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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04386720
Recruitment Status : Recruiting
First Posted : May 13, 2020
Last Update Posted : May 27, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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.


Condition or disease
Acute Respiratory Distress Syndrome

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.

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Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Measurement of Airway Opening Pressure (AOP) in Patients With Acute Respiratory Distress Syndrom With Pressure Volume Curve on the Ventilator and With Electrical Impedance Tomography (EIT) Derived Method in Comparison of the Curves in Patients With or Without Covid 19 Pneumoniae.
Actual Study Start Date : May 25, 2020
Estimated Primary Completion Date : May 25, 2021
Estimated Study Completion Date : May 25, 2021





Primary Outcome Measures :
  1. Comparison of the PV curves [ Time Frame: At inclusion day ]
    global ventilator method vs regional EIT derived method in all patients


Secondary Outcome Measures :
  1. Comparison of regional AOP [ Time Frame: At inclusion day ]
    Global ventilator method vs regional EIT derived method in regional AOP, right and left lungs

  2. Comparison of the different AOPs with the level of PEEP [ Time Frame: At inclusion day ]
    Comparison selected by the EIT-PEEP method



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04386720


Contacts
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Contact: Hadrien ROZE, Dr 557656866 ext +33 hadrien.roze@chu-bordeaux.fr
Contact: Eline BONNARDEL, Dr 557656866 ext +33 eline.bonnardel@chu-bordeaux.fr

Locations
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France
HOPITAL HAUT-LEVEQUE - Service Réanimation thoracique Recruiting
Pessac, France, 33604
Contact: Hadrien ROZE, Dr    05 57 65 68 66    hadrien.roze@chu-bordeaux.fr   
Sub-Investigator: Eline BONNARDEL, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT04386720    
Other Study ID Numbers: CHUBX 2020/15
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: May 27, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Bordeaux:
Ventilation Induced Lung Injury
Airway Closer
Airway Opening Pressure
Electrical Impedance Tomography
Pressure Volume curve
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury