Acute Severe Respiratory FailureLUNG-SAFENCT02010073
Large Observational Study to UNderstand the Global Impact of Severe Acute Respiratory FailurE
An observational study of Acute Severe Respiratory Failure and Acute Respiratory Distress Syndrome, run by European Society of Intensive Care Medicine at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acute Severe Respiratory Failure, Acute Respiratory Distress Syndrome
- How many people
- 14,000 participants
- Where
- 1 siteBelgium
- Study dates
- Feb 2014to Sep 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Our aim is to obtain a sample of at least 1000 ARDS patients within the cohort of patients receiving assisted ventilation.
Who may be able to join
- All patients admitted to the participating ICUs receiving invasive or non-invasive ventilation will be screened and included in the database.
Who cannot join
- Age < 16
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the 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
- Northern Hemisphere - 4 week period between February 1st and March 31st 2014.
- 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.
- Keywords
- Lung, ARDS, acute, respiratory, syndrome, prognosis, outcome research, respiratory infection, sepsis, organ failure, hypoxaemia
- Medical subject headings
- Respiratory Distress Syndrome, Syndrome, Respiratory Tract Infections, Sepsis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Development of ARDS
Measured: 28 days
Secondary outcomes (1)
ICU mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionAug 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Acute Severe Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 14,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Society of Intensive Care Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John LAFFEY, MD, Principal investigator, National University of Galway, Ireland and St Michael's Hospital-University of Toronto, CanadaAntonio PESENTI, MD, Principal investigator, S Gerardo Hospital, University of Milan-Bicocca, Monza, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010073
- Sponsor's protocol ID
- LUNG-SAFE
- Acronym
- LUNG-SAFE
- Status last verified
- Dec 2014
- First submitted
- 28 Nov 2013
- Last updated
- 11 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Serafini SC, van Meenen DMP, Pisani L, Neto AS, Ball L, de Abreu MG, Algera AG, Azevedo L, Bellani G, Dondorp AM, Fan E, Laffey JG, Pham T, Tschernko EM, Schultz MJ, van der Woude MCE; ERICC; LUNG SAFE; PRoVENT; PRoVENT-iMiC-investigators. Different ventilation intensities among various categories of patients ventilated for reasons other than ARDS--A pooled analysis of 4 observational studies. J Crit Care. 2024 Jun;81:154531. doi: 10.1016/j.jcrc.2024.154531. Epub 2024 Feb 10.
PubMed 38341938Amado-Rodriguez L, Rodriguez-Garcia R, Bellani G, Pham T, Fan E, Madotto F, Laffey JG, Albaiceta GM; LUNG SAFE investigators. Mechanical ventilation in patients with cardiogenic pulmonary edema: a sub-analysis of the LUNG SAFE study. J Intensive Care. 2022 Dec 25;10(1):55. doi: 10.1186/s40560-022-00648-x.
PubMed 36567347Rezoagli E, McNicholas BA, Madotto F, Pham T, Bellani G, Laffey JG; LUNG SAFE Investigators, the ESICM Trials Group. Presence of comorbidities alters management and worsens outcome of patients with acute respiratory distress syndrome: insights from the LUNG SAFE study. Ann Intensive Care. 2022 May 21;12(1):42. doi: 10.1186/s13613-022-01015-7.
PubMed 35596885Madotto F, McNicholas B, Rezoagli E, Pham T, Laffey JG, Bellani G; LUNG SAFE Investigators; ESICM Trials Group. Death in hospital following ICU discharge: insights from the LUNG SAFE study. Crit Care. 2021 Apr 13;25(1):144. doi: 10.1186/s13054-021-03465-0.
PubMed 33849625Pham T, Pesenti A, Bellani G, Rubenfeld G, Fan E, Bugedo G, Lorente JA, Fernandes ADV, Van Haren F, Bruhn A, Rios F, Esteban A, Gattinoni L, Larsson A, McAuley DF, Ranieri M, Thompson BT, Wrigge H, Brochard LJ, Laffey JG; LUNG SAFE Investigators and the European Society of Intensive Care Medicine Trials Group. Outcome of acute hypoxaemic respiratory failure: insights from the LUNG SAFE Study. Eur Respir J. 2021 Jun 10;57(6):2003317. doi: 10.1183/13993003.03317-2020. Print 2021 Jun.
