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RecruitingNCT06113276CT4ARDS-2Updated Jan 31, 2024

Quantitative Computed Tomography for Mortality Risk Stratification in ARDS

An observational study in Acute Respiratory Distress Syndrome, sponsored by Hospices Civils de Lyon. Recruiting at 4 sites in France. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.

Sponsored by Hospices Civils de Lyon · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2020; still recruiting 5 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
210
Ages
15 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Acute Respiratory Distress Syndrome

Keywords

  • ARDS
  • computed tomography
  • alveolar recruitment
  • PEEP
  • tidal hyperinflation
03

In context

Respiratory Distress Syndrome

1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.

This study's planned enrollment of 210 is above the median of 100 across 540 observational studies indexed under Respiratory Distress Syndrome.

Browse Respiratory Distress Syndrome studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

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
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
210 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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.

06

What researchers measure

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

    Time frame: Day-0 (time of realization of CT scan)

07

Study locations

4 of 4 sites recruiting
  • Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes
    La Tronche, 38700, France
    • Nicolas TERZI, Pr · Contact · nterzi@chu-grenoble.fr · 04-76-76-87-79
    • Nicolas TERZI, Pr · Principal investigator
    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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06113276
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Nov 2, 2023
Start date
Nov 6, 2020
Primary completion
Nov 1, 2024 (estimated)
Completion
May 1, 2025 (estimated)
Last update
Jan 31, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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