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

Primary Purpose

Acute Respiratory Distress Syndrome (ARDS)

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
ARDS patients
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Acute Respiratory Distress Syndrome (ARDS) focused on measuring ARDS, computed tomography, cyclic hyperinflation, mechanical ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Croix Rousse Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARDS patients

Arm 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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

prevalence of cyclic hyperinflation on CT scan
cyclic hyperinflation assessed by manual segmentation on CT scan
area under receiver operating characteristic (ROC) curve of respiratory system driving pressure to detect cyclic hyperinflation assessed by manual segmentation
area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation

Full Information

First Posted
March 8, 2019
Last Updated
August 29, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT03870009
Brief Title
Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS
Acronym
CT4-ARDS
Official Title
Validation of a Semi-automatized Method to Detect Cyclic Hyperinflation on CT-scan in ARDS
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 21, 2019 (Actual)
Primary Completion Date
February 16, 2021 (Actual)
Study Completion Date
February 16, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome (ARDS)
Keywords
ARDS, computed tomography, cyclic hyperinflation, mechanical ventilation

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARDS patients
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
ARDS patients
Other Intervention Name(s)
CT measurements
Intervention Description
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
Primary Outcome Measure Information:
Title
cyclic hyperinflation measured by manual segmentation
Description
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
Time Frame
2 hours after inclusion
Title
cyclic hyperinflation measured by semi-automated segmentation
Description
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
Time Frame
2 hours after inclusion
Secondary Outcome Measure Information:
Title
prevalence of cyclic hyperinflation on CT scan
Description
cyclic hyperinflation assessed by manual segmentation on CT scan
Time Frame
2 hours after inclusion
Title
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
Title
area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation
Time Frame
2 hours after inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Christophe Richard
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croix Rousse Hospital
City
Lyon
ZIP/Postal Code
69004
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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