CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,030 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01868321
NCT01868321N/ACompleted

Practice of Ventilation in Critically Ill Patients Without Acute Respiratory Distress Syndrome - An International Observational Study

Prof. Dr. Marcus J. Schultz·observational·Posted Jun 4, 2013·Updated Apr 28, 2015

In Brief

An observational study for Mechanical Ventilation. Completed, enrolled 1,030 participants across 13 sites in 9 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Belgium, Brazil, Chile, France, Germany, Italy, Netherlands, Spain

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJun 4, 2013
Enrollment StartApr 1, 2014
Primary CompletionMar 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 13.1 years ago