Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms

  • Acute Lung Injury
  • Acute Respiratory Distress Syndrome (ARDS)
  • Respiratory Distress Syndrome, Adult
  • Respiratory Distress Syndrome, Newborn
  • Syndrome

NCT number NCT02288949
Study type Observational
Source Dr. Negrin University Hospital
Contact
Status Completed
Phase
Start date September 2013
Completion date July 2015

See also
  Status Clinical Trial Phase
Completed NCT03909854 - Pragmatic Investigation of Volume Targeted Ventilation-1 N/A
Recruiting NCT02637011 - Surviving ARDS: The Influence of Quality of Care and Individual Patient Characteristics on Quality of Life N/A
Recruiting NCT02574169 - Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation N/A
Completed NCT04548739 - Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
Terminated NCT04511650 - Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019 Phase 2
Completed NCT05024500 - Clinical and Functional Outcomes of Critically Ill Patients With COVID-19 N/A
Recruiting NCT01339533 - Airway Pressure Release Ventilation (APRV) Versus AC/VC Conventional Ventilation Phase 2
Active, not recruiting NCT01274260 - Trial of Steroids in Pediatric Acute Lung Injury/ARDS Phase 2
Recruiting NCT03296059 - Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates N/A
Terminated NCT04609865 - Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia Phase 3
Active, not recruiting NCT04009330 - Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome
Not yet recruiting NCT06127381 - An Open-label Study of the Safety and Pharmacokinetics of the TGKP Phase 1
Not yet recruiting NCT05847517 - Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN) Phase 3
Completed NCT01854424 - Validation of the Percentage of Alveolar Fibrocyte as Biomarker During ARDS N/A
Completed NCT03870009 - Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS N/A
Completed NCT04311697 - Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure Phase 2/Phase 3
Recruiting NCT02095444 - Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection Phase 1/Phase 2
Recruiting NCT04460859 - RecruitmEnt Assessed by eleCtRical Impedance Tomography
Completed NCT01926093 - Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients N/A
Terminated NCT01506401 - The Oscillation for Acute Respiratory Distress Syndrome (ARDS) Treated Early (OSCILLATE) Trial Phase 3