Monitoring ultra-protective ventilation in severe ARDS patients on ECMO
Ultra-protective Ventilation Monitored by Electrical Impedance Tomography in Patients With Severe Acute Respiratory Distress Syndrome on Veno-venous ECMO
This study is testing a new way to help patients with severe lung problems on ECMO by adjusting their breathing support to see if it can protect their lungs better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05717218 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with severe acute respiratory distress syndrome (ARDS) who are supported by venovenous ECMO. It aims to monitor the effects of ultra-protective mechanical ventilation using electrical impedance tomography, adjusting tidal volumes to minimize lung overdistension and derecruitment. The study will systematically lower tidal volumes while keeping other ventilator parameters constant, and will also explore the optimal PEEP settings to enhance lung recruitment. The goal is to identify the best tidal volume and PEEP combination for lung protection in these critically ill patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with severe ARDS requiring venovenous ECMO support.
Not a fit: Patients who are pregnant, have certain cardiac devices, or are hemodynamically unstable may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve lung protection and outcomes for patients with severe ARDS on ECMO.
How similar studies have performed: While the approach of using electrical impedance tomography in this context is innovative, similar studies have shown promise in optimizing ventilation strategies for ARDS patients.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Paris
- Service de médecine intensive - réanimation Hopital Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Matthieu Pr SCHMIDT
- Email: matthieu.schmidt@aphp.fr
- Phone: 01 42 16 29 37
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.