An observational study in Acute Severe Respiratory Failure and Acute Respiratory Distress Syndrome, sponsored by European Society of Intensive Care Medicine. Completed at 1 site in Belgium. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2014-12-11.
Sponsored by European Society of Intensive Care Medicine · Observational
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:
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.
In summary, the study will focus on the following items:
Therapeutic resource utilization
This is a prospective observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs.
ICUs will be invited to participate on a voluntary basis. ICUs enrolling into existing databases (e.g., ERIC study, ICON audit) will be invited to participate. It is important that participating ICUs commit (by written agreement) to fully comply with the study protocol. ICU recruitment in each country will be spearheaded by a national coordinator Each ICU will be requested to recruit for 4 consecutive 'winter' weeks
INCLUSION CRITERIA: All patients admitted to the participating ICUs receiving invasive or noninvasive ventilation will be screened and included in the database.
EXCLUSION CRITERIA: Age \< 16.
DATA COLLECTION: Data collection will web based, permitting conditional Data Collection screens, i.e. data collectors will be automatically guided as to which sections to complete based on data entered indicating whether Inclusion Criteria are met. Data collection will be done at 10am each morning. Our aim is to obtain a sample of at least 1000 ARDS patients within the cohort of patients receiving assisted ventilation. The reported incidence of ARDS in ICU patients varies, from 2.2% of ICU admissions develop ARDS in ALIEN, 7.1% in ALIVE Study, to 17.5% of Ventilated patients in KCLIP . A reasonable projection of the incidence of ARDS among patients admitted in ICUs can be estimated to approximate 5% of ICU admission. As a conservative estimate, if a medium-sized ICU admits 50 patients/month and collects data for four, 500 ICUs will be necessary to achieve this number.
1,387 studies on the registry are indexed under Respiratory Distress Syndrome; 283 are open to participants now.
This study's enrollment of 14,000 is above the median of 100 across 475 observational studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →European Society of Intensive Care Medicine is the lead sponsor of 10 studies on the registry; none are open to participants now.
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Our aim is to obtain a sample of at least 1000 ARDS patients within the cohort of patients receiving assisted ventilation.
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Exclusion Criteria:
This is a prospective observational study, aimed at collecting an adequate dataset on a large cohort of patients admitted to a large number of ICUs.
Development of ARDS
Time frame: 28 days
ICU mortality
Time frame: 28 days
This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome →
European Society of Intensive Care Medicine