Quantitative Computed Tomography for Mortality Risk Stratification in ARDS (CT4ARDS-2)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Acute Respiratory Distress Syndrome

Treatments: Radiation: Low dose computed tomography to evaluate biomechanical parameters in the lung

Study type: Observational

Funder types: Other

Identifiers

NCT06113276

194_v3 (Registry Identifier)

69HCL21_0664

Details and patient eligibility

About

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.

Enrollment: 210 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

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

Trial design

210 participants in 1 patient group

tidal hyperinflation

Description:

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)

Treatment:

Radiation: Low dose computed tomography to evaluate biomechanical parameters in the lung