Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

Recruiting

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Radiation: Low dose computed tomography to evaluate biomechanical parameters in the lung

• Registration Number: NCT06113276
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-06
• Study First Submitted: 2023-10-27
• Study First Submitted QC: 2023-10-27
• Study First Posted: 2023-11-02
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Primary Completion: 2024-11-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
tidal hyperinflation	Low dose computed tomography to evaluate biomechanical parameters in the lung	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)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes; 🇫🇷 La Tronche, France

Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France

Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation; 🇫🇷 Lyon, France

Centre Hospitalier Universitaire de Rennes; 🇫🇷 Rennes, France