS
Risk of ARDS is stratified using the Lung Injury Prediction Score.
Measured: On the date of inclusion
Inspired Oxygen Concentration
expressed as fraction of inspired oxygen
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Plateau pressure
Pressure in cm of water
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Peak pressure
Peak away pressure in cm of water
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Driving pressure
pressure in cm of water
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Respiratory Rate
in breaths per minute
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Minute Volume
expressed as liters per minute
Measured: Day 1 to Day 3 from initiation of mechanical ventilation
Development of ARDS
Development of ARDS in patients without ARDS at the onset of mechanical ventilation. Patients are defined as having ARDS if they meet the Berlin criteria for ARDS
Measured: From date of inclusion until the date of first documented development of ARDS or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Worsening of ARDS
Defined as any worsening in the degree of severity according to Berlin criteria.
Measured: From date of inclusion until the date of first documented worsening of ARDS or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Pulmonary infection
defined as need of new antibiotics in the presence of new or changed lung opacities on chest X-ray and/or new or changed sputum plus at least one of the following criteria: 1) temperature > 38.3 ºC; or 2) WBC count > 12,000
Measured: From date of inclusion until the date of first documented pulmonary complication or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Other Pulmonary complications
pneumothorax, pleural effusions, cardiogenic pulmonary edema, new pulmonary infiltrates, and atelectasis
Measured: From date of inclusion until the date of first documented pulmonary complication or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Need for tracheostomy
Need for tracheostomy during ICU stay
Measured: From date of inclusion until the date of first documented tracheostomy procedure or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Length of stay in ICU
Time between admission and discharge or death
Measured: Until day 35 from study initiation
All-cause ICU mortality
Any death during ICU stay
Measured: Until day 35 from study initiation
Duration of mechanical ventilation
time between orotracheal intubation and successful extubation;note: in case of intermittent MV via a tracheostomy, every day a patient needs MV counts as one extra day of MV, irrespective of duration of MV that specific day; in case of non-invasive ventilation (CPAP and/or BIPAP), the duration will be assessed separated from the assessment of invasive mechanical ventilation.
Measured: Until day 35 from study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2017
- Study start1 Nov 2017
- Primary completion29 Nov 2018
- Study completion29 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mechanical VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,315 participants (actual)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Hospital Israelita Albert Einstein
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus J Schultz, MD, PhD, Principal investigator, Department of Intensive Care, Academic Medical Center, University of AmsterdamArjen M Dondorp, MD, PhD, Principal investigator, Mahidol Oxford Research Unit, University of OxfordLuigi Pisani, MD, Study director, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ary Serpa Neto, MD, MSc, Study chair, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03188770
- Sponsor's protocol ID
- PRoVENT-iMIC
- Acronym
- PRoVENT-iMIC
- Status last verified
- Jul 2019
- First submitted
- 12 Jun 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23093163Neto 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.
PubMed 27717861Serafini 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.
PubMed 39961531Serafini 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.
PubMed 38341938Pisani 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.
PubMed 29705765
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRactice of VENTilation in Critically Ill Patients in Middle-Income Countries (PRoVENT-iMIC) - an International Multicenter Service Review Focusing on ICUs in Asia
- ClinicalTrials.gov ID
- NCT03188770
- Acronym / sponsor ID
- PRoVENT-iMIC / PRoVENT-iMIC
- Keywords
- Middle-income countries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,315 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Mahidol Oxford Tropical Medicine Research Unit, Hospital Israelita Albert Einstein
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 29 Nov 2018 (actual)
- Study completion
- 29 Jan 2019 (actual)
- First posted
- 15 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: scarce information exists on management of mechanical ventilation in intensive care unit (ICU) patients in low- and middle-income countries.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mechanical Ventilation | – | –Patients under mechanical ventilation in the ICU |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive intubated and ventilated intensive care unit patients
Key inclusion criteria (2 listed)
- Admitted to an ICU participating in this study
- Intubated in the ICU, or in the emergency room, general ward, or operation room before the present ICU admission
Key exclusion criteria (4 listed)
- Age < 18 years
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tidal volume size
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Tidal volume size in milliliters per kilogram of predicted body weight
Positive end-expiratory pressure
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Pressure in cm of water
15 secondary outcomes
Patients at risk of ARDS
Time frame: On the date of inclusion
Inspired Oxygen Concentration
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Plateau pressure
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Peak pressure
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Driving pressure
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Respiratory Rate
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Minute Volume
Time frame: Day 1 to Day 3 from initiation of mechanical ventilation
Development of ARDS
Time frame: From date of inclusion until the date of first documented development of ARDS or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Worsening of ARDS
Time frame: From date of inclusion until the date of first documented worsening of ARDS or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Pulmonary infection
Time frame: From date of inclusion until the date of first documented pulmonary complication or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Other Pulmonary complications
Time frame: From date of inclusion until the date of first documented pulmonary complication or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Need for tracheostomy
Time frame: From date of inclusion until the date of first documented tracheostomy procedure or date of ICU discharge or death from any cause, whichever came first, assessed up to 7 days
Length of stay in ICU
Time frame: Until day 35 from study initiation
All-cause ICU mortality
Time frame: Until day 35 from study initiation
Duration of mechanical ventilation
Time frame: Until day 35 from study initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Background: PubMed 23093163Serpa 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.
- Results publication: PubMed 27717861Neto 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.
- Derived from this study: PubMed 39961531Serafini 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.
- Derived from this study: PubMed 38341938Serafini 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.
- Derived from this study: PubMed 29705765Pisani 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.
- Study websiteLink provided by the sponsor.
- Protective Ventilation Network websiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus J Schultz, MD, PhD principal investigator
Department of Intensive Care, Academic Medical Center, University of Amsterdam
Arjen M Dondorp, MD, PhD principal investigator
Mahidol Oxford Research Unit, University of Oxford
Luigi Pisani, MD study director
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
51 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation and Respiratory Distress Syndrome, Adult, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 51 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in Sri Lanka, Pakistan, Thailand, Bangladesh, Malaysia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tidal volume size (time frame: Day 1 to Day 3 from initiation of mechanical ventilation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03188770, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.