Acute Severe Respiratory FailureCO2 LUNG SAFENCT03415529
Impact of Arterial CO2 Tension on Management and Outcome in Patients With Acute Hypoxemic Respirator Failure and ARDS
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
There appears to be considerable variability in the approach physicians use to manage arterial carbon dioxide tensions, in patients in the early phases [first 48 hours] of ARDS (Acute hypoxemic respiratory failure and). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Severe Respiratory Failure, Acute Respiratory Distress Syndrome
- How many people
- 4,500 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2018to 30 Dec 2018
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients over 18 years of age who fulfilled clinical criteria for ARDS and Acute Hypoxaemic respiratory failure were recruited into the LUNG SAFE trial (NCT02010073) that was published in JAMA, 2016 Jul 19;316(3):347).
Who may be able to join
- All patients meeting criteria for ARDS. Fulfillment of criteria for Acute Hypoxaemic respiratory failure (AHRF) and fulfillment of Berlin criteria for ARDS during the first two days after AHRF onset.
Who cannot join
- Age < 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Hypercapnia and Impact of Arterial CO2 Tension on Management and Outcome in Patients With Acute Respiratory Distress Syndrome (ARDS)
There appears to be considerable variability in the approach physicians use to manage arterial carbon dioxide tensions, in patients in the early phases [first 48 hours] of ARDS (Acute hypoxemic respiratory failure and). A number of specific concerns exist, particularly the use of greater than needed inspired oxygen concentrations (potentially in 40% patients), and the proportion of hypocapnic patients in our cohort.
Read the detailed description
This study will address a number of specific concerns, including:
- the incidence of hypocapnia and hypercapnia;
- the factors (e.g. ventilatory mode) contributing to hypocapnia and hypercapnia;
- the impact of hypocapnia and hypercapnia on progression of ARDS, duration of ventilation, ICU stay, hospital stay and patient outcome;
- the impact of pH (respiratory versus metabolic cause) on outcome variables.
LUNG SAFE was a prospective observational study. There was not patient intervention. The current analysis is a secondary analysis of this existing database.
Data will be abstracted form the database on all patients meeting the inclusion criteria for ARDS (during the first 2 days from AHRF onset) for the following variables: Patient's demographic characteristics (age, sex) and chronic comorbidities, Arterial PCO2, pH in first 48 hours, Data on P/F ratio over course of illness, Duration of ventilation, ICU stay, hospital survival in patients identified as being exposed to hypocapnia (pCO2 < or = to 30mmHg) and hypercapnia (PCO2 > or = to 45mmHg); Main ventilatory variables: mode of ventilation, tidal volume, respiratory.
Descriptive statistics will include proportions for categorical and mean (standard deviation) or median (interquartile range) for continuous variables, according the data distribution. The amount of missing data in the LUNG SAFE database is low so no assumptions will be made for missing data.
In order to investigate the relationship between PaCO2 and management factors, the investigators will stratify study population according the presence or absence of hypercapnia and will evaluate differences in management factors, using appropriate statistical tests. In detail, proportions will be compared using chi-squared or Fisher exact tests and mean values were compared using T-test or Wilcoxon rank sum test, as appropriate. Shapiro-Wilks test will be used to assess normality in data distribution. Moreover, they will perform univariate and multivariable logistic regression models using hypercapnia as dependent variable. Stepwise regression approach with significance alpha levels of 0.05 (both for entry and retention) will be used to establish a set of independent predictors. Odds ratios (ORs) and 95% confidence intervals (CIs) will be reported as measure of association.
They will assess the association of hypercapnia with different outcomes (ARDS progression, duration of mechanical ventilation, ICU and hospital stay and mortality) using generalized linear regression models (Poisson or Logistic regression models, according outcome distribution) and adjusting the relationship with all possible confounders identified with stepwise approach. Results will be reported as ORs, incidence rate ratios and corresponding 95% CI.
Particular attention will be given to the relationship and interaction between pH and PaCO2.
Survival analysis (Kaplan-Meier approach) will be used to estimate the time of liberation from invasive mechanical ventilation, of ICU and hospital discharge, and of hospital mortality within 28 days of AHRF onset in patients with and without hypercapnia. Differences in survival time will be assess by Log-Rank test.
