CT4ARDS-2: Quantitative Computed Tomography for Mortality Risk Stratification in ARDS
Study Details
Study Description
Brief Summary
Acute respiratory distress syndrome remains a deadly disease with hospital mortality remaining between 40 to 50%. ARDS mortality risk factors have been identified from patient history, common clinical and biological variables in the lung SAFE study. Part of ARDS mortality is attributable to ventilator-induced lung injury (VILI), in relation with inappropriate settings on the ventilator. Tidal hyperinflation and recruitment/derecruitment during lung inflation are 2 identified mechanisms leading to VILI, that may be identified on computed tomography while poorly identified with variables collected at the bedside.
The aim of this study is to identify whether tidal hyperinflation identified on computed tomography is a risk factor for ARDS mortality, independently from know bio-clinical risk factors.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| tidal hyperinflation As the study aim to identify whether tidal hyperinflation is an independent predictor for ARDS mortality, and as this variable will be entered as a quantitative predictor in the multivariate model, the study encompass a single group of patient (i.e. all included patients) |
Radiation: Low dose computed tomography to evaluate biomechanical parameters in the lung
In the participating to the study, response to PEEP increase and tidal inflation are evaluated with a software computing biomechanical parameters (tidal hyperinflation and lung recruitability). Tidal hyperinflation and recruitment are computed on CT images acquired within 72 hours after ARDS onset or with 72h after ECMO onset.
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Outcome Measures
Primary Outcome Measures
- Odd ratio of tidal hyperinflation assessed on CT at day-0 as an independent predictor of 90-day mortality [Day-0 (time of realization of CT scan)]
Tidal hyperinflation is computed as the volume difference of hyperinflated lung (i.e., with CT attenuation between -1000 and -900 Hounsfield units) between and-expiration and end-inspiration at the PEEP level chosen by clinician
Eligibility Criteria
Criteria
Inclusion Criteria:
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- Patient aged 15 or older with ARDS according to the Berlin definition 2. invasive mechanical ventilation with PaO2/FiO2 ≤ 300 mm Hg 3. with computed tomography acquired at both end-expiration and end-inspiration, or at both PEEP 5 and 15 cm H2O at end-expiration 4. PEEP setting according to a PEEP/FiO2 table, with secondary adjustment according to hemodynamic tolerance 5. Tidal volume 6 ml/kg of predicted body weight or less
Exclusion Criteria:
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- Use of contrast agent during computed tomography acquisition 2. ARDS criteria onset since more than 72 hours or ECMO onset since more than 72 hours 3. Proven COPD 4. Pneumothorax or bronchopleural fistula 5. Patient with spontaneous breathing preventing realization of end-expiratory and end-inspiratory pauses 6. Previous inclusion in current study 7. Patient under a legal protective measure
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes | La Tronche | France | 38700 | |
| 2 | Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation | Lyon | France | 69004 | |
| 3 | Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon | Pierre-Bénite | France | 69310 | |
| 4 | Centre Hospitalier Universitaire de Rennes | Rennes | France |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL21_0664
- 194_v3