PubMed 33334944Madotto F, Rezoagli E, Pham T, Schmidt M, McNicholas B, Protti A, Panwar R, Bellani G, Fan E, van Haren F, Brochard L, Laffey JG; LUNG SAFE Investigators and the ESICM Trials Group. Hyperoxemia and excess oxygen use in early acute respiratory distress syndrome: insights from the LUNG SAFE study. Crit Care. 2020 Mar 31;24(1):125. doi: 10.1186/s13054-020-2826-6.
PubMed 32234077Duggal A, Rezoagli E, Pham T, McNicholas BA, Fan E, Bellani G, Rubenfeld G, Pesenti AM, Laffey JG; LUNG SAFE Investigators and the ESICM Trials Group. Patterns of Use of Adjunctive Therapies in Patients With Early Moderate to Severe ARDS: Insights From the LUNG SAFE Study. Chest. 2020 Jun;157(6):1497-1505. doi: 10.1016/j.chest.2020.01.041. Epub 2020 Feb 20.
PubMed 32088180Boyle AJ, Madotto F, Laffey JG, Bellani G, Pham T, Pesenti A, Thompson BT, O'Kane CM, Deane AM, McAuley DF; LUNG SAFE Investigators; ESICM Trials Group. Identifying associations between diabetes and acute respiratory distress syndrome in patients with acute hypoxemic respiratory failure: an analysis of the LUNG SAFE database. Crit Care. 2018 Oct 27;22(1):268. doi: 10.1186/s13054-018-2158-y.
PubMed 30367670Abe T, Madotto F, Pham T, Nagata I, Uchida M, Tamiya N, Kurahashi K, Bellani G, Laffey JG; LUNG-SAFE Investigators and the ESICM Trials Group. Epidemiology and patterns of tracheostomy practice in patients with acute respiratory distress syndrome in ICUs across 50 countries. Crit Care. 2018 Aug 17;22(1):195. doi: 10.1186/s13054-018-2126-6.
PubMed 30115127Cortegiani A, Madotto F, Gregoretti C, Bellani G, Laffey JG, Pham T, Van Haren F, Giarratano A, Antonelli M, Pesenti A, Grasselli G; LUNG SAFE Investigators and the ESICM Trials Group. Immunocompromised patients with acute respiratory distress syndrome: secondary analysis of the LUNG SAFE database. Crit Care. 2018 Jun 12;22(1):157. doi: 10.1186/s13054-018-2079-9.
PubMed 29895331Madotto F, Pham T, Bellani G, Bos LD, Simonis FD, Fan E, Artigas A, Brochard L, Schultz MJ, Laffey JG; LUNG SAFE Investigators and the ESICM Trials Group. Resolved versus confirmed ARDS after 24 h: insights from the LUNG SAFE study. Intensive Care Med. 2018 May;44(5):564-577. doi: 10.1007/s00134-018-5152-6. Epub 2018 Apr 9.
PubMed 29632996de Prost N, Pham T, Carteaux G, Mekontso Dessap A, Brun-Buisson C, Fan E, Bellani G, Laffey J, Mercat A, Brochard L, Maitre B; LUNG SAFE investigators; ESICM trials group; REVA network. Etiologies, diagnostic work-up and outcomes of acute respiratory distress syndrome with no common risk factor: a prospective multicenter study. Ann Intensive Care. 2017 Dec;7(1):69. doi: 10.1186/s13613-017-0281-6. Epub 2017 Jun 19.
PubMed 28631088Laffey JG, Madotto F, Bellani G, Pham T, Fan E, Brochard L, Amin P, Arabi Y, Bajwa EK, Bruhn A, Cerny V, Clarkson K, Heunks L, Kurahashi K, Laake JH, Lorente JA, McNamee L, Nin N, Palo JE, Piquilloud L, Qiu H, Jimenez JIS, Esteban A, McAuley DF, van Haren F, Ranieri M, Rubenfeld G, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Geo-economic variations in epidemiology, patterns of care, and outcomes in patients with acute respiratory distress syndrome: insights from the LUNG SAFE prospective cohort study. Lancet Respir Med. 2017 Aug;5(8):627-638. doi: 10.1016/S2213-2600(17)30213-8. Epub 2017 Jun 15.
PubMed 28624388Laffey JG, Bellani G, Pham T, Fan E, Madotto F, Bajwa EK, Brochard L, Clarkson K, Esteban A, Gattinoni L, van Haren F, Heunks LM, Kurahashi K, Laake JH, Larsson A, McAuley DF, McNamee L, Nin N, Qiu H, Ranieri M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators and the ESICM Trials Group. Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study. Intensive Care Med. 2016 Dec;42(12):1865-1876. doi: 10.1007/s00134-016-4571-5. Epub 2016 Oct 18.
