Optimization of PEEP for Alveolar Recruitment in ARDS | NCT01949272

Studies
Optimization of PEEP for Alveolar Recruitment in ARDS

NCT01949272

Sponsor

Hopital of Melun

Status

Completed

Last Update Posted

Jun 27, 2016Estimated

Enrollment

22Actual

Phase

Not provided

Conditions

ARDS

Interventions

esophageal pressure mesurement

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Mar 2016Actual

Completion Date

May 2016Actual

First Submitted Date

Sep 19, 2013

First Submission Date that Met QC Criteria

Sep 19, 2013

First Posted Date

Sep 24, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2016

Last Update Posted Date

Jun 27, 2016Estimated

Name	Class
Melun Hospital Intensive Care Unit	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ARDS		ARDS patients achieving stades II and III of Berlin 2011 Classification	Device: esophageal pressure mesurement

Interventions

Name	Type	Description	Arm Group Labels	Other Names
esophageal pressure mesurement	Device	"EXPRESS study" ventilatory setting the optimization of PEEP with esophageal pressure mesurement	ARDS

Measure	Description	Time Frame
PaO2/FiO2 ratio		24 hours

Measure	Description	Time Frame
Vd/Vt ratio		24 hours

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Mehran Monchi, MD	Melun Hospital ICU	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Melun Hospital ICU		Melun		77000	France