NCT01949272

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 19, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

June 27, 2016

Status Verified

June 1, 2016

Enrollment Period

2.5 years

First QC Date

September 19, 2013

Last Update Submit

June 24, 2016

Conditions

ARDS

Keywords

ARDS

Outcome Measures

Primary Outcomes (1)

  • PaO2/FiO2 ratio

    24 hours

Secondary Outcomes (1)

  • Vd/Vt ratio

    24 hours

Study Arms (1)

ARDS

ARDS patients achieving stades II and III of Berlin 2011 Classification

Device: esophageal pressure mesurement

Interventions

esophageal pressure mesurementDEVICE

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

ARDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melun Hospital ICU

Melun, 77000, France

Location

Study Officials

  • Mehran Monchi, MD

    Melun Hospital ICU

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 19, 2013

First Posted

September 24, 2013

Study Start

September 1, 2013

Primary Completion

March 1, 2016

Study Completion

May 1, 2016

Last Updated

June 27, 2016

Record last verified: 2016-06

Locations

FR(1)