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Practice of Ventilation in Critically Ill Patients Without ARDS (PRoVENT)

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ClinicalTrials.gov Identifier: NCT01868321
Recruitment Status : Completed
First Posted : June 4, 2013
Last Update Posted : April 28, 2015
Sponsor:
Collaborator:
European Society of Anaesthesiology
Information provided by (Responsible Party):
Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.


Condition or disease
Mechanical Ventilation

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Study Type : Observational
Actual Enrollment : 1030 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Practice of Ventilation in Critically Ill Patients Without Acute Respiratory Distress Syndrome - An International Observational Study
Study Start Date : April 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015


Group/Cohort
Mechanical Ventilation
Patients under mechanical ventilation in the ICU



Primary Outcome Measures :
  1. Tidal Volume Size [ Time Frame: During mechanical ventilation ]
    Tidal volume size in milliliters per kilogram of predicted body weight


Secondary Outcome Measures :
  1. Other Ventilation Parameters [ Time Frame: During mechanical ventilation ]
    Plateau and peak pressure, positive end-expiratory pressure, driving pressure, respiratory rate, inspired oxygen fraction, inspiration to expiration ratio, and minute volume

  2. Development of ARDS [ Time Frame: 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 ]
    Patients are defined as having ARDS if they met the Berlin criteria for ARDS.

  3. Worsening of ARDS [ Time Frame: 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 ]
    Defined as any worse in the degree of severity according to Berlin criteria.

  4. Other Pulmonary Complications [ Time Frame: 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 ]
    Atelectasis, barotrauma, pleural effusion

  5. Pulmonary Infection [ Time Frame: 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 ]
    Defined as need of new antibiotics plus at least one of the following criteria: 1) new or changed sputum; 2) new or changed lung opacities on chest X-ray; 3) temperature > 38.3 ºC; or 4) WBC count > 12,000.

  6. Need for Tracheostomy [ Time Frame: From date of inclusion until the date of first documented tracheostomy or date of hospital discharge or death from any cause, whichever came first, assessed up to three months ]
    Need for tracheostomy during hospital stay

  7. Extra-Pulmonary Complications [ Time Frame: From date of inclusion until the date of first documented extra-pulmonary complication or date of hospital discharge or death from any cause, whichever came first, assessed up to three months ]
    Acute kidney injury, circulatory failure, gastrointestinal failure, acute or exacerbation of chronic heart failure, liver failure, and delirium.

  8. Duration of Mechanical Ventilation [ Time Frame: During 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 MV, every day a patient needs non-invasive MV counts as one extra day of MV, irrespective of duration of non-invasive MV that specific day.

  9. Length of Stay in ICU on Day 90 [ Time Frame: Until day 90 ]
    Time between admission and discharge or death

  10. Length of Stay in Hospital on Day 90 [ Time Frame: Until day 90 ]
    Time between admission and discharge or death

  11. All-cause ICU Mortality [ Time Frame: Until day 90 ]
    Any death during ICU stay

  12. All-cause Hospital Mortality [ Time Frame: Until day 90 ]
    Any death during hospital stay



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Intubated and ventilated ICU-patients.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Age < 18 years
  • Receiving only non-invasive ventilation
  • Patients under invasive mechanical ventilation previous to the 7-day period of inclusion
  • Patients transferred from another hospital under invasive mechanical ventilation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01868321


Locations
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Austria
Medical University Viena
Vienna, Austria
Belgium
University Hospital Leuven
Leuven, Belgium
Brazil
Hospital Israelita Albert Einstein
São Paulo, SP, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Chile
Hospital Clínico de la Pontificia Universidad Católica de Chile
Santiago, Chile
France
Saint Eloi University Hospital
Montpellier, France
Germany
University Hospital Bonn
Bonn, Germany
University Clinic Carl Gustav Carus
Dresden, Germany
University of Leipzig
Leipzig, Germany
Italy
University of Genoa
Genoa, Italy
University of Insubria
Varese, Italy
Netherlands
Academic Medical Centre
Amsterdam, Netherlands
Spain
Hospital Universitari Germans Trias I Pujol
Barcelona, Spain
Sponsors and Collaborators
Prof. Dr. Marcus J. Schultz
European Society of Anaesthesiology
Investigators
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Study Chair: Marcus J Schultz, MD, PhD Department of Intensive Care, Academic Medical Center, University of Amsterdam
Study Director: Ary Serpa Neto, MD, MSc PRoVENT Study Trial Coordinator, Department of Intensive Care, Academic Medical Center, University of Amsterdam
Principal Investigator: 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
Additional Information:
Publications:
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]

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Marcus J. Schultz, Prof. Dr., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT01868321    
Other Study ID Numbers: PRoVENT
First Posted: June 4, 2013    Key Record Dates
Last Update Posted: April 28, 2015
Last Verified: April 2015
Keywords provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Mechanical ventilation
Acute respiratory failure
Acute respiratory distress syndrome