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

Acute Respiratory Distress Syndrome (ARDS) Clinical Trial

— CT4-ARDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870009
• Other study ID #: 69HCL18_1001
• Secondary ID: 2019-A00024-53
• Status: Completed
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: February 16, 2021

Study information

• Verified date: August 2022
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: February 16, 2021
• Est. primary completion date: February 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome (ARDS)
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
France	Croix Rousse Hospital	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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