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NCT01949272 Clinical Trial

Optimization of PEEP for Alveolar Recruitment in ARDS

ARDS Clinical Trial

— OPERA  

Official title:
Optimization of PEEP for Alveolar Recruitment in ARDS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01949272
Other study ID # OPERA
Secondary ID
Status Completed
Phase N/A
First received September 19, 2013
Last updated June 24, 2016
Start date September 2013
Est. completion date May 2016

Study information
Verified date June 2016
Source Hopital of Melun
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date May 2016
Est. primary completion date March 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Device:
• esophageal pressure mesurement
"EXPRESS study" ventilatory setting the optimization of PEEP with esophageal pressure mesurement

Locations
Country Name City State
France Melun Hospital ICU Melun

Sponsors (2)
Lead Sponsor Collaborator
Hopital of Melun Melun Hospital Intensive Care Unit

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary PaO2/FiO2 ratio 24 hours Yes
Secondary Vd/Vt ratio 24 hours Yes
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