Acute Respiratory Distress Syndrome (ARDS)CT 4 ARDSNCT07400445
Accuracy of the Chest Radiograph for the Diagnosis of Acute Respiratory Distress Syndrome
An observational study of Acute Respiratory Distress Syndrome (ARDS), run by Poitiers University Hospital at 1 site in France.
Trial summary
The presence of bilateral lung infiltrates on chest imaging is a mandatory criterion for the diagnosis of acute respiratory distress syndrome (ARDS). This retrospective single-center observational study assessed the agreement between chest radiograph interpreted by intensivists and chest computed tomography… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Distress Syndrome (ARDS)
- How many people
- 277 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to 31 Jan 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the medical intensive care unit of the University Hospital of Poitiers
Who may be able to join
- Adults admitted to intensive care unit
- Invasive mechanical ventilation
- Chest CT performed during ICU stay
- PaO2/FiO2 ≤ 300 mmHg with positive end-expiratory pressure ≥ 5 cmH2O the day of the CT-scan
- Chest radiograph performed within ± 24h of CT-scan
Who cannot join
- Cardiogenic pulmonary edema as the cause of hypoxemia
- Missing imaging data
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Intensive Réanimation, University Hospital of Poitiers
Poitiers
About this study
Official title: Interobserver Agreement Between Chest Radiograph and Computed Tomography for the Diagnosis of Acute Respiratory Distress Syndrome
The presence of bilateral lung infiltrates on chest imaging is a mandatory criterion for the diagnosis of acute respiratory distress syndrome (ARDS). This retrospective single-center observational study assessed the agreement between chest radiograph interpreted by intensivists and chest computed tomography interpreted by radiologists for the diagnosis of ARDS in mechanically ventilated patients with hypoxemia. Chest CT was considered the reference standard. The study evaluated interobserver agreement and diagnostic performance of chest radiography in the overall population and in predefined subgroups.
Read the detailed description
Retrospective, single-center observational study conducted in the medical ICU of University Hospital of Poitiers, France, from January 1, 2015 to December 31, 2021. Included were intubated patients with PaO2/FiO2 ≤ 300 mmHg, PEEP ≥5 cmH2O, suspected ARDS except for imaging criterion, who underwent both chest CT and chest radiograph on the same day. Chest CT was interpreted by radiologists and used as reference for ARDS diagnosis. Chest radiographs were interpreted by intensivists. Agreement and diagnostic performance were assessed.
- Keywords
- acute respiratory distress syndrome, diagnostic imaging, computed tomography, chest radiograph, sensitivity, specificity
- Medical subject headings
- Respiratory Distress Syndrome, Hypersensitivity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis.
0 indicates no agreement and 1 indicates perfect agreement
Measured: Baseline
Secondary outcomes (4)
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis in the subgroup of patients with moderate-to-severe hypoxemia
0 indicates no agreement and 1 indicates perfect agreement
Measured: Baseline
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis in the subgroup of immunocompromised patients
0 indicates no agreement and 1 indicates perfect agreement
Measured: Baseline
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis in the subgroup of obese patients
0 indicates no agreement and 1 indicates perfect agreement
Measured: Baseline
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis in the subgroup of patients with 4 quadrants involved on chest radiograph
0 indicates no agreement and 1 indicates perfect agreement
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start1 Jan 2015
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress Syndrome (ARDS)Studies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Retrospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07400445
- Sponsor's protocol ID
- 29084890
- Acronym
- CT 4 ARDS
- Status last verified
- Feb 2026
- First submitted
- 30 Jan 2026
- Last updated
- 10 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable written request to the principal investigator, one year after publication of the main manuscript.
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interobserver Agreement Between Chest Radiograph and Computed Tomography for the Diagnosis of Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT07400445
- Acronym / sponsor ID
- CT 4 ARDS / 29084890
- Keywords
- acute respiratory distress syndrome, diagnostic imaging, computed tomography, chest radiograph, sensitivity, specificity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 10 Feb 2026 (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.
The presence of bilateral lung infiltrates on chest imaging is a mandatory criterion for the diagnosis of acute respiratory distress syndrome (ARDS). This retrospective single-center observational study assessed the agreement between chest radiograph interpreted by intensivists and chest computed tomography interpreted by radiologists for the diagnosis of ARDS in mechanically ventilated patients with hypoxemia. Chest CT was considered the reference standard. The study evaluated interobserver agreement and diagnostic performance of chest radiography in the overall population and in predefined subgroups.
Detailed description
Retrospective, single-center observational study conducted in the medical ICU of University Hospital of Poitiers, France, from January 1, 2015 to December 31, 2021. Included were intubated patients with PaO2/FiO2 ≤ 300 mmHg, PEEP ≥5 cmH2O, suspected ARDS except for imaging criterion, who underwent both chest CT and chest radiograph on the same day. Chest CT was interpreted by radiologists and used as reference for ARDS diagnosis. Chest radiographs were interpreted by intensivists. Agreement and diagnostic performance were assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the medical intensive care unit of the University Hospital of Poitiers
Key inclusion criteria (5 listed)
- Adults admitted to intensive care unit
- Invasive mechanical ventilation
- Chest CT performed during ICU stay
- PaO2/FiO2 ≤ 300 mmHg with positive end-expiratory pressure ≥ 5 cmH2O the day of the CT-scan
- Chest radiograph performed within ± 24h of CT-scan
Key exclusion criteria (2 listed)
- Cardiogenic pulmonary edema as the cause of hypoxemia
- Missing imaging data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis.
Time frame: Baseline
0 indicates no agreement and 1 indicates perfect agreement
4 secondary outcomes
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis in the subgroup of patients with moderate-to-severe hypoxemia
Time frame: Baseline
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis in the subgroup of immunocompromised patients
Time frame: Baseline
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis in the subgroup of obese patients
Time frame: Baseline
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis in the subgroup of patients with 4 quadrants involved on chest radiograph
Time frame: Baseline
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 10 Feb 2026.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable written request to the principal investigator, one year after publication of the main manuscript.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 (ARDS), run by Poitiers University Hospital 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 5 inclusion and 2 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 10 Feb 2026. 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?
Cohen's kappa coefficient for agreement between chest radiograph interpreted by intensivists and chest CT interpreted by radiologists for ARDS diagnosis. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026.