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CompletedNCT04386720POVA-TIEUpdated Aug 29, 2022

Measurement of Airway Opening Pressure (AOP) in Patients With Acute Respiratory Distress Syndrom and With or Without Covid 19.

An observational study in Acute Respiratory Distress Syndrome, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-29.

Sponsored by University Hospital, Bordeaux · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
26
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Scientific justification:

In one third of Acute Respiratory Distress Syndrome (ARDS), tidal inflation starts when an airway opening pressure (AOP) is overcome 1. This phenomenon of airway closure has been underestimated and misinterpreted. Recent research demonstrates that airway closure is a matter of concern as it participates to the heterogeneity of tidal ventilation distribution and it can amplify Ventilator Induced Lung Injury (VILI). The detection of airway closure and the measurement of AOP need a pressure volume curve at low flow and no positive end expiratory pressure (PEEP). However, this will measure a global AOP whereas ventilation is heterogeneous between the two lungs in ARDS. EIT is an interesting monitoring tool that could allow EIT derived PV curve construction with measurement of regional AOP2, right vs left lung. The investigor wants to compare global AOP on ventilator PV curve with left and right lung EIT derived AOP measurements. Recent Covid 19 pneumoniae is responsible for numerous acute respiratory distress with severe hypoxemia. Phenotypes are discussed with differences in terms of respiratory mechanics. It is therefore important to describe specifically Covid 19 patients with ARDS.

Strategy description:

Patients with moderate to severe ARDS equipped with EIT will be included. PEEP will be titrated with PEEP-EIT method. A classical low flow PV curve from without PEEP will be done, the acquisition of EIT data during PV curve will be analysed secondary with a dedicated software. PV curve on the ventilator will be analysed to determine if there is an airway closer phenomenon. Reconstruction of EIT derived PV curve will determine, first: if there is a left and/or right lung airway closer phenomenon, and second: the value of each lung AOP.

Follow up description:

  • Measurement of ventilator pressures, flow and volume before/during/after the PV curve.
  • Last chest X Ray and arterial blood gases,
  • Haemodynamic data.
02

Conditions studied

  • Acute Respiratory Distress Syndrome

Keywords

  • Ventilation Induced Lung Injury
  • Airway Closer
  • Airway Opening Pressure
  • Electrical Impedance Tomography
  • Pressure Volume curve
03

In context

Respiratory Distress Syndrome

1,596 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's enrollment of 26 is below the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Inclusion criteria

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

Exclusion criteria

  • 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)
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
26 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Comparison of the PV curves

    global ventilator method vs regional EIT derived method in all patients

    Time frame: At inclusion day

Secondary outcomes

  1. Comparison of regional AOP

    Global ventilator method vs regional EIT derived method in regional AOP, right and left lungs

    Time frame: At inclusion day

  2. Comparison of the different AOPs with the level of PEEP

    Comparison selected by the EIT-PEEP method

    Time frame: At inclusion day

07

Study locations

1 site
  • HOPITAL HAUT-LEVEQUE - Service Réanimation thoracique
    Pessac, 33604, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04386720
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
May 13, 2020
Start date
May 25, 2020
Primary completion
May 25, 2022
Completion
May 25, 2022
Last update
Aug 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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