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

NCT05717218 | Recruiting

• 1 other identifier: APHP230064
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Severe ARDS

Keywords

ECMO; ARDS; ultra-protective mechanical ventilation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Optimal PEEP by impedancemetry method at each tidal volume

  One day

• cumulated collapsed and overdistended for each tidal volume by impedancemetry method with application of optimal PEEP

  One day

Study Arms (1)

Interventional

EXPERIMENTAL

All patients included

Device: Ultra-protective mechanical ventilation monitored by electrical impedance tomography

Interventions

Ultra-protective mechanical ventilation monitored by electrical impedance tomography 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.

Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Service de médecine intensive - réanimation Hopital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Central Study Contacts

Matthieu Pr SCHMIDT

CONTACT

01 42 16 29 37; matthieu.schmidt@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 8, 2023
• Study Start: March 11, 2023
• Primary Completion (Estimated): March 11, 2027
• Study Completion (Estimated): May 11, 2027
• Last Updated: May 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)