Optimization of PEEP for Alveolar Recruitment in ARDS (OPERA)

June 24, 2016 updated by: Sebastien Jochmans, MD, Hopital of Melun
Actual setting of PEEP in ARDS is based on tables linked to FiO2, or respiratory system plateau pressure (e.g EXPRESS Study) or set regarding esophageal pressure mesurement and transpulmonary pressure calculation. Opera study should confirm if a setting approach based on esophageal pressure is helpfull for any ARDS patient in ICU without deleterious side-effect.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

22

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

  • France
      • Melun, France, 77000
        • Melun Hospital ICU

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All ICU patients achievinf definition of ARDS stades II and III of Berlin Classification

Description

Inclusion Criteria:

  • ARDS Stades 2 and 3 with invasive ventilation (EXPRESS settings) within 3 to 12 hours

Exclusion Criteria:

  • less 18 years, pregnancy, intracardiac shunt, esophageal catheter cons-indicated

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ARDS
ARDS patients achieving stades II and III of Berlin 2011 Classification
Device: esophageal pressure mesurement
"EXPRESS study" ventilatory setting the optimization of PEEP with esophageal pressure mesurement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
PaO2/FiO2 ratio
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Vd/Vt ratio
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Hopital of Melun

Collaborators

Melun Hospital Intensive Care Unit

Investigators

  • Study Director: Mehran Monchi, MD, Melun Hospital ICU

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

September 1, 2013

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (ESTIMATE)

September 24, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2016

Last Update Submitted That Met QC Criteria

June 24, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • OPERA (Alias Study Number)

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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