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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05717218
Acronym
EIT-ECMO
Enrollment
50
Registered
2023-02-08
Start date
2023-03-11
Completion date
2027-05-11
Last updated
2025-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe ARDS

Keywords

ECMO, ARDS, ultra-protective mechanical ventilation

Brief 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

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.

Interventions

DEVICEUltra-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.

Sponsors

Assistance Publique - Hôpitaux de Paris
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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)

Design outcomes

Primary

MeasureTime frameDescription
cumulated collapse and overdistention percentages for each tidal volume by impedancemetry methodOne dayEstimating 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.

Secondary

MeasureTime frameDescription
Optimal PEEP by impedancemetry method at each tidal volumeOne dayPEEP titration will be performed to identify the optimal PEEP setting that combines the best alveolar recruitment with minimal overdistention at each tidal volume
cumulated collapsed and overdistended for each tidal volume by impedancemetry method with application of optimal PEEPOne dayEstimating 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

Countries

France

Contacts

Primary ContactMatthieu Pr SCHMIDT
matthieu.schmidt@aphp.fr01 42 16 29 37

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026