Acute Respiratory Distress Syndrome (ARDS)CT4-ARDSNCT03870009
Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS
A study testing ARDS patients in people with Acute Respiratory Distress Syndrome (ARDS), run by Hospices Civils de Lyon at 1 site in France.
Trial summary
This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients. The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- What is being tested?
- ARDS patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 21 May 2019to 16 Feb 2021
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARDS patients defined by the Berlin definition
- invasive mechanical ventilation with an arterial oxygen pressure (PaO2)/inspired fraction of oxygen (FiO2) ratio ≤ 200 mm Hg
- Indication of CT scan identified by the clinician in charge
- oesophageal catheter already inserted
Who cannot join
- requirement of contrast agent for a chest CT-scan
- ARDS criteria present for more than 72 hours
- Chronic Obstructive Pulmonary Disease (COPD) on a previous lung function test
- pneumothorax or bronchopleural fistula
- patient without both sedation and neuromuscular blocking agents
- contra-indication to transport to the imaging facility
Show all 15Show fewer
- treatment with extracorporeal membrane oxygenation or extracorporeal carbon dioxide (CO2) removal
- Latex or curare allergy
- patient previously included in the study
- pregnancy
- patient under limitation of care
- patient under an exclusion period following inclusion in another clinical trial
- patient under a legal protective measure
- patient unaffiliated with social security
- inform consent not obtained by next of kin
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients.
The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung.
- Being tested
- ARDS patients
- Keywords
- ARDS, computed tomography, cyclic hyperinflation, mechanical ventilation
- 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.
ARDS patientsOther
Also called CT measurements
The patient will be installed on the scanner bed. Two series of tomographic sections will be acquired: one during an expiratory break, the other during an inspiratory pause.
cyclic hyperinflation measured by semi-automatic segmentation and by manual segmentation
| Study group | Role | What they receive |
|---|---|---|
| ARDS patients | Experimental | All the patients will be evaluated with the same procedure, as the study relates to evaluation of the diagnostic performance of a semi-automated method to detect cyclic hyperinflation on CT scan Receives: Other: ARDS patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
cyclic hyperinflation measured by manual segmentation
Bias and precision of semi-automated measure will be assessed with the Bland and Altman Technique, using cyclic hyperinflation by manual segmentation as a reference
Measured: 2 hours after inclusion
cyclic hyperinflation measured by semi-automated segmentation
Bias and precision of semi-automated measure will be assessed with the Bland and Altman Technique, using cyclic hyperinflation by manual segmentation as a reference
Measured: 2 hours after inclusion
Secondary outcomes (3)
prevalence of cyclic hyperinflation on CT scan
cyclic hyperinflation assessed by manual segmentation on CT scan
Measured: 2 hours after inclusion
area under receiver operating characteristic (ROC) curve of respiratory system driving pressure to detect cyclic hyperinflation assessed by manual segmentation
Measured: 2 hours after inclusion
area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation
Measured: 2 hours after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start21 May 2019
- Primary completion16 Feb 2021
- Study completion16 Feb 2021
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 Syndrome (ARDS)Studies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Christophe Richard, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870009
- Sponsor's protocol ID
- 69HCL18_1001
- Other IDs
- 2019-A00024-53
- Acronym
- CT4-ARDS
- Status last verified
- Aug 2022
- First submitted
- 8 Mar 2019
- Last updated
- 22 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
E. Dávila Serrano, François Dhelft, Laurent Bitker, Jean-Christophe Richard, Maciej Orkisz. Software for CT-image Analysis to Assist the Choice of Mechanical-ventilation Settings in Acute Respiratory Distress Syndrome. 2020 International Conference on Computer Vision and Graphics (ICCVG 2020), Sep 2020, Varsovie, Poland. ff10.1007/978-3-030-59006-2_5ff. ffhal-02887264
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS
- ClinicalTrials.gov ID
- NCT03870009
- Acronym / sponsor ID
- CT4-ARDS / 69HCL18_1001
- Keywords
- ARDS, computed tomography, cyclic hyperinflation, mechanical ventilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 May 2019 (actual)
- Primary completion
- 16 Feb 2021 (actual)
- Study completion
- 16 Feb 2021 (actual)
- First posted
- 11 Mar 2019 (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.
This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients.
The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ARDS patients | Experimental | Other: ARDS patientsAll the patients will be evaluated with the same procedure, as the study relates to evaluation of the diagnostic performance of a semi-automated method to detect cyclic hyperinflation on CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ARDS patients defined by the Berlin definition
- invasive mechanical ventilation with an arterial oxygen pressure (PaO2)/inspired fraction of oxygen (FiO2) ratio ≤ 200 mm Hg
- Indication of CT scan identified by the clinician in charge
- oesophageal catheter already inserted
Key exclusion criteria (15 listed)
- requirement of contrast agent for a chest CT-scan
- ARDS criteria present for more than 72 hours
- Chronic Obstructive Pulmonary Disease (COPD) on a previous lung function test
- pneumothorax or bronchopleural fistula
- patient without both sedation and neuromuscular blocking agents
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 |
|---|---|---|
| ARDS patientsAlso: CT measurementsThe patient will be installed on the scanner bed. Two series of tomographic sections will be acquired: one during an expiratory break, the other during an inspiratory pause. cyclic hyperinflation measured by semi-automatic segmentation and by manual segmentation | Other | ARDS patients |
Primary outcome
cyclic hyperinflation measured by manual segmentation
Time frame: 2 hours after inclusion
Bias and precision of semi-automated measure will be assessed with the Bland and Altman Technique, using cyclic hyperinflation by manual segmentation as a reference
cyclic hyperinflation measured by semi-automated segmentation
Time frame: 2 hours after inclusion
Bias and precision of semi-automated measure will be assessed with the Bland and Altman Technique, using cyclic hyperinflation by manual segmentation as a reference
3 secondary outcomes
prevalence of cyclic hyperinflation on CT scan
Time frame: 2 hours after inclusion
area under receiver operating characteristic (ROC) curve of respiratory system driving pressure to detect cyclic hyperinflation assessed by manual segmentation
Time frame: 2 hours after inclusion
area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation
Time frame: 2 hours after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Results publicationE. Dávila Serrano, François Dhelft, Laurent Bitker, Jean-Christophe Richard, Maciej Orkisz. Software for CT-image Analysis to Assist the Choice of Mechanical-ventilation Settings in Acute Respiratory Distress Syndrome. 2020 International Conference on Computer Vision and Graphics (ICCVG 2020), Sep 2020, Varsovie, Poland. ff10.1007/978-3-030-59006-2_5ff. ffhal-02887264
Related trials for Acute Respiratory Distress Syndrome (ARDS)
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
RecruitingObservational study
Pulmonary Immune Cell-microbiome Interactions in ARDS
ARDS, Human
RecruitingPhase 2
Rhu-pGSN for Acute Respiratory Distress Syndrome (ARDS)
Acute Respiratory Distress Syndrome, Infections
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
Not yet recruitingObservational study
Right Heart Injury Monitoring on ECMO
Acute Respiratory Distress Syndrome (ARDS), Acute Respiratory Failure (ARF)
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.
Jean Christophe Richard principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ARDS patients in people with Acute Respiratory Distress Syndrome (ARDS), run by Hospices Civils de Lyon at 1 site 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 4 inclusion and 15 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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cyclic hyperinflation measured by manual segmentation (time frame: 2 hours after inclusion). The study lists 2 primary outcomes in all. 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 NCT03870009, 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 22 Aug 2025.