Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO (EIT-ECMO)

For ECMO supported patients with severe ARDS (acute respiratory distress syndrome), usual care include use of "ultraprotective" mechanical ventilation with tidal volume and pressure reductions that might ultimately enhance lung protection of patients with ARDS. Although very low tidal might also cause pulmonary derecruitment. The aim of this study is to monitor effects of very low tidal volume on regression of overdistension and derecruitment using electrical impedance tomography.

Secondary aim is to describe the evolution of the optimal PEEP (Positive End Expiratory Pressure) during the decrease of the tidal volume

Study Overview

• Status: Recruiting
• Conditions: Severe ARDS
• Intervention / Treatment: Device: Ultra-protective mechanical ventilation monitored by electrical impedance tomography

Detailed Description

Patients requiring venovenous ECMO support for severe ARDS will be monitored with electrical impedance tomography during introduction of "ultraprotective" mechanical ventilation.

Monitoring will start with pre-ECMO ventilator setting, then the tidal volume will be lowered step by step. Other parameters of the ventilator will be kept constant. Then, cumulated collapse and overdistention percentages will be estimated for each tidal volume. Optimal tidal volume will be defined by the lowest sum of alveolar overdistension and collapse.

Also, at the end of each step, PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention. The aim is to determine whether the derecruitment induced by the decrease in tidal volume can be reduced by the application of PEP. Then, comparison of the different tidal volumes with application of ideal PEEP will be performed: measurement of the percentage of collapsed and overdistended areas by impedancemetry method between the different levels of tidal volume with application of ideal PEEP.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Service de médecine intensive - réanimation Hopital Pitié Salpêtrière

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• aged ≥ 18 years
• patient with ARDS on venovenous (VV)-ECMO
• Written informed consent
• patient affiliated to a social security scheme

Exclusion Criteria:

• Pregnancy
• Adult patient subject to a legal protection measure (tutor, curator, etc.)
• Patients with a pacemaker, automatic implantable cardioverter defibrillator,
• contraindications to thoracic belt placement (e.g., thoracic or spinal cord trauma, recent thoracic surgery)
• undrained pneumothorax, bronchopleural fistula
• hemodynamic instability (i.e., use of intravenous fluids of more than 10 mL/kg or vasopressors 2 mg/h of norepinephrine or 0.5 mg/h of epinephrine)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional; All patients included	Device: Ultra-protective mechanical ventilation monitored by electrical impedance tomography; A silicone EIT belt will be placed around the patient's thorax (sixth intercostal parasternal space). EIT data will be generated by application of a small alternating electrical current (5 mA at 50 kHz). Introduction of "ultraprotective" mechanical ventilation will be monitored.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cumulated collapse and overdistention percentages for each tidal volume by impedancemetry method	Estimating the "best" lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with constant (pre-ECMO) PEEP.	One day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Optimal PEEP by impedancemetry method at each tidal volume	PEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention at each tidal volume	One day
cumulated collapsed and overdistended for each tidal volume by impedancemetry method with application of optimal PEEP	Estimating the "best" lung-compartment compliance, reflected by the number of functional lung units in that region, and current compliance for each pixel, the collapse and overdistention percentages per pixel will be compared for each tidal volume, with optimal PEEP	One day

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2023
• Primary Completion (Anticipated): March 11, 2025
• Study Completion (Anticipated): May 11, 2025

Study Registration Dates

• First Submitted: January 19, 2023
• First Submitted That Met QC Criteria: February 6, 2023
• First Posted (Actual): February 8, 2023

Study Record Updates

• Last Update Posted (Actual): April 10, 2023
• Last Update Submitted That Met QC Criteria: April 7, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: ARDS; ECMO; ultra-protective mechanical ventilation
• 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: APHP230064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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