Practice of Ventilation in Critically Ill Patients Without ARDS

NCT01868321 | Completed

• 1 other identifier: PRoVENT
• Study Type: observational
• Target: 1,030
• Locations: 9 countries
• Sites: 13

Brief Summary

The purpose of this international, multicenter study is to determine ventilation practice and outcomes of intubated and ventilated intensive care unit (ICU) patients. Ventilation characteristics and outcomes will be compared between patients without the acute respiratory distress syndrome (ARDS), patients at risk for ARDS, and patients with mild, moderate or severe ARDS. Participating centres worldwide will include adult patients undergoing mechanical ventilation in the ICU during a 7-day period. Patients data will be collected during the first 7 days in the ICU, or until ICU discharge. Follow up is until day 90. Primary endpoint is the tidal volume size used during mechanical ventilation. 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, extra-pulmonary complications, duration of ventilation, length of ICU and hospital stay, and ICU, hospital and 90-day mortality.

Conditions

Mechanical Ventilation

Keywords

Mechanical ventilation; Acute respiratory failure; Acute respiratory distress syndrome

Outcome Measures

Primary Outcomes (1)

• Tidal Volume Size

  Tidal volume size in milliliters per kilogram of predicted body weight

  During mechanical ventilation

Secondary Outcomes (12)

• Other Ventilation Parameters

  During mechanical ventilation

• Development of ARDS

  From date of inclusion until the date of first documented ARDS or date of hospital discharge or death from any cause, whichever came first, assessed up to three months

• Worsening of ARDS

  From date of inclusion until the date of first documented worsening of ARDS or date of hospital discharge or death from any cause, whichever came first, assessed up to three months

• Other Pulmonary Complications

  From date of inclusion until the date of first documented pulmonary complication or date of hospital discharge or death from any cause, whichever came first, assessed up to three months

• Pulmonary Infection

  From date of inclusion until the date of first documented pulmonary infection or date of hospital discharge or death from any cause, whichever came first, assessed up to three months

Study Arms (1)

Mechanical Ventilation

Patients under mechanical ventilation in the ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Intubated and ventilated ICU-patients.

You may qualify if:

• Admitted to a participating ICU
• Intubated in the participating ICU, or in the emergency room or operation room before the present ICU admission

You may not qualify if:

• Age \< 18 years
• Receiving only non-invasive ventilation
• Patients transferred from another hospital under invasive mechanical ventilation

Sponsors & Collaborators

• Prof. Dr. Marcus J. Schultz: lead
• European Society of Anaesthesiology: collaborator

Study Sites (13)

Medical University Viena

Vienna, Austria

Location

University Hospital Leuven

Leuven, Belgium

Location

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Location

Hospital Clínico de la Pontificia Universidad Católica de Chile

Santiago, Chile

Location

Saint Eloi University Hospital

Montpellier, France

Location

University Hospital Bonn

Bonn, Germany

Location

University Clinic Carl Gustav Carus

Dresden, Germany

Location

University of Leipzig

Leipzig, Germany

Location

University of Genoa

Genoa, Italy

Location

University of Insubria

Varese, Italy

Location

Academic Medical Centre

Amsterdam, Netherlands

Location

Hospital Universitari Germans Trias I Pujol

Barcelona, Spain

Location

Related Publications (9)

• Hemmes SN, Serpa Neto A, Schultz MJ. Intraoperative ventilatory strategies to prevent postoperative pulmonary complications: a meta-analysis. Curr Opin Anaesthesiol. 2013 Apr;26(2):126-33. doi: 10.1097/ACO.0b013e32835e1242.

  PMID: 23385321 BACKGROUND

• 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.

  PMID: 23093163 BACKGROUND

• Determann RM, Royakkers A, Wolthuis EK, Vlaar AP, Choi G, Paulus F, Hofstra JJ, de Graaff MJ, Korevaar JC, Schultz MJ. Ventilation with lower tidal volumes as compared with conventional tidal volumes for patients without acute lung injury: a preventive randomized controlled trial. Crit Care. 2010;14(1):R1. doi: 10.1186/cc8230. Epub 2010 Jan 7.

  PMID: 20055989 BACKGROUND

• Severgnini P, Selmo G, Lanza C, Chiesa A, Frigerio A, Bacuzzi A, Dionigi G, Novario R, Gregoretti C, de Abreu MG, Schultz MJ, Jaber S, Futier E, Chiaranda M, Pelosi P. Protective mechanical ventilation during general anesthesia for open abdominal surgery improves postoperative pulmonary function. Anesthesiology. 2013 Jun;118(6):1307-21. doi: 10.1097/ALN.0b013e31829102de.

  PMID: 23542800 BACKGROUND

• Serpa Neto A, Barbas CSV, Artigas A, et al. Rationale and Study Design of Provent-An International Multicenter Observational Study on Practice of Ventilation in Critically Ill Patients without ARDS. J Clin Trials 2013;3;[in press]

  BACKGROUND

• 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.

  PMID: 39961531 DERIVED

• 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.

  PMID: 38341938 DERIVED

• Simonis FD, Barbas CSV, 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, Vidal Melo MF, Wrigge H, de Abreu MG, Pelosi P, Schultz MJ, Neto AS; PRoVENT investigators; PROVE Network investigators. Potentially modifiable respiratory variables contributing to outcome in ICU patients without ARDS: a secondary analysis of PRoVENT. Ann Intensive Care. 2018 Mar 21;8(1):39. doi: 10.1186/s13613-018-0385-7.

  PMID: 29564726 DERIVED

• 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.

  PMID: 27717861 DERIVED

Related Links

• PRoVENT website

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Marcus J Schultz, MD, PhD

  Department of Intensive Care, Academic Medical Center, University of Amsterdam

  STUDY CHAIR

• Ary Serpa Neto, MD, MSc

  PRoVENT Study Trial Coordinator, Department of Intensive Care, Academic Medical Center, University of Amsterdam

  STUDY DIRECTOR

• Paolo Pelosi, MD, PhD

  Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy

  PRINCIPAL INVESTIGATOR

• Marcelo Gama de Abreu, MD, PhD

  Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

  PRINCIPAL INVESTIGATOR

• Carmen SV Barbas, MD, PhD

  Department of Intensive Care, Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 4, 2013
• Study Start: April 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: April 28, 2015

Record last verified: 2015-04

Locations

DE (3); ES (1); FR (1); AU (1); IT (2); CL (1); BE (1); NL (1); BR (2)