Back to resultsAutomated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic (QUANTICO-PRO)
Primary Purpose
SARS-CoV-2 Infections, Respiratory Failure With Hypoxia
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Thoracic CT scan
Sponsored by
About this trial
This is an interventional diagnostic trial for SARS-CoV-2 Infections
Eligibility Criteria
Inclusion Criteria:
- Subject admitted to a care unit of the University Hospitals of Strasbourg or the University Hospital of Nancy and presenting a suspicion of SARS-CoV-2 infection or postoperative hypoxemic respiratory failure
- Able to understand the objectives and risks of the research and to give dated and signed informed consent.
Subjects may also be included in emergency or immediate life-threatening situations.
- Subject with insurance covering
Exclusion Criteria:
- Pregnant woman (pregnancy confirmed by a urine or blood test)
- Subject usually on home oxygen therapy
- Subject under court protection
- Subject under guardianship or curatorship
Sites / Locations
- Service d'anesthésie réanimation-CHU de Nancy
- Service d'Anesthésie-Réanimation - CHU StrasbourgRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Thoracic CT Scan
Arm Description
Outcomes
Primary Outcome Measures
Correlation between altered pulmonary volume and ordinal severity scale
This criterion will be expressed as a score between 1 (least severe) and 7 (most severe).
Secondary Outcome Measures
Correlation between altered pulmonary volume and ordinal severity scale
This criterion will be expressed as a score between 1 (least severe) and 7 (most severe).
Mortality
Rate of admission to intensive care unit
Initial length of hospitalization stay (in days)
Full Information
NCT ID
NCT05278390
First Posted
March 11, 2022
Last Updated
June 23, 2022
Sponsor
University Hospital, Strasbourg, France
Collaborators
REGION GRAND EST, E-MEDIA, VISIBLE PATIENT
1. Study Identification
Unique Protocol Identification Number
NCT05278390
Brief Title
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
Acronym
QUANTICO-PRO
Official Title
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic : Prospective Multicenter Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2022 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Strasbourg, France
Collaborators
REGION GRAND EST, E-MEDIA, VISIBLE PATIENT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Automated quantification of the pulmonary volume impaired during acute respiratory failure could be helpful to assess patient severity during COVID-19 infection or perioperative medicine, for example.
This study aims at assessing the correlation between the amount of radiologic pulmonary alteration and the clinical severity in two clinical situation :
SARS-CoV-2 infections
Postoperative hypoxemic acute respiratory failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS-CoV-2 Infections, Respiratory Failure With Hypoxia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thoracic CT Scan
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
Thoracic CT scan
Intervention Description
Automated quantitative analysis of altered pulmonary volume
Primary Outcome Measure Information:
Title
Correlation between altered pulmonary volume and ordinal severity scale
Description
This criterion will be expressed as a score between 1 (least severe) and 7 (most severe).
Time Frame
2 days after CT scan (Day 2)
Secondary Outcome Measure Information:
Title
Correlation between altered pulmonary volume and ordinal severity scale
Description
This criterion will be expressed as a score between 1 (least severe) and 7 (most severe).
Time Frame
7 days after CT scan (Day 7)
Title
Mortality
Time Frame
90 days following CT scan (Day 90)
Title
Rate of admission to intensive care unit
Time Frame
28 days following CT scan (Day 28)
Title
Initial length of hospitalization stay (in days)
Time Frame
90 days following CT scan (Day 90)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject admitted to a care unit of the University Hospitals of Strasbourg or the University Hospital of Nancy and presenting a suspicion of SARS-CoV-2 infection or postoperative hypoxemic respiratory failure
Able to understand the objectives and risks of the research and to give dated and signed informed consent.
Subjects may also be included in emergency or immediate life-threatening situations.
Subject with insurance covering
Exclusion Criteria:
Pregnant woman (pregnancy confirmed by a urine or blood test)
Subject usually on home oxygen therapy
Subject under court protection
Subject under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric NOLL, MD PhD
Phone
03 88 12 70 76
Ext
+33
Email
eric.noll@chru-strasbourg.fr
Facility Information:
Facility Name
Service d'anesthésie réanimation-CHU de Nancy
City
Nancy
ZIP/Postal Code
54500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claude MEISTELMAN, MD PhD
Email
c.meistelman@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Claude MEISTELMAN, MD PhD
First Name & Middle Initial & Last Name & Degree
Valérie CROISE-LAURENT, MD PhD
Facility Name
Service d'Anesthésie-Réanimation - CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric NOLL, MD/PhD
Phone
03 88 12 70 76
Email
eric.noll@chru-strasbourg.fr
First Name & Middle Initial & Last Name & Degree
Eric NOLL, MD PhD
First Name & Middle Initial & Last Name & Degree
Julien POTTECHER, MD PhD
First Name & Middle Initial & Last Name & Degree
Francis SCHNEIDER, MD PhD
First Name & Middle Initial & Last Name & Degree
Bernard GOICHOT, MD PhD
First Name & Middle Initial & Last Name & Degree
Marie Caroline TAQUET, MD
First Name & Middle Initial & Last Name & Degree
Jean-Etienne HERBRECHT, MD
First Name & Middle Initial & Last Name & Degree
Raphaël CLERE JEHL, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
We'll reach out to this number within 24 hrs