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

NCT ID: NCT05717218

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-11
• Study Completion Date: 2027-05-11

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.

Conditions

Severe ARDS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Interventional

All patients included

Group Type: EXPERIMENTAL

Ultra-protective mechanical ventilation monitored by electrical impedance tomography

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de médecine intensive - réanimation Hopital Pitié Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Matthieu Pr SCHMIDT

Role: CONTACT

matthieu.schmidt@aphp.fr

01 42 16 29 37

Facility Contacts

Matthieu Pr SCHMIDT

Role: primary

matthieu.schmidt@aphp.fr

01 42 16 29 37

Other Identifiers

APHP230064

Identifier Type: -

Identifier Source: org_study_id