Ireland
--:--IST
Recruiting Not applicable

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

NCT05717218 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-03-11
Last updated
2025-05-15

Condition(s) studied

Severe ARDS

Investigational drug(s) / intervention(s)

Ultra-protective mechanical ventilation monitored by electrical impedance tomography

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.

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

Primary outcome measure(s)

  • cumulated collapse and overdistention percentages for each tidal volume by impedancemetry method — One day
    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.

Trial sites (1)

FacilityCityRegionStatus
Service de médecine intensive - réanimation Hopital Pitié Salpêtrière Paris France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05717218 on ClinicalTrials.gov ↗ ← All trials in France