PubMed 27757516Bellani G, Laffey JG, Pham T, Fan E, Brochard L, Esteban A, Gattinoni L, van Haren F, Larsson A, McAuley DF, Ranieri M, Rubenfeld G, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Epidemiology, Patterns of Care, and Mortality for Patients With Acute Respiratory Distress Syndrome in Intensive Care Units in 50 Countries. JAMA. 2016 Feb 23;315(8):788-800. doi: 10.1001/jama.2016.0291.
PubMed 26903337
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective, Observational, 4-week Inception Cohort Study Being Carried Out by the Acute Respiratory Failure Section of ESICM
- ClinicalTrials.gov ID
- NCT02010073
- Acronym / sponsor ID
- LUNG-SAFE / LUNG-SAFE
- Keywords
- Lung, ARDS, acute, respiratory, syndrome, prognosis, outcome research, respiratory infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14,000 participants (actual)
- Lead sponsor
- European Society of Intensive Care MedicineUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Northern Hemisphere - 4 week period between February 1st and March 31st 2014.
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Our aim is to obtain a sample of at least 1000 ARDS patients within the cohort of patients receiving assisted ventilation.
Key inclusion criteria (1 listed)
- All patients admitted to the participating ICUs receiving invasive or non-invasive ventilation will be screened and included in the database.
Key exclusion criteria (1 listed)
- Age < 16
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Development of ARDS
Time frame: 28 days
1 secondary outcome
ICU mortality
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2014.
- Derived from this study: PubMed 38341938Serafini SC, van Meenen DMP, Pisani L, Neto AS, Ball L, de Abreu MG, Algera AG, Azevedo L, Bellani G, Dondorp AM, Fan E, Laffey JG, Pham T, Tschernko EM, Schultz MJ, van der Woude MCE; ERICC; LUNG SAFE; PRoVENT; PRoVENT-iMiC-investigators. Different ventilation intensities among various categories of patients ventilated for reasons other than ARDS--A pooled analysis of 4 observational studies. J Crit Care. 2024 Jun;81:154531. doi: 10.1016/j.jcrc.2024.154531. Epub 2024 Feb 10.
- Derived from this study: PubMed 36567347Amado-Rodriguez L, Rodriguez-Garcia R, Bellani G, Pham T, Fan E, Madotto F, Laffey JG, Albaiceta GM; LUNG SAFE investigators. Mechanical ventilation in patients with cardiogenic pulmonary edema: a sub-analysis of the LUNG SAFE study. J Intensive Care. 2022 Dec 25;10(1):55. doi: 10.1186/s40560-022-00648-x.
- Derived from this study: PubMed 35596885Rezoagli E, McNicholas BA, Madotto F, Pham T, Bellani G, Laffey JG; LUNG SAFE Investigators, the ESICM Trials Group. Presence of comorbidities alters management and worsens outcome of patients with acute respiratory distress syndrome: insights from the LUNG SAFE study. Ann Intensive Care. 2022 May 21;12(1):42. doi: 10.1186/s13613-022-01015-7.
- Derived from this study: PubMed 33849625Madotto F, McNicholas B, Rezoagli E, Pham T, Laffey JG, Bellani G; LUNG SAFE Investigators; ESICM Trials Group. Death in hospital following ICU discharge: insights from the LUNG SAFE study. Crit Care. 2021 Apr 13;25(1):144. doi: 10.1186/s13054-021-03465-0.
- Derived from this study: PubMed 33334944Pham T, Pesenti A, Bellani G, Rubenfeld G, Fan E, Bugedo G, Lorente JA, Fernandes ADV, Van Haren F, Bruhn A, Rios F, Esteban A, Gattinoni L, Larsson A, McAuley DF, Ranieri M, Thompson BT, Wrigge H, Brochard LJ, Laffey JG; LUNG SAFE Investigators and the European Society of Intensive Care Medicine Trials Group. Outcome of acute hypoxaemic respiratory failure: insights from the LUNG SAFE Study. Eur Respir J. 2021 Jun 10;57(6):2003317. doi: 10.1183/13993003.03317-2020. Print 2021 Jun.
