Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic (QUANTICO-PRO)

Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic : Prospective Multicenter Cohort Study

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 :

1. SARS-CoV-2 infections
2. Postoperative hypoxemic acute respiratory failure.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Failure With Hypoxia; SARS-CoV-2 Infections
• Intervention / Treatment: Radiation: Thoracic CT scan

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eric NOLL, MD PhD; Phone Number: +33 03 88 12 70 76; Email: eric.noll@chru-strasbourg.fr

Study Locations

• France
  • Nancy, France, 54500
    • Not yet recruiting
    • Service d'anesthésie réanimation-CHU de Nancy
    • Contact: Claude MEISTELMAN, MD PhD; Email: c.meistelman@chru-nancy.fr
    • Principal Investigator: Claude MEISTELMAN, MD PhD
    • Sub-Investigator: Valérie CROISE-LAURENT, MD PhD
  • Strasbourg, France, 67098
    • Recruiting
    • Service d'Anesthésie-Réanimation - CHU Strasbourg
    • Contact: Eric NOLL, MD/PhD; Phone Number: 03 88 12 70 76; Email: eric.noll@chru-strasbourg.fr
    • Principal Investigator: Eric NOLL, MD PhD
    • Sub-Investigator: Julien POTTECHER, MD PhD
    • Sub-Investigator: Francis SCHNEIDER, MD PhD
    • Sub-Investigator: Bernard GOICHOT, MD PhD
    • Sub-Investigator: Marie Caroline TAQUET, MD
    • Sub-Investigator: Jean-Etienne HERBRECHT, MD
    • Sub-Investigator: Raphaël CLERE JEHL, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic CT Scan	Radiation: Thoracic CT scan; Automated quantitative analysis of altered pulmonary volume

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 days after CT scan (Day 2)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	7 days after CT scan (Day 7)
Mortality		90 days following CT scan (Day 90)
Rate of admission to intensive care unit		28 days following CT scan (Day 28)
Initial length of hospitalization stay (in days)		90 days following CT scan (Day 90)

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Collaborators: REGION GRAND EST; E-MEDIA; VISIBLE PATIENT

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2022
• Primary Completion (Anticipated): April 1, 2025
• Study Completion (Anticipated): June 1, 2025

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: March 11, 2022
• First Posted (Actual): March 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Signs and Symptoms, Respiratory; COVID-19; Respiratory Insufficiency; Hypoxia
• Other Study ID Numbers: 8138

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No