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Recruiting NCT05717218

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

No phase Interventional Severe ARDS

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultra-protective mechanical ventilation monitored by electrical impedance tomography.
Who it may be relevant to
Registry conditions: Severe ARDS. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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

  • Device 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.

Primary outcome measures

  • cumulated collapse and overdistention percentages for each tidal volume by impedancemetry method [Time frame: One day]
Secondary outcome measures (2)
  • Optimal PEEP by impedancemetry method at each tidal volume [Time frame: One day]
  • cumulated collapsed and overdistended for each tidal volume by impedancemetry method with application of optimal PEEP [Time frame: One day]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Service de médecine intensive - réanimation Hopital Pitié Salpêtrière — Paris

Identifiers

NCT: NCT05717218 · APHP230064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