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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • France
      • Poitiers, France
        • Service de Médecine Intensive Réanimation, University Hospital of Poitiers

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poitiers University Hospital

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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