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Practice of Ventilation in Middle-Income Countries

NCT03188770 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1315

Last updated 2019-07-05

No results posted yet for this study

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.

Conditions

  • Mechanical Ventilation
  • Respiratory Distress Syndrome, Adult
  • Acute Respiratory Failure

Sponsors & Collaborators

  • Mahidol Oxford Tropical Medicine Research Unit

    collaborator OTHER

  • Hospital Israelita Albert Einstein

    collaborator OTHER

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Marcus J Schultz, MD, PhD · Department of Intensive Care, Academic Medical Center, University of Amsterdam

  • Arjen M Dondorp, MD, PhD · Mahidol Oxford Research Unit, University of Oxford

  • Luigi Pisani, MD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  • Ary Serpa Neto, MD, MSc · Hospital Israelita Albert Einstein

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2018-11-29
Completion
2019-01-29

Countries

  • Bangladesh
  • India
  • Iran
  • Malaysia
  • Maldives
  • Nepal
  • Pakistan
  • Sri Lanka
  • Thailand
  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03188770 on ClinicalTrials.gov