Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

NCT06113276 | Unknown

• 2 other identifiers: 69HCL21_0664194_v3
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 4

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Odd ratio of tidal hyperinflation assessed on CT at day-0 as an independent predictor of 90-day mortality

  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

  Day-0 (time of realization of CT scan)

Study Arms (1)

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

Interventions

Low dose computed tomography to evaluate biomechanical parameters in the lung RADIATION

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.

tidal hyperinflation

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be screened from the population of patient hospitalized for ARDS in the participating centers

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient under a legal protective measure

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (4)

Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes

La Tronche, 38700, France

RECRUITING

Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation

Lyon, 69004, France

RECRUITING

Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon

Pierre-Bénite, 69310, France

RECRUITING

Centre Hospitalier Universitaire de Rennes

Rennes, France

RECRUITING

Related Publications (1)

• Shekarnabi M, Guillien A, Terzi N, Sigaud F, Bitker L, Roux E, Ahaouari T, Serrano EED, Boussel L, Ferretti G, Yonis H, Mezidi M, Noirot I, Chauvelot L, Dhelft F, Gaillet M, Siroux V, Orkisz M, Richard JC, Bayat S. Prognostic value of functional CT imaging in COVID-ARDS: a two-centre prospective observational study. Respir Res. 2025 May 9;26(1):177. doi: 10.1186/s12931-025-03232-7.

  PMID: 40346553 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 2, 2023
• Study Start: November 6, 2020
• Primary Completion: November 1, 2024
• Study Completion: May 1, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Locations

FR (4)