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NCT Number: NCT02836444

Stratification of the Acute Respiratory Distress Syndrome - A Second Phase Study

Current definitions of the Acute Respiratory Distress Syndrome (ARDS) could be adequate for epidemiological studies but are not adequate for inclusion of patients into therapeutic clinical trials. It is a matter of debate whether the assessment of hypoxemia at ARDS onset is appropriate for stratifying lung severity and risk of death in ARDS patients. The investigators will perform an observational, non-interventional, multicenter, prospective audit in a network of intensive care units in Spain for evaluating the severity and risk of death based on the assessment of respiratory and ventilatory function at 24 hours after ARDS diagnosis under standardized ventilatory conditions. This study is the confirmatory phase of the study NCT02288949.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario Mutua de Terrassa, Terrassa, Barcelona, Spain

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About this study

In 2012, an update of 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 mmHg), and mild (>200 - ≤300 mmHg) on positive end-expiratory pressure (PEEP) ≥5 cmH2O. However, despite that there is sufficient evidence about the interactions between PEEP and FiO2, these cut-off values did not mandate the assessment of hypoxemia under standardized 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, is still a matter of debate whether the assessment of hypoxemia must be performed at 24 hours instead of at ARDS onset, and whether the assessment of hypoxemia under standardized ventilator settings is the most appropriate tool for stratifying lung severity in patients with ARDS.

The investigators will examine whether the values of relevant variables (including age, plateau pressure, driving pressure, compliance, PaO2/FiO2) at 24 after ARDS diagnosis under standardized ventilator settings have an impact on the stratification and prediction of death in ARDS patients. This study is an extension of the study NCT02288949.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients meeting the Berlin criteria for moderate and severe ARDS.

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. variables associated with highest and lowest mortality

    Time frame: at 24 hours

    variables associated with highest and lowest mortality

Secondary outcomes

  1. stratification by risk of death

    Time frame: at 24 hours

    stratification by risk of death

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Gran Canaria Doctor Negrín

Other

Collaborators

  • Asociación Científica Pulmón y Ventilación Mecánica
  • Spanish Research Center for Respiratory Diseases

Registry information

Official study title

STratification AND Outcome of Patients With the Acute Respiratory Distress Syndrome - A Second Phase Study

Acronym: STANDARDS-2

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 19, 2016
Registry last updated
Oct 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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