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

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.

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 26

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

• 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the PV curves	global ventilator method vs regional EIT derived method in all patients	At inclusion day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of regional AOP	Global ventilator method vs regional EIT derived method in regional AOP, right and left lungs	At inclusion day
Comparison of the different AOPs with the level of PEEP	Comparison selected by the EIT-PEEP method	At inclusion day

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): May 25, 2020
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: May 11, 2020
• First Submitted That Met QC Criteria: May 11, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 29, 2022
• Last Update Submitted That Met QC Criteria: August 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Electrical Impedance Tomography; Ventilation Induced Lung Injury; Airway Closer; Airway Opening Pressure; Pressure Volume curve
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: CHUBX 2020/15

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No