NCT04386720

Brief Summary

Mechanical ventilation in ARDS requires protective ventilation and PEEP. Airway closer has to be overcome to reduce lung heterogeneity, AOP is measured globally with a ventilator PV curve without PEEP. EIT derived PV curve is another method that could determine heterogeneity of AOP between both lung. This study aims to determine whether AOP measured with EIT derived PV curve is similar to AOP on the ventilator PV curve and see if AOP is different between lungs. If airway closer is higher on one lung, global AOP on the ventilator PV curve probably estimates the other lung.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2020

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

First Submitted

Initial submission to the registry

May 11, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

May 25, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2022

Completed
Last Updated

August 29, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

May 11, 2020

Last Update Submit

August 26, 2022

Conditions

Acute Respiratory Distress Syndrome

Keywords

Ventilation Induced Lung InjuryAirway CloserAirway Opening PressureElectrical Impedance TomographyPressure Volume curve

Outcome Measures

Primary Outcomes (1)

  • Comparison of the PV curves

    global ventilator method vs regional EIT derived method in all patients

    At inclusion day

Secondary Outcomes (2)

  • Comparison of regional AOP

    At inclusion day

  • Comparison of the different AOPs with the level of PEEP

    At inclusion day

Eligibility Criteria

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

Consecutive patients hospitalized in thoracic intensive care of Haut-Lévêque Hospital, with moderate to severe ARDS according to the Berlin criteria.

You may qualify if:

  • \- Patients hospitalized in the ICU and who suffered moderate to severe ARDS (Berlin criteria) equipped EIT over the age of 18.

You may not qualify if:

  • Broncho-pleural leaks
  • ECMO
  • Pregnant or breastfeeding woman.
  • Guardianship or curatorship
  • Deprived of liberty
  • No health insurance
  • Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.)
  • Contra indications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HOPITAL HAUT-LEVEQUE - Service Réanimation thoracique

Pessac, 33604, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2020

First Posted

May 13, 2020

Study Start

May 25, 2020

Primary Completion

May 25, 2022

Study Completion

May 25, 2022

Last Updated

August 29, 2022

Record last verified: 2022-08

Locations

FR(1)