MedTrace Logo

Practice of Ventilation in Critically Ill Patients Without ARDS

NCT01868321 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1030

Last updated 2015-04-28

No results posted yet for this study

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

Sponsors & Collaborators

  • European Society of Anaesthesiology

    collaborator OTHER

  • Prof. Dr. Marcus J. Schultz

    lead OTHER

Principal Investigators

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

  • Ary Serpa Neto, MD, MSc · PRoVENT Study Trial Coordinator, Department of Intensive Care, Academic Medical Center, University of Amsterdam

  • Paolo Pelosi, MD, PhD · Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Italy

  • Marcelo Gama de Abreu, MD, PhD · Department of Anesthesiology and Intensive Care Medicine, University Hospital Carl Gustav Carus, Technical University Dresden, Germany

  • Carmen SV Barbas, MD, PhD · Department of Intensive Care, Hospital Israelita Albert Einstein

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Austria
  • Belgium
  • Brazil
  • Chile
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

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 NCT01868321 on ClinicalTrials.gov