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

Civil Hospices of Lyon

Status: Completed

Conditions: Acute Respiratory Distress Syndrome (ARDS)

Treatments: Other: ARDS patients

Study type: Interventional

Funder types: Other

Identifiers

NCT03870009

69HCL18_1001

2019-A00024-53 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

ARDS patients

Experimental group

Description:

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

Treatment:

Other: ARDS patients