- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07400445
Accuracy of the Chest Radiograph for the Diagnosis of Acute Respiratory Distress Syndrome (CT 4 ARDS)
February 6, 2026 updated by: Poitiers University Hospital
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
277
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
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Poitiers, France
- Service de Médecine Intensive Réanimation, University Hospital of Poitiers
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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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients admitted to the medical intensive care unit of the University Hospital of Poitiers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Cardiogenic pulmonary edema as the cause of hypoxemia
- Missing imaging data
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
0 indicates no agreement and 1 indicates perfect agreement
|
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
|
0 indicates no agreement and 1 indicates perfect agreement
|
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
|
0 indicates no agreement and 1 indicates perfect agreement
|
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
|
0 indicates no agreement and 1 indicates perfect agreement
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2015
Primary Completion (Actual)
January 31, 2022
Study Completion (Actual)
January 31, 2022
Study Registration Dates
First Submitted
January 30, 2026
First Submitted That Met QC Criteria
February 6, 2026
First Posted (Actual)
February 10, 2026
Study Record Updates
Last Update Posted (Actual)
February 10, 2026
Last Update Submitted That Met QC Criteria
February 6, 2026
Last Verified
February 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 29084890
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data will be available on reasonable written request to the principal investigator, one year after publication of the main manuscript.
IPD Sharing Time Frame
Start date: one year after publication of the main manuscript End date: two years after publication of the main manuscript
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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