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

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome (ARDS)
• Interventions: Other: ARDS patients

• Registration Number: NCT03870009
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-08
• Study First Submitted QC: 2019-03-08
• Study First Posted: 2019-03-11
• Study Start: 2019-05-21
• Primary Completion: 2021-02-16
• Study Completion: 2021-02-16
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-29
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARDS patients	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

Primary Outcome Measures

Name	Time	Method
cyclic hyperinflation measured by semi-automated segmentation	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
cyclic hyperinflation measured by manual segmentation	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 Outcome Measures

Name	Time	Method
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
prevalence of cyclic hyperinflation on CT scan	2 hours after inclusion	cyclic hyperinflation assessed by manual segmentation on CT scan

Trial Locations

Locations (1)

Croix Rousse Hospital; 🇫🇷 Lyon, France