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

October 9, 2018 updated by: Instituto Canario de Investigacion Biomedica

Effects of PEEP and FiO2 in the Evaluation of Severity of 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Canary Islands
      • Santa Cruz de Tenerife, Canary Islands, Spain, 38010
        • Hospital Universitario NS de Candelaria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Canario de Investigacion Biomedica

Collaborators

Asociación Científica Pulmón y Ventilación Mecánica

Investigators

  • Principal Investigator: Jesus Villar, MD, PhD, Instituto Canario de Investigación Biomédica

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

February 12, 2007

First Submitted That Met QC Criteria

February 13, 2007

First Posted (Estimate)

February 14, 2007

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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