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

NCT02836444 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 422

Last updated 2018-10-11

No results posted yet for this study

Summary

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.

Conditions

  • Acute Respiratory Distress Syndrome

Sponsors & Collaborators

  • Asociación Científica Pulmón y Ventilación Mecánica

    collaborator OTHER

  • Spanish Research Center for Respiratory Diseases

    collaborator OTHER

  • Dr. Negrin University Hospital

    lead OTHER

Principal Investigators

  • Jesús Villar, MD, PhD · Hospital Universitario Dr. Negrin

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2017-05-01
Completion
2017-05-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02836444 on ClinicalTrials.gov