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

Acute Respiratory Distress Syndrome Clinical Trial

— POVA-TIE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386720
• Other study ID #: CHUBX 2020/15
• Status: Completed
• Start date: May 25, 2020
• Est. completion date: May 25, 2022

Study information

• Verified date: August 2022
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: May 25, 2022
• Est. primary completion date: May 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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)

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Locations

Country	Name	City	State
France	HOPITAL HAUT-LEVEQUE - Service Réanimation thoracique	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the PV curves	global ventilator method vs regional EIT derived method in all patients	At inclusion day
Secondary	Comparison of regional AOP	Global ventilator method vs regional EIT derived method in regional AOP, right and left lungs	At inclusion day
Secondary	Comparison of the different AOPs with the level of PEEP	Comparison selected by the EIT-PEEP method	At inclusion day