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

January 30, 2024 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • La Tronche, France, 38700
        • Recruiting
        • Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes
        • Contact:
        • Principal Investigator:
          • Nicolas TERZI, Pr
      • Lyon, France, 69004
        • Recruiting
        • Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation
        • Contact:
        • Contact:
      • Pierre-Bénite, France, 69310
        • Recruiting
        • Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon
        • Contact:
        • Principal Investigator:
          • Florent WALLET, Dr
      • Rennes, France
        • Recruiting
        • Centre Hospitalier Universitaire de Rennes
        • Contact:
        • Principal Investigator:
          • Jean Marc TADIE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Odd ratio of tidal hyperinflation assessed on CT at day-0 as an independent predictor of 90-day mortality
Time Frame: 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
Day-0 (time of realization of CT scan)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2020

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

October 27, 2023

First Submitted That Met QC Criteria

October 27, 2023

First Posted (Actual)

November 2, 2023

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL21_0664
  • 194_v3 (Registry Identifier: CNIL)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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