- Keywords
- Lung, ARDS, Acute Respiratory Syndrome, Prognosis, Outcome Research, Respiratory infection, Sepsis, Organ failure, Hypercapnia
- Medical subject headings
- Respiratory Distress Syndrome, Respiratory Tract Infections, Sepsis, Hypercapnia
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 |
|---|---|---|
| 4500 patients with ARDS | This is a secondary analysis of data from the LUNG SAFE database to determine the impact of alterations in arterial carbon dioxide tensions in patients with ARDS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence
The incidence of hypercapnia [i.e. PaCO2 > 45 mmHg] when ARDS arises
Measured: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Secondary outcomes (4)
Severity
The severity of hypercapnia [i.e. PaCO2 > 45 mmHg] when ARDS arises ARDS
Measured: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Hypercapnia
Factors (e.g. ventilatory mode) contributing to hypercapnia in patients with ARDS
Measured: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Hypercapnia
The impact of hypercapnia on outcome on the progression of ARDS
Measured: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
pH ((potential of hydrogen)
The impact of pH (respiratory versus metabolic cause) on outcome variables
Measured: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start1 Mar 2018
- Primary completion30 Sep 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Retrospective
- Enrolment
- 4,500 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, Principal investigator, National University of Ireland, Galway, IrelandGiacomo BELLANI, Principal investigator, University of Milano-Bicocca (Monza, Italy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03415529
- Sponsor's protocol ID
- CO2LUNGSAFE
- Acronym
- CO2 LUNG SAFE
- Status last verified
- Aug 2019
- First submitted
- 17 Jan 2018
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bellani 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 26903337Laffey 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; ESICM Trials Group. Correction to: Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study. Intensive Care Med. 2018 Jan;44(1):157-165. doi: 10.1007/s00134-017-4981-z.
PubMed 29138899de 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 28624388Dreyfuss D, Gaudry S, Madotto F, Laffey JG. Some remaining important questions after LUNG SAFE : Discussion of "Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study". Intensive Care Med. 2017 Apr;43(4):598-599. doi: 10.1007/s00134-017-4706-3. Epub 2017 Feb 17. No abstract available.
PubMed 28213623Laffey 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, Madotto F, Fan E, Brochard L, Esteban A, Gattinoni L, Bumbasirevic V, Piquilloud L, van Haren F, Larsson A, McAuley DF, Bauer PR, Arabi YM, Ranieri M, Antonelli M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Noninvasive Ventilation of Patients with Acute Respiratory Distress Syndrome. Insights from the LUNG SAFE Study. Am J Respir Crit Care Med. 2017 Jan 1;195(1):67-77. doi: 10.1164/rccm.201606-1306OC.
PubMed 27753501Bellani G, Laffey JG, Pham T, Fan E; LUNG SAFE Investigators and the ESICM Trials Group. The LUNG SAFE study: a presentation of the prevalence of ARDS according to the Berlin Definition! Crit Care. 2016 Sep 9;20(1):268. doi: 10.1186/s13054-016-1443-x. No abstract available.
PubMed 27608629Bellani G, Pham T, Laffey J; LUNG-SAFE Investigators; ESICM Trials Group. Incidence of Acute Respiratory Distress Syndrome--Reply. JAMA. 2016 Jul 19;316(3):347. doi: 10.1001/jama.2016.6471. No abstract available.
PubMed 27434453
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Hypercapnia and Impact of Arterial CO2 Tension on Management and Outcome in Patients With Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT03415529
- Acronym / sponsor ID
- CO2 LUNG SAFE / CO2LUNGSAFE
- Keywords
- Lung, ARDS, Acute Respiratory Syndrome, Prognosis, Outcome Research, Respiratory infection, Sepsis, Organ failure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,500 participants (actual)
- Lead sponsor
- European Society of Intensive Care MedicineUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 30 Sep 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 30 Jan 2018 (actual)
- 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.
There appears to be considerable variability in the approach physicians use to manage arterial carbon dioxide tensions, in patients in the early phases [first 48 hours] of ARDS (Acute hypoxemic respiratory failure and). A number of specific concerns exist, particularly the use of greater than needed inspired oxygen concentrations (potentially in 40% patients), and the proportion of hypocapnic patients in our cohort.
Detailed description
This study will address a number of specific concerns, including:
- the incidence of hypocapnia and hypercapnia;
- the factors (e.g. ventilatory mode) contributing to hypocapnia and hypercapnia;
- the impact of hypocapnia and hypercapnia on progression of ARDS, duration of ventilation, ICU stay, hospital stay and patient outcome;
- the impact of pH (respiratory versus metabolic cause) on outcome variables.
LUNG SAFE was a prospective observational study. There was not patient intervention. The current analysis is a secondary analysis of this existing database.
Data will be abstracted form the database on all patients meeting the inclusion criteria for ARDS (during the first 2 days from AHRF onset) for the following variables: Patient's demographic characteristics (age, sex) and chronic comorbidities, Arterial PCO2, pH in first 48 hours, Data on P/F ratio over course of illness, Duration of ventilation, ICU stay, hospital survival in patients identified as being exposed to hypocapnia (pCO2 < or = to 30mmHg) and hypercapnia (PCO2 > or = to 45mmHg); Main ventilatory variables: mode of ventilation, tidal volume, respiratory.
Descriptive statistics will include proportions for categorical and mean (standard deviation) or median (interquartile range) for continuous variables, according the data distribution. The amount of missing data in the LUNG SAFE database is low so no assumptions will be made for missing data.
In order to investigate the relationship between PaCO2 and management factors, the investigators will stratify study population according the presence or absence of hypercapnia and will evaluate differences in management factors, using appropriate statistical tests. In detail, proportions will be compared using chi-squared or Fisher exact tests and mean values were compared using T-test or Wilcoxon rank sum test, as appropriate. Shapiro-Wilks test will be used to assess normality in data distribution. Moreover, they will perform univariate and multivariable logistic regression models using hypercapnia as dependent variable. Stepwise regression approach with significance alpha levels of 0.05 (both for entry and retention) will be used to establish a set of independent predictors. Odds ratios (ORs) and 95% confidence intervals (CIs) will be reported as measure of association.
They will assess the association of hypercapnia with different outcomes (ARDS progression, duration of mechanical ventilation, ICU and hospital stay and mortality) using generalized linear regression models (Poisson or Logistic regression models, according outcome distribution) and adjusting the relationship with all possible confounders identified with stepwise approach. Results will be reported as ORs, incidence rate ratios and corresponding 95% CI.
Particular attention will be given to the relationship and interaction between pH and PaCO2.
Survival analysis (Kaplan-Meier approach) will be used to estimate the time of liberation from invasive mechanical ventilation, of ICU and hospital discharge, and of hospital mortality within 28 days of AHRF onset in patients with and without hypercapnia. Differences in survival time will be assess by Log-Rank test.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 4500 patients with ARDS | – | –This is a secondary analysis of data from the LUNG SAFE database to determine the impact of alterations in arterial carbon dioxide tensions in patients with ARDS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age who fulfilled clinical criteria for ARDS and Acute Hypoxaemic respiratory failure were recruited into the LUNG SAFE trial (NCT02010073) that was published in JAMA, 2016 Jul 19;316(3):347).
Key inclusion criteria (1 listed)
- All patients meeting criteria for ARDS. Fulfillment of criteria for Acute Hypoxaemic respiratory failure (AHRF) and fulfillment of Berlin criteria for ARDS during the first two days after AHRF onset.
Key exclusion criteria (1 listed)
- Age < 18
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
Incidence
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
The incidence of hypercapnia [i.e. PaCO2 > 45 mmHg] when ARDS arises
4 secondary outcomes
Severity
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Hypercapnia
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
Hypercapnia
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
pH ((potential of hydrogen)
Time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first
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 14 Aug 2019.
- Background: PubMed 26903337Bellani 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.
- Background: PubMed 29138899Laffey 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; ESICM Trials Group. Correction to: Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study. Intensive Care Med. 2018 Jan;44(1):157-165. doi: 10.1007/s00134-017-4981-z.
- Background: 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.
- Background: PubMed 28624388Laffey 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.
- Background: PubMed 28213623Dreyfuss D, Gaudry S, Madotto F, Laffey JG. Some remaining important questions after LUNG SAFE : Discussion of "Potentially modifiable factors contributing to outcome from acute respiratory distress syndrome: the LUNG SAFE study". Intensive Care Med. 2017 Apr;43(4):598-599. doi: 10.1007/s00134-017-4706-3. Epub 2017 Feb 17. No abstract available.
- Background: PubMed 27757516Laffey 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.
- Background: PubMed 27753501Bellani G, Laffey JG, Pham T, Madotto F, Fan E, Brochard L, Esteban A, Gattinoni L, Bumbasirevic V, Piquilloud L, van Haren F, Larsson A, McAuley DF, Bauer PR, Arabi YM, Ranieri M, Antonelli M, Rubenfeld GD, Thompson BT, Wrigge H, Slutsky AS, Pesenti A; LUNG SAFE Investigators; ESICM Trials Group. Noninvasive Ventilation of Patients with Acute Respiratory Distress Syndrome. Insights from the LUNG SAFE Study. Am J Respir Crit Care Med. 2017 Jan 1;195(1):67-77. doi: 10.1164/rccm.201606-1306OC.
- Background: PubMed 27608629Bellani G, Laffey JG, Pham T, Fan E; LUNG SAFE Investigators and the ESICM Trials Group. The LUNG SAFE study: a presentation of the prevalence of ARDS according to the Berlin Definition! Crit Care. 2016 Sep 9;20(1):268. doi: 10.1186/s13054-016-1443-x. No abstract available.
- Background: PubMed 27434453Bellani G, Pham T, Laffey J; LUNG-SAFE Investigators; ESICM Trials Group. Incidence of Acute Respiratory Distress Syndrome--Reply. JAMA. 2016 Jul 19;316(3):347. doi: 10.1001/jama.2016.6471. No abstract available.
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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 principal investigator
National University of Ireland, Galway, Ireland
Giacomo BELLANI principal investigator
University of Milano-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 14 Aug 2019. 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?
Incidence (time frame: LUNG SAFE was a prospective observational study. Patients were followed until hospital discharge or day 90, whichever came first). 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 NCT03415529, which also lists 9 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 14 Aug 2019.