Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS (CT4-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.

Study Overview

• Status: Completed
• Conditions: Acute Respiratory Distress Syndrome (ARDS)
• Intervention / Treatment: Other: ARDS patients

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Croix Rousse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARDS patients; All the patients will be evaluated with the same procedure, as the study relates to evaluation of the diagnostic performance of a semi-automated method to detect cyclic hyperinflation on CT scan	Other: ARDS patients; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
cyclic hyperinflation measured by manual segmentation	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 hours after inclusion
cyclic hyperinflation measured by semi-automated segmentation	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 hours after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
prevalence of cyclic hyperinflation on CT scan	cyclic hyperinflation assessed by manual segmentation on CT scan	2 hours after inclusion
area under receiver operating characteristic (ROC) curve of respiratory system driving pressure to detect cyclic hyperinflation assessed by manual segmentation		2 hours after inclusion
area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation		2 hours after inclusion

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Jean Christophe RICHARD, Hospices Civils de Lyon

Publications and helpful links

General Publications

• E. Dávila Serrano, François Dhelft, Laurent Bitker, Jean-Christophe Richard, Maciej Orkisz. Software for CT-image Analysis to Assist the Choice of Mechanical-ventilation Settings in Acute Respiratory Distress Syndrome. 2020 International Conference on Computer Vision and Graphics (ICCVG 2020), Sep 2020, Varsovie, Poland. ff10.1007/978-3-030-59006-2_5ff. ffhal-02887264

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2019
• Primary Completion (Actual): February 16, 2021
• Study Completion (Actual): February 16, 2021

Study Registration Dates

• First Submitted: March 8, 2019
• First Submitted That Met QC Criteria: March 8, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 20, 2025
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: mechanical ventilation; ARDS; computed tomography; cyclic hyperinflation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Infant, Premature, Diseases; Infant, Newborn, Diseases; Lung Injury; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 69HCL18_1001; 2019-A00024-53 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No