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Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06113276
Acronym
CT4ARDS-2
Enrollment
210
Registered
2023-11-02
Start date
2020-11-06
Completion date
2025-05-01
Last updated
2024-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS, computed tomography, alveolar recruitment, PEEP, tidal hyperinflation

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.

Interventions

RADIATIONLow 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Odd ratio of tidal hyperinflation assessed on CT at day-0 as an independent predictor of 90-day mortalityDay-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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026