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NCT Number: NCT07400445

Accuracy of the Chest Radiograph 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.

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Key information

Conditions

Acute Respiratory Distress Syndrome (ARDS) Hypersensitivity Immune System Diseases Lung Diseases Respiration Disorders Respiratory Distress Syndrome Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service de Médecine Intensive Réanimation, University Hospital of Poitiers

Poitiers, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  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 4 quadrants involved on chest radiograph

    Time frame: Baseline

    0 indicates no agreement and 1 indicates perfect agreement

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Interobserver Agreement Between Chest Radiograph and Computed Tomography for the Diagnosis of Acute Respiratory Distress Syndrome

Acronym: CT 4 ARDS

Important dates

Study start
2015
Primary completion
2022
Study completion
2022
First posted
Feb 10, 2026
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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