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Recruiting Observational

EIT Assessment of Overdistension in ARDS Patients in Prone Position

NCT06536543 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2024-10-15
Last updated
2026-01-15

Condition(s) studied

Acute Respiratory Distress Syndrome

Investigational drug(s) / intervention(s)

Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT)

Acute Respiratory Distress Syndrom (ARDS) treated with Prone Position (PP) equipped with Electrical Impedance Tomography (EIT): Positive End-Expiratory Pressure (PEEP) will be titrated with PEEP-EIT method as it is already done in usual care. A classical low flow Pression Volume (PV) curve will be done in order to detect airway closure and measure compliance, the acquisition of EIT data during PV curve will be analysed secondary with a dedicated software. Reconstruction of EIT derived PV curve will determine the regional airway opening pressures and compliances of the 2 lungs. Two decremental PEEP-EIT titrations will be compared, one in supine and the other just after turning in prone.

Study summary

Mechanical ventilation in ARDS requires protective ventilation with low VT and PEEP. PEEP titration can improve lung recruitment in the dependent lung but with a risk of overdistension in the non-dependant lung. EIT can measure the distribution of tidal ventilation and assess overdistension and collapse during a PEEP titration in any position (prone or not).

This study aims to measure the best PEEP as a compromise between recruitment and overdistension during a PEEP trial with EIT before and just after PP.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients hospitalized in the ICU and who suffered moderate or severe ARDS (Berlin criteria, PaO2/FiO2\<150), intubated sedated, under myorelaxant and equipped with EIT * Over the age of 18. Exclusion Criteria: * Broncho-pleural leaks * Pregnant or breastfeeding woman. * Guardianship or curatorship * Deprived of liberty * No health insurance * Impossibility to correctly position the EIT belt (e.g., dressings, chest drainage, etc.) * Contra indications to EIT (e.g., implantable cardiac defibrillator, pacemaker, instable spinal lesions)

Primary outcome measure(s)

  • Level of distension — 48 hours after inclusion day
    Assessing the level of distension when titrating the optimal PEEP in the supine position (SP) and in the PP position the first and second day of ARDS in PP. The measure will be obtained thanks to the crossing in EIT of the overdistension curve and the collapse curve when the PEEP is reduced from 20 to 5 cmH2O.

Trial sites (2)

FacilityCityRegionStatus
CH Cote Basque Bayonne France Recruiting
Hopital Haut-Lévêque Pessac 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 NCT06536543 on ClinicalTrials.gov ↗ ← All trials in France