Using CT scans to assess mortality risk in ARDS patients
Quantitative Computed Tomography for Mortality Risk Stratification in ARDS
This study is trying to see if special CT scans can help doctors figure out the risk of death in patients with Acute Respiratory Distress Syndrome who are on ventilators.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (La Tronche and 3 other locations) |
| Trial ID | NCT06113276 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate whether tidal hyperinflation, identified through low-dose computed tomography (CT), is an independent risk factor for mortality in patients with Acute Respiratory Distress Syndrome (ARDS). The study will involve patients aged 15 and older who are on invasive mechanical ventilation and meet specific criteria related to their ARDS condition. CT scans will be performed at both end-expiration and end-inspiration to assess biomechanical parameters in the lungs, which may not be adequately captured through traditional bedside assessments. The findings could enhance understanding of ventilator-induced lung injury and improve risk stratification for ARDS patients.
Who should consider this trial
Good fit: Ideal candidates are patients aged 15 or older diagnosed with ARDS who are on invasive mechanical ventilation.
Not a fit: Patients with proven COPD, pneumothorax, or those who have had ARDS for more than 72 hours may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved mortality risk assessment and management strategies for ARDS patients.
How similar studies have performed: While there have been studies on ARDS and ventilator settings, this specific approach using CT for mortality risk stratification is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient aged 15 or older with ARDS according to the Berlin definition * invasive mechanical ventilation with PaO2/FiO2 ≤ 300 mm Hg * with computed tomography acquired at both end-expiration and end-inspiration, or at both PEEP 5 and 15 cm H2O at end-expiration * PEEP setting according to a PEEP/FiO2 table, with secondary adjustment according to hemodynamic tolerance * Tidal volume 6 ml/kg of predicted body weight or less Exclusion Criteria: * Use of contrast agent during computed tomography acquisition * ARDS criteria onset since more than 72 hours or ECMO onset since more than 72 hours * Proven COPD * Pneumothorax or bronchopleural fistula * Patient with spontaneous breathing preventing realization of end-expiratory and end-inspiratory pauses * Previous inclusion in current study * Patient under a legal protective measure
Where this trial is running
La Tronche and 3 other locations
- Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes — La Tronche, France (Recruiting)
- Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation — Lyon, France (Recruiting)
- Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon — Pierre-Bénite, France (Recruiting)
- Centre Hospitalier Universitaire de Rennes — Rennes, France (Recruiting)
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.