Effects of PEEP and FIO2 in ALI and ARDS (HELP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00435110
Recruitment Status : Completed
First Posted : February 14, 2007
Last Update Posted : October 11, 2018
Asociación Científica Pulmón y Ventilación Mecánica
Information provided by:
Instituto Canario de Investigacion Biomedica

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).

Condition or disease Intervention/treatment
Acute Respiratory Distress Syndrome Acute Lung Injury Acute Respiratory Failure Procedure: standard ventilatory settings Procedure: PEEP and FiO2

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.

Study Type : Observational
Actual Enrollment : 178 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effects of PEEP and FiO2 in the Evaluation of Severity of ALI and ARDS
Study Start Date : May 2004
Study Completion Date : October 2005

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00435110

Hospital Universitario NS de Candelaria
Santa Cruz de Tenerife, Canary Islands, Spain, 38010
Sponsors and Collaborators
Instituto Canario de Investigacion Biomedica
Asociación Científica Pulmón y Ventilación Mecánica
Principal Investigator: Jesus Villar, MD, PhD Instituto Canario de Investigación Biomédica

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00435110     History of Changes
Other Study ID Numbers: 22
First Posted: February 14, 2007    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Keywords provided by Instituto Canario de Investigacion Biomedica:
Mechanical Ventilation

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Acute Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Thoracic Injuries
Wounds and Injuries