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

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ClinicalTrials.gov Identifier: NCT03870009
Recruitment Status : Recruiting
First Posted : March 11, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome (ARDS) Other: ARDS patients Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: 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
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

Other Name: CT measurements




Primary Outcome Measures :
  1. cyclic hyperinflation measured by manual segmentation [ Time Frame: 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

  2. cyclic hyperinflation measured by semi-automated segmentation [ Time Frame: 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 :
  1. prevalence of cyclic hyperinflation on CT scan [ Time Frame: 2 hours after inclusion ]
    cyclic hyperinflation assessed by manual segmentation on CT scan

  2. area under receiver operating characteristic (ROC) curve of respiratory system driving pressure to detect cyclic hyperinflation assessed by manual segmentation [ Time Frame: 2 hours after inclusion ]
  3. area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation [ Time Frame: 2 hours after inclusion ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03870009


Contacts
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Contact: Jean Christophe Richard 4 26 10 92 72 ext +33 j-christophe.richard@chu-lyon.fr

Locations
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France
Croix Rousse Hospital Recruiting
Lyon, France, 69004
Contact: Jean Christophe Richard, Pr    4 26 10 92 72 ext +33    j-christophe.richard@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jean Christophe Richard Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03870009     History of Changes
Other Study ID Numbers: 69HCL18_1001
2019-A00024-53 ( Other Identifier: ANSM )
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
ARDS
computed tomography
cyclic hyperinflation
mechanical ventilation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury