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OpenTrials
Completed

NCT Number: NCT00435110

Effects of PEEP and FIO2 in ALI and ARDS

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).

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario NS de Candelaria

Santa Cruz de Tenerife, Canary Islands, 38010, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

standard ventilatory settings

Procedure

PEEP and FiO2

Procedure

Sponsors and collaborators

Lead sponsor

Instituto Canario de Investigacion Biomedica

Other

Collaborators

  • Asociación Científica Pulmón y Ventilación Mecánica

Registry information

Official study title

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

Acronym: HELP

Important dates

Study start
2004
Study completion
2005
First posted
Feb 14, 2007
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.

View the official ClinicalTrials.gov record (opens in a new tab)

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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