Status:

RECRUITING

Personalized Tidal Volume in ARDS (VT4HEMOD)

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

Acute Respiratory Distress Syndrome

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

Treatment of acute respiratory distress syndrome (ARDS) relies on invasive mechanical ventilation with supposedly protective settings (low tidal volume ventilation). Mortality of ARDS remains high in ...

Eligibility Criteria

Inclusion

  • Age greater then 18 years old
  • ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg
  • invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight
  • use of sedation and neuromuscular-blocking agents
  • arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution
  • central venous catheter implanted in the superior vena cava territory
  • esophageal balloon
  • Computed tomography planned by attending physician

Exclusion

  • Previous inclusion in current study
  • Acute cor pulmonale
  • ECMO
  • Arterial pH \< 7.21 despite respiratory rate set to a maximum of 35/min
  • Pneumothorax or bronchopleural fistula
  • Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion
  • Contra-indication of transport to imaging facility
  • Intracranial hypertension
  • Tricuspid or pulmonary mechanical valve
  • Tricuspid or pulmonary infective endocarditis
  • Pace maker with intracardiac leads
  • Right ventricle tumor
  • Complete left bundle block
  • Intrathoracic metallic device
  • COPD
  • Cardiac arrythmia
  • Vesical pressure \> 15 mm Hg
  • Lower limb amputation
  • Inferior vena cava thrombosis
  • Patient under an exclusion period relative to participation to another clinical trial
  • Patient under a legal protective measure
  • Patient not affiliated to social security
  • lac of patient/representative consent
  • Pregnancy
  • Breast feeding

Key Trial Info

Start Date :

December 29 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2026

Estimated Enrollment :

10 Patients enrolled

Trial Details

Trial ID

NCT05406570

Start Date

December 29 2022

End Date

December 1 2026

Last Update

November 19 2024

Active Locations (1)

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1

Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation

Lyon, France, 69004