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
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|
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.
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.
|Study Type :||Observational|
|Estimated Enrollment :||20 participants|
|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|
- Comparison of the PV curves [ Time Frame: At inclusion day ]global ventilator method vs regional EIT derived method in all patients
- Comparison of regional AOP [ Time Frame: At inclusion day ]Global ventilator method vs regional EIT derived method in regional AOP, right and left lungs
- Comparison of the different AOPs with the level of PEEP [ Time Frame: At inclusion day ]Comparison selected by the EIT-PEEP method
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
|Contact: Hadrien ROZE, Dr||557656866 ext +email@example.com|
|Contact: Eline BONNARDEL, Dr||557656866 ext +firstname.lastname@example.org|
|HOPITAL HAUT-LEVEQUE - Service Réanimation thoracique||Recruiting|
|Pessac, France, 33604|
|Contact: Hadrien ROZE, Dr 05 57 65 68 66 email@example.com|
|Sub-Investigator: Eline BONNARDEL, Dr|