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Stratification of the Acute Respiratory Distress Syndrome

STratification AND Outcome of Patients With the Acute Respiratory Distress Syndrome

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02288949
Acronym
STANDARDS
Enrollment
300
Registered
2014-11-13
Start date
2013-09-30
Completion date
2015-07-31
Last updated
2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

mechanical ventilation, stratificacion, lung severity

Brief summary

The American-European Consensus Conference (AECC) and the Berlin definitions of the Acute Respiratory Distress Syndrome (ARDS) could be adequate for epidemiologic studies, but it is not adequate for inclusion of patients into therapeutic clinical trials. Despite recent reports on the effects of standardized ventilator settings on PaO2/FIO2 and fulfillment of AECC and Berlin definitions of ARDS, it is still a matter of debate whether the assessment of hypoxemia at 24 hours is the most appropriate tool for stratifying lung severity in patients with ARDS. The investigators will perform an observational, multicenter, prospective audit in a network of intensive care units in Spain and China for validating and confirming that the assessment of hypoxemia at 24 hours after ARDS onset is the most valuable tool for stratifying and predicting outcome in patients with ARDS.

Detailed description

In 1994, the American-European Consensus Conference (AECC) defined ARDS as follows: 1) acute and sudden onset of severe respiratory distress, 2) bilateral infiltrates on frontal chest radiograph, 3) absence of left atrial hypertension or no clinical signs of left heart failure, and 4) severe hypoxemia, as PaO2/FiO2 ratio \<200 mmHg, regardless of FIO2 or PEEP levels. Although this definition could be adequate for epidemiologic studies, it is not adequate for inclusion of patients into therapeutic clinical trials. In 2012, a proposal for updating the ARDS definition (the Berlin criteria) was published and an empirical classification was proposed according to three PaO2/FiO2 cut-off values at ARDS onset: severe (≤100 mmHg), moderate (\>100-≤200), and mild (\>200-≤300) on PEEP≥5 cmH2O. However, despite that there is sufficient evidence about the interactions between PEEP and FiO2, the Berlin criteria did not mandate the assessment of hypoxemia at 24 hours under standarized guidelines. The PaO2/FIO2 can be easily manipulated. Alterations in PEEP and FIO2 can dramatically change the PaO2/FIO2. Despite recent reports on the effects of standardized ventilator settings on PaO2/FIO2 and fulfillment of AECC definitions of ARDS, it is still a matter of debate whether the assessment of hypoxemia at 24 hours is the most appropriate tool for stratifying lung severity in patients with ARDS. The investigators will examine whether the assessment of hypoxemia at 24 h after ARDS diagnosis under standard guidelines for ventilatory management have an impact on the stratification of lung severity and on predicting mortality of ARDS patients in the intensive care unit.

Interventions

Patients will be stratified based on the values of relevant demographics, pulmonary and systemic variables in relation to mortality in the intensive care unit.

Sponsors

Asociación Científica Pulmón y Ventilación Mecánica
CollaboratorOTHER
Dr. Negrin University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients meeting the AECC definition for ARDS on PEEP greater or equal than 5 cmH2O (or the Berlin criteria for moderate and severe ARDS).

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frame
range of values of variables associated with the highest or lowest mortalitywithin the first 24 h of ARDS onset

Secondary

MeasureTime frame
stratification by risk of death based on variables associated with worst outcomeICU stay

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026