Acute Respiratory Distress SyndromeCT4ARDS-2NCT06113276
Quantitative Computed Tomography for Mortality Risk Stratification in ARDS
An observational study of Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- Low dose computed tomography to evaluate biomechanical parameters in the lung
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 4 sitesFrance
- Study dates
- 6 Nov 2020to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients will be screened from the population of patient hospitalized for ARDS in the participating centers
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes
La Tronche, 38700
Nicolas TERZI, Pr, 04-76-76-87-79 ext. +33, nterzi@chu-grenoble.fr
Nicolas TERZI, Pr
- Recruiting
Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation
Lyon, 69004
Jean-Christophe RICHARD, +33 426109272, j-christophe.richard@chu-lyon.fr
William Danjou, +33 472071762, william.danjou@chu-lyon.fr
- Recruiting
Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon
Pierre-Bénite, 69310
Florent WALLET, MD, 04 78 86 21 62 ext. +33, florent.wallet@chu-lyon.fr
Florent WALLET, Dr
- Recruiting
Centre Hospitalier Universitaire de Rennes
Rennes
Jean Marc TADIE, MD, 02 99 28 43 21, jean-marc.tadie@chu-rennes.fr
Jean Marc TADIE, MD
About this study
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
- Being tested
- Low dose computed tomography to evaluate biomechanical parameters in the lung
- Keywords
- ARDS, computed tomography, alveolar recruitment, PEEP, tidal hyperinflation
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose computed tomography to evaluate biomechanical parameters in the lungRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Radiation: Low dose computed tomography to evaluate biomechanical parameters in the lung |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day-0 (time of realization of CT scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2023
- Study start6 Nov 2020
- Primary completion1 Nov 2024 (estimated)
- Study completion1 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06113276
- Sponsor's protocol ID
- 69HCL21_0664
- Other IDs
- 194_v3
- Acronym
- CT4ARDS-2
- Status last verified
- Jan 2024
- First submitted
- 27 Oct 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40346553
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Computed Tomography for Mortality Risk Stratification in ARDS
- ClinicalTrials.gov ID
- NCT06113276
- Acronym / sponsor ID
- CT4ARDS-2 / 69HCL21_0664
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ARDS, computed tomography, alveolar recruitment, PEEP, tidal hyperinflation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 6 Nov 2020 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 1 May 2025 (estimated)
- First posted
- 2 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tidal hyperinflation | – | Radiation: Low dose computed tomography to evaluate biomechanical parameters in the lungAs 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) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients will be screened from the population of patient hospitalized for ARDS in the participating centers
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose computed tomography to evaluate biomechanical parameters in the lungIn 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. | Radiation | tidal hyperinflation |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 40346553Shekarnabi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Service de Médecine Intensive Réanimation Hôpital Michallon - CHU Grenoble Alpes
La Tronche, France
Hospices Civils de Lyon - Hôpital de la Croix Rousse - Service de Médecine Intensive Réanimation
Lyon, France
Service de Réanimation Polyvalente Centre Hospitalier Lyon Sud Hospices Civils de Lyon
Pierre-Bénite, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Respiratory Distress Syndrome, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06113276, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.