CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14,000 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Search/NCT02010073
NCT02010073N/ACompleted

A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM

European Society of Intensive Care Medicine·observational·Posted Dec 12, 2013·Updated Dec 11, 2014

In Brief

An observational study for Acute Severe Respiratory Failure and Acute Respiratory Distress Syndrome. Completed, enrolled 14,000 participants across 1 site.

Detailed Summary

We wish to prospectively assess the burden of, management and therapeutic approaches to, and outcomes from acute hypoxaemic respiratory failure requiring ventilatory support, during the winter months in both the northern and southern hemispheres. We wish to specifically examine the contribution of ARDS as defined by the Berlin Definition to the burden of hypoxaemic respiratory failure. Why? The purpose of this study is to provide new and current data on the disease burden of acute hypoxemic respiratory failure and ARDS. It will answer the following questions: * What is the frequency and disease burden of acute hypoxaemic respiratory failure in winter? * What are the aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support? * What is the incidence of ARDS based on the Berlin definition within this patient cohort? * What is the mortality from ARDS within this cohort, and how does this vary based on ARDS severity? * What is the natural history of ARDS? * What are the key patterns of therapeutic resource utilization, particularly approaches to sustain gas exchange, in these patients? When? The study is performed over a 4 week period between February 1st and March 31st 2014 in the Northern Hemisphere and June 1st to August 31st in the Southern Hemisphere. What data is required? A basic dataset is collected on all patients admitted with acute acute hypoxaemic respiratory failure requiring ventilatory support, with a more detailed dataset collected on patients diagnosed with ARDS.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesBelgium
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 12, 2013
Enrollment StartFeb 1, 2014
Primary CompletionAug 1, 2014
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 12.6 years ago