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Practice of Ventilation in Middle-Income Countries (PRoVENT-iMIC)

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ClinicalTrials.gov Identifier: NCT03188770
Recruitment Status : Completed
First Posted : June 15, 2017
Last Update Posted : July 3, 2019
Sponsor:
Collaborators:
Mahidol Oxford Tropical Medicine Research Unit
Hospital Israelita Albert Einstein
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 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.


Condition or disease
Mechanical Ventilation Respiratory Distress Syndrome, Adult Acute Respiratory Failure

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 1315 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : November 1, 2017
Actual Primary Completion Date : November 29, 2018
Actual Study Completion Date : January 29, 2019


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



Primary Outcome Measures :
  1. 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

  2. Positive end-expiratory pressure [ Time Frame: Day 1 to Day 3 from initiation of mechanical ventilation ]
    Pressure in cm of water


Secondary Outcome Measures :
  1. Patients at risk of ARDS [ Time Frame: On the date of inclusion ]
    Risk of ARDS is stratified using the Lung Injury Prediction Score.

  2. Inspired Oxygen Concentration [ Time Frame: Day 1 to Day 3 from initiation of mechanical ventilation ]
    expressed as fraction of inspired oxygen

  3. Plateau pressure [ Time Frame: Day 1 to Day 3 from initiation of mechanical ventilation ]
    Pressure in cm of water

  4. Peak pressure [ Time Frame: Day 1 to Day 3 from initiation of mechanical ventilation ]
    Peak away pressure in cm of water

  5. Driving pressure [ Time Frame: Day 1 to Day 3 from initiation of mechanical ventilation ]
    pressure in cm of water

  6. Respiratory Rate [ Time Frame: Day 1 to Day 3 from initiation of mechanical ventilation ]
    in breaths per minute

  7. Minute Volume [ Time Frame: Day 1 to Day 3 from initiation of mechanical ventilation ]
    expressed as liters per minute

  8. 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 ]
    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

  9. 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 ]
    Defined as any worsening in the degree of severity according to Berlin criteria.

  10. 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 ]
    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

  11. 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 ]
    pneumothorax, pleural effusions, cardiogenic pulmonary edema, new pulmonary infiltrates, and atelectasis

  12. 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 ]
    Need for tracheostomy during ICU stay

  13. Length of stay in ICU [ Time Frame: Until day 35 from study initiation ]
    Time between admission and discharge or death

  14. All-cause ICU mortality [ Time Frame: Until day 35 from study initiation ]
    Any death during ICU stay

  15. Duration of mechanical ventilation [ Time Frame: Until day 35 from study initiation ]
    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.



Information from the National Library of Medicine

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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
consecutive intubated and ventilated intensive care unit patients
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)

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): NCT03188770


  Show 51 Study Locations
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Mahidol Oxford Tropical Medicine Research Unit
Hospital Israelita Albert Einstein
Investigators
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Principal Investigator: Marcus J Schultz, MD, PhD Department of Intensive Care, Academic Medical Center, University of Amsterdam
Principal Investigator: Arjen M Dondorp, MD, PhD Mahidol Oxford Research Unit, University of Oxford
Study Director: Luigi Pisani, MD Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Study Chair: Ary Serpa Neto, MD, MSc Hospital Israelita Albert Einstein
  Study Documents (Full-Text)

Documents provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Statistical Analysis Plan  [PDF] December 20, 2018


Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Marcus J. Schultz, Prof., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03188770     History of Changes
Other Study ID Numbers: PRoVENT-iMIC
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
Middle-income countries
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury