Personalized tidal volume adjustment for patients with ARDS
Personalized Tidal Volume According to Cardiopulmonary Interactions in ARDS
This study is testing if adjusting breathing settings on ventilators based on individual patient needs can help people with Acute Respiratory Distress Syndrome breathe better and improve their chances of recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 1 site (Lyon) |
| Trial ID | NCT05406570 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the treatment of Acute Respiratory Distress Syndrome (ARDS) by personalizing tidal volume settings during mechanical ventilation. It addresses the high mortality rates associated with ARDS by utilizing a bedside tool to quantify cardio-pulmonary interactions, which may help in adjusting tidal volume more effectively. The study will involve patients who are already on invasive mechanical ventilation and will assess the impact of personalized ventilation strategies compared to standardized approaches. The use of computed tomography to detect excessive tidal volume will also be explored, although this requires patient transport.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old diagnosed with ARDS and requiring invasive mechanical ventilation.
Not a fit: Patients with acute cor pulmonale, those on ECMO, or those with severe contraindications for transport to imaging facilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates in ARDS patients by optimizing ventilation strategies.
How similar studies have performed: While the personalization of tidal volume in ARDS is a novel approach, previous studies have indicated the importance of individualized ventilation strategies, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lyon
- Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation — Lyon, France (Recruiting)
Study contacts
- Study coordinator: Jean-Christophe RICHARD
- Email: j-christophe.richard@chu-lyon.fr
- Phone: +33 426109272
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.