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

NCT03870009 | Completed

• 2 other identifiers: 69HCL18_10012019-A00024-53
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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)

Keywords

ARDS; computed tomography; cyclic hyperinflation; mechanical ventilation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• prevalence of cyclic hyperinflation 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

Study Arms (1)

ARDS patients

EXPERIMENTAL

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

Interventions

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

Also known as: CT measurements

ARDS patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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 a legal protective measure
• patient unaffiliated with social security
• inform consent not obtained by next of kin

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Croix Rousse Hospital

Lyon, 69004, France

Location

Related Publications (1)

• 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

  RESULT

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Jean Christophe Richard

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2019
• First Posted: March 11, 2019
• Study Start: May 21, 2019
• Primary Completion: February 16, 2021
• Study Completion: February 16, 2021
• Last Updated: August 22, 2025

Record last verified: 2022-08

Locations

FR (1)