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Effects of PEEP and FIO2 in ALI and ARDS

Effects of PEEP and FiO2 in the Evaluation of Severity of ALI and ARDS

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00435110
Acronym
HELP
Enrollment
178
Registered
2007-02-14
Start date
2004-05-31
Completion date
2005-10-31
Last updated
2018-10-11

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

Conditions

Acute Lung Injury, Acute Respiratory Distress Syndrome, Acute Respiratory Failure

Keywords

ARDS, ALI, Mechanical Ventilation, Outcome

Brief summary

Current American-European Consensus Conference (AECC) definitions for ALI and ARDS are inadequate for inclusion into clinical trials due to the lack of standardization for measuring the oxygenation defect. We questioned whether an early assessment of oxygenation on specific ventilator settings would identify patients with established ARDS (persisting over 24h).

Detailed description

We designed this study to determine whether standard ventilator settings applied on the day ARDS is identified (Day 0) or 24 hours (Day 1) later: (1) would have an impact on the reclassification of patients into ALI or ARDS, and (2) would identify groups with different clinical outcomes. Our hypothesis was that the assessment of PaO2/FiO2 on standard ventilator settings 24 hours after patients originally met the AECC definition of ARDS would identify patients with established ARDS (persisting over 24 h) from others with different degrees of lung injury. If this hypothesis is supported, it would suggest that patients with a better outcome could have been preferentially entered into one group of previously conducted clinical trials, resulting in a viable therapy being proved useless or useless therapy proven viable.

Interventions

PROCEDUREstandard ventilatory settings
PROCEDUREPEEP and FiO2

Sponsors

Asociación Científica Pulmón y Ventilación Mecánica
CollaboratorOTHER
Instituto Canario de Investigacion Biomedica
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

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

Inclusion criteria

* All patients meeting American-European Consensus Conference (AECC) ARDS criteria were approached for enrollment regardless of their current status or past medical history.

Exclusion criteria

* The only patients excluded were those in which \>24 hrs had pasted after initially meeting the AECC ARDS criteria before consent and results of initial standard ventilator settings could be obtained.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026