Clinical Trials Logo

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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT03909854 - Pragmatic Investigation of Volume Targeted Ventilation-1 N/A
Recruiting NCT02637011 - Surviving ARDS: The Influence of Quality of Care and Individual Patient Characteristics on Quality of Life N/A
Completed NCT02288949 - Stratification of the Acute Respiratory Distress Syndrome
Recruiting NCT02574169 - Alveolar Recruitment Maneuvers, Intracerebral Hemodynamic and Oxygenation N/A
Completed NCT04548739 - Cerebral Autoregulation in Pediatric ECMO (ECMOX 2)
Terminated NCT04511650 - Evaluation of the Safety and Efficacy of Razuprotafib in Hospitalized Subjects With Coronavirus Disease 2019 Phase 2
Completed NCT05024500 - Clinical and Functional Outcomes of Critically Ill Patients With COVID-19 N/A
Recruiting NCT01339533 - Airway Pressure Release Ventilation (APRV) Versus AC/VC Conventional Ventilation Phase 2
Active, not recruiting NCT01274260 - Trial of Steroids in Pediatric Acute Lung Injury/ARDS Phase 2
Recruiting NCT03296059 - Transfusion of Red Blood Cells for Acute Respiratory Distress Syndrome(ARDS) in Neonates N/A
Recruiting NCT04609865 - Impact of Intravenous Lidocaine on Clinical Outcomes of Patients With ARDS During COVID-19 Pandemia Phase 3
Active, not recruiting NCT04009330 - Clinical Evaluation of a Point of Care (POC) Assay to Identify Phenotypes in the Acute Respiratory Distress Syndrome
Not yet recruiting NCT06127381 - An Open-label Study of the Safety and Pharmacokinetics of the TGKP Phase 1
Not yet recruiting NCT05847517 - Metoprolol in Acute Respiratory Distress Syndrome (MAIDEN) Phase 3
Completed NCT01854424 - Validation of the Percentage of Alveolar Fibrocyte as Biomarker During ARDS N/A
Completed NCT04311697 - Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure Phase 2/Phase 3
Recruiting NCT02095444 - Using Human Menstrual Blood Cells to Treat Acute Lung Injury Caused by H7N9 Bird Flu Virus Infection Phase 1/Phase 2
Recruiting NCT04460859 - RecruitmEnt Assessed by eleCtRical Impedance Tomography
Completed NCT01926093 - Low Dose Lung CT Scan for Quantitative Analysis in ARDS Patients N/A
Terminated NCT01506401 - The Oscillation for Acute Respiratory Distress Syndrome (ARDS) Treated Early (OSCILLATE) Trial Phase 3