All Centres Willing to Contribute Are Welcome
Brussels, Belgium
NCT Number: NCT02010073
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.
Looking for future studies?
Notify Me16 year and older
All sexes
Observational
Brussels, Belgium
In summary, the study will focus on the following items:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 28 days
Time frame: 28 days
European Society of Intensive Care Medicine
Other
A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
Acronym: LUNG-SAFE
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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