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

NCT ID: NCT03870009

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2021-02-16

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome (ARDS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

ARDS patients

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

CT measurements

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Christophe Richard

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

Croix Rousse Hospital

Lyon, , France

Countries

France

References

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

Reference Type: RESULT

Other Identifiers

2019-A00024-53

Identifier Type: OTHER

Identifier Source: secondary_id

69HCL18_1001

Identifier Type: -

Identifier Source: org_study_id