Accuracy of the Chest Radiograph for the Diagnosis of Acute Respiratory Distress Syndrome

NCT07400445 | Completed

• 1 other identifier: 29084890
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Keywords

acute respiratory distress syndrome; diagnostic imaging; computed tomography; chest radiograph; sensitivity; specificity

Outcome Measures

Primary Outcomes (1)

• 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

  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

  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

  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

  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

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the medical intensive care unit of the University Hospital of Poitiers

You may qualify if:

• 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

You may not qualify if:

• Cardiogenic pulmonary edema as the cause of hypoxemia
• Missing imaging data

Sponsors & Collaborators

• Poitiers University Hospital: lead

Study Sites (1)

Service de Médecine Intensive Réanimation, University Hospital of Poitiers

Poitiers, France

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Hypersensitivity

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2026
• First Posted: February 10, 2026
• Study Start: January 1, 2015
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2022
• Last Updated: February 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: Start date: one year after publication of the main manuscript End date: two years after publication of the main manuscript

Locations

FR (1)