NCT05406570 Personalized Tidal Volume in ARDS (VT4HEMOD)
| NCT ID | NCT05406570 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2022-12-29 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2022-12-29 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 observational studies (40 to 50%). Approximately 30% of ARDS patients exhibit tidal hyperinflation despite low tidal volume ventilation, suggesting that personalization of tidal volume is required to improve ARDS prognostic. To date, reliable bedside tools to adjust tidal volume are lacking. Excessive tidal volume can be detected using computed tomography by quantification of tidal hyperinflation, but this technique is reserved to research studies and requires patient transport to imaging facility. Mechanical ventilation generates cardio-pulmonary interaction, whose magnitude is influenced by tidal volume and respiratory system characteristics. Pulse pressure variation is a bedside tool with potential to quantify cardio-pulmonary interactions. Increasing tidal volume will decrease right ventricular preload and increase right ventricular afterload, hence maximizing cardio-pulmonary interactions. The investigators hypothesize that pulse pressure variation might help to detect excessive tidal volume during a tidal volume challenge (i.e. stepwise increase in tidal volume)
Eligibility Criteria
Inclusion Criteria: 1. Age greater then 18 years old 2. ARDS according to the BERLIN definition with PaO2/FiO2 ratio ≤ 150 mm Hg 3. invasive mechanical ventilation in volume controlled mode with tidal volume set to 6 ml/kg predicted body weight 4. use of sedation and neuromuscular-blocking agents 5. arterial catheter allowing computation of pulse contour cardiac output calibrated with thermodilution 6. central venous catheter implanted in the superior vena cava territory 7. esophageal balloon 8. Computed tomography planned by attending physician Exclusion Criteria: 1. Previous inclusion in current study 2. Acute cor pulmonale 3. ECMO 4. Arterial pH \< 7.21 despite respiratory rate set to a maximum of 35/min 5. Pneumothorax or bronchopleural fistula 6. Decision to withdraw or withhold life sustaining treatment with 24 hours from inclusion 7. Contra-indication of transport to imaging facility 8. Intracranial hypertension 9. Tricuspid or pulmonary mechanical valve 10. Tricuspid or pulmonary infective endocarditis 11. Pace maker with intracardiac leads 12. Right ventricle tumor 13. Complete left bundle block 14. Intrathoracic metallic device 15. COPD 16. Cardiac arrythmia 17. Vesical pressure \> 15 mm Hg 18. Lower limb amputation 19. Inferior vena cava thrombosis 20. Patient under an exclusion period relative to participation to another clinical trial 21. Patient under a legal protective measure 22. Patient not affiliated to social security 23. lac of patient/representative consent 24. Pregnancy 25. Breast feeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05406570 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05406570 currently recruiting?
Yes, NCT05406570 is actively recruiting participants. Contact the research team at j-christophe.richard@chu-lyon.fr for enrollment information.
Where is the NCT05406570 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT05406570 clinical trial?
NCT05406570 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 10 participants.