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

December 10, 2014 updated by: European Society of Intensive Care Medicine

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

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 Overview

Status

Completed

Conditions

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

Enrollment (Actual)

14000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • All Centres Willing to Contribute Are Welcome

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of ARDS
Time Frame: 28 days
28 days

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU mortality
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

November 28, 2013

First Submitted That Met QC Criteria

December 9, 2013

First Posted (Estimate)

December 12, 2013

Study Record Updates

Last Update Posted (Estimate)

December 11, 2014

Last Update Submitted That Met QC Criteria

December 10, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LUNG-SAFE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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