Effects of PEEP and FIO2 in ALI and ARDS

Acute Respiratory Distress Syndrome Clinical Trial

— HELP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00435110
• Other study ID #: 22
• Status: Completed
• Start date: May 2004
• Est. completion date: October 2005

Study information

• Verified date: October 2018
• Source: Instituto Canario de Investigacion Biomedica
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Acute Respiratory Failure
• Lung Injury
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency

Intervention

Procedure:
• standard ventilatory settings

• PEEP and FiO2

Locations

Country	Name	City	State
Spain	Hospital Universitario NS de Candelaria	Santa Cruz de Tenerife	Canary Islands

Sponsors (2)

Lead Sponsor	Collaborator
Instituto Canario de Investigacion Biomedica	Asociación Científica Pulmón y Ventilación Mecánica

Country where clinical trial is conducted

Spain,