- Derived from this study: PubMed 32234077Madotto F, Rezoagli E, Pham T, Schmidt M, McNicholas B, Protti A, Panwar R, Bellani G, Fan E, van Haren F, Brochard L, Laffey JG; LUNG SAFE Investigators and the ESICM Trials Group. Hyperoxemia and excess oxygen use in early acute respiratory distress syndrome: insights from the LUNG SAFE study. Crit Care. 2020 Mar 31;24(1):125. doi: 10.1186/s13054-020-2826-6.
- Derived from this study: PubMed 32088180Duggal A, Rezoagli E, Pham T, McNicholas BA, Fan E, Bellani G, Rubenfeld G, Pesenti AM, Laffey JG; LUNG SAFE Investigators and the ESICM Trials Group. Patterns of Use of Adjunctive Therapies in Patients With Early Moderate to Severe ARDS: Insights From the LUNG SAFE Study. Chest. 2020 Jun;157(6):1497-1505. doi: 10.1016/j.chest.2020.01.041. Epub 2020 Feb 20.
- Derived from this study: PubMed 30367670Boyle AJ, Madotto F, Laffey JG, Bellani G, Pham T, Pesenti A, Thompson BT, O'Kane CM, Deane AM, McAuley DF; LUNG SAFE Investigators; ESICM Trials Group. Identifying associations between diabetes and acute respiratory distress syndrome in patients with acute hypoxemic respiratory failure: an analysis of the LUNG SAFE database. Crit Care. 2018 Oct 27;22(1):268. doi: 10.1186/s13054-018-2158-y.
- Derived from this study: PubMed 30115127Abe T, Madotto F, Pham T, Nagata I, Uchida M, Tamiya N, Kurahashi K, Bellani G, Laffey JG; LUNG-SAFE Investigators and the ESICM Trials Group. Epidemiology and patterns of tracheostomy practice in patients with acute respiratory distress syndrome in ICUs across 50 countries. Crit Care. 2018 Aug 17;22(1):195. doi: 10.1186/s13054-018-2126-6.
- Derived from this study: PubMed 29895331Cortegiani A, Madotto F, Gregoretti C, Bellani G, Laffey JG, Pham T, Van Haren F, Giarratano A, Antonelli M, Pesenti A, Grasselli G; LUNG SAFE Investigators and the ESICM Trials Group. Immunocompromised patients with acute respiratory distress syndrome: secondary analysis of the LUNG SAFE database. Crit Care. 2018 Jun 12;22(1):157. doi: 10.1186/s13054-018-2079-9.
- Derived from this study: PubMed 29632996Madotto F, Pham T, Bellani G, Bos LD, Simonis FD, Fan E, Artigas A, Brochard L, Schultz MJ, Laffey JG; LUNG SAFE Investigators and the ESICM Trials Group. Resolved versus confirmed ARDS after 24 h: insights from the LUNG SAFE study. Intensive Care Med. 2018 May;44(5):564-577. doi: 10.1007/s00134-018-5152-6. Epub 2018 Apr 9.
- Derived from this study: PubMed 28631088de Prost N, Pham T, Carteaux G, Mekontso Dessap A, Brun-Buisson C, Fan E, Bellani G, Laffey J, Mercat A, Brochard L, Maitre B; LUNG SAFE investigators; ESICM trials group; REVA network. Etiologies, diagnostic work-up and outcomes of acute respiratory distress syndrome with no common risk factor: a prospective multicenter study. Ann Intensive Care. 2017 Dec;7(1):69. doi: 10.1186/s13613-017-0281-6. Epub 2017 Jun 19.
- Related InfoLink provided by the sponsor.
Related trials for Acute Severe Respiratory Failure
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 3
Efficacy and Safety of Tozorakimab in Patients Hospitalised for Viral Lung Infection Requiring Supplemental Oxygen
Viral Lung Infection and Acute Respiratory Failure
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
Not yet recruitingObservational study
Right Heart Injury Monitoring on ECMO
Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF)
RecruitingPhase 3
Inhaled Dornase Alpha to Reduce Respiratory Failure After Severe Trauma
Multiple Trauma, Respiratory Distress Syndrome, Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John LAFFEY, MD principal investigator
National University of Galway, Ireland and St Michael's Hospital-University of Toronto, Canada
Antonio PESENTI, MD principal investigator
S Gerardo Hospital, University of Milan-Bicocca, Monza, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Severe Respiratory Failure and Acute Respiratory Distress Syndrome, run by European Society of Intensive Care Medicine at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of ARDS (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02010073, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2014.