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Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE (LUNG-SAFE)

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ClinicalTrials.gov Identifier: NCT02010073
Recruitment Status : Completed
First Posted : December 12, 2013
Last Update Posted : December 11, 2014
Sponsor:
Information provided by (Responsible Party):
European Society of Intensive Care Medicine

Brief 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.


Condition or disease
Acute Severe Respiratory Failure Acute Respiratory Distress Syndrome

Detailed Description:

In summary, the study will focus on the following items:

  • The frequency and disease burden of acute hypoxaemic respiratory failure in winter
  • The aetiologies of acute hypoxaemic respiratory failure requiring ventilatory support.
  • The incidence of ARDS based on the Berlin definition within this patient cohort
  • The mortality from ARDS within this cohort, and how does this vary based on ARDS severity
  • Natural history of ARDS (duration and evolution by severity)
  • Therapeutic resource utilization

    • Use of treatments, such as recruitment maneuvers, prone positioning, nitric oxide, high frequency oscillation, ECMO, transfer to tertiary hospital from smaller regional ones) according to the severity of the disease
    • Use of non-invasive ventilation in management of ARDS patients (use in different stages: early ARDS versus immediately after extubation).

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

  1. Northern Hemisphere - 4 week period between February 1st and March 31st 2014.
  2. Southern Hemisphere: 4 week period between June 1st - August 31st 2014 There will be 2 data collectors per participating ICU's. Each data collector will undergo an online training program designed to standardize data interpretation [esp. CXR's] and will receive a login authorization following completion of this training.

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.


Study Type : Observational
Actual Enrollment : 14000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
Study Start Date : February 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 2014


Group/Cohort
One Group
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.



Primary Outcome Measures :
  1. Development of ARDS [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. ICU mortality [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Our aim is to obtain a sample of at least 1000 ARDS patients within the cohort of patients receiving assisted ventilation.
Criteria

Inclusion Criteria:

  • All patients admitted to the participating ICUs receiving invasive or non-invasive ventilation will be screened and included in the database.

Exclusion Criteria:

  • Age < 16

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02010073


Locations
Belgium
All Centres Willing to Contribute Are Welcome
Brussels, Belgium
Sponsors and Collaborators
European Society of Intensive Care Medicine
Investigators
Principal Investigator: John LAFFEY, MD National University of Galway, Ireland and St Michael's Hospital-University of Toronto, Canada
Principal Investigator: Antonio PESENTI, MD S Gerardo Hospital, University of Milan-Bicocca, Monza, Italy

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: European Society of Intensive Care Medicine
ClinicalTrials.gov Identifier: NCT02010073     History of Changes
Other Study ID Numbers: LUNG-SAFE
First Posted: December 12, 2013    Key Record Dates
Last Update Posted: December 11, 2014
Last Verified: December 2014

Keywords provided by European Society of Intensive Care Medicine:
Lung
ARDS
acute
respiratory
syndrome
prognosis
outcome research
respiratory infection
sepsis
organ failure
hypoxaemia

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury