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OpenTrials
Completed

NCT Number: NCT03870009

Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS

This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients.

The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Croix Rousse Hospital

Lyon, 69004, France

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ARDS patients defined by the Berlin definition
  • invasive mechanical ventilation with an arterial oxygen pressure (PaO2)/inspired fraction of oxygen (FiO2) ratio ≤ 200 mm Hg
  • Indication of CT scan identified by the clinician in charge
  • oesophageal catheter already inserted

Exclusion criteria

  • requirement of contrast agent for a chest CT-scan
  • ARDS criteria present for more than 72 hours
  • Chronic Obstructive Pulmonary Disease (COPD) on a previous lung function test
  • pneumothorax or bronchopleural fistula
  • patient without both sedation and neuromuscular blocking agents
  • contra-indication to transport to the imaging facility
  • treatment with extracorporeal membrane oxygenation or extracorporeal carbon dioxide (CO2) removal
  • Latex or curare allergy
  • patient previously included in the study
  • pregnancy
  • patient under limitation of care
  • patient under an exclusion period following inclusion in another clinical trial
  • patient under a legal protective measure
  • patient unaffiliated with social security
  • inform consent not obtained by next of kin

Treatment and study plan

ARDS patients

Other

The patient will be installed on the scanner bed. Two series of tomographic sections will be acquired: one during an expiratory break, the other during an inspiratory pause.

cyclic hyperinflation measured by semi-automatic segmentation and by manual segmentation

Other names: CT measurements

Primary outcomes

  1. cyclic hyperinflation measured by manual segmentation

    Time frame: 2 hours after inclusion

    Bias and precision of semi-automated measure will be assessed with the Bland and Altman Technique, using cyclic hyperinflation by manual segmentation as a reference

  2. cyclic hyperinflation measured by semi-automated segmentation

    Time frame: 2 hours after inclusion

    Bias and precision of semi-automated measure will be assessed with the Bland and Altman Technique, using cyclic hyperinflation by manual segmentation as a reference

Secondary outcomes

  1. prevalence of cyclic hyperinflation on CT scan

    Time frame: 2 hours after inclusion

    cyclic hyperinflation assessed by manual segmentation on CT scan

  2. area under receiver operating characteristic (ROC) curve of respiratory system driving pressure to detect cyclic hyperinflation assessed by manual segmentation

    Time frame: 2 hours after inclusion

  3. area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation

    Time frame: 2 hours after inclusion

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Acronym: CT4-ARDS

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 11, 2019
Registry last updated
Aug 22, 2025

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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