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

Respiratory Failure With Hypoxia Clinical Trial

— QUANTICO-PRO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05278390
• Other study ID #: 8138
• Status: Recruiting
• Phase: N/A
• Start date: June 13, 2022
• Est. completion date: June 2025

Study information

• Verified date: June 2022
• Source: University Hospital, Strasbourg, France
• Contact: Eric NOLL, MD PhD
• Phone: 03 88 12 70 76
• Email: eric.noll[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Hypoxia
• Respiratory Failure With Hypoxia
• Respiratory Insufficiency
• SARS-CoV-2 Infections

Intervention

Radiation:
• Thoracic CT scan
Automated quantitative analysis of altered pulmonary volume

Locations

Country	Name	City	State
France	Service d'anesthésie réanimation-CHU de Nancy	Nancy
France	Service d'Anesthésie-Réanimation - CHU Strasbourg	Strasbourg

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France	E-MEDIA, REGION GRAND EST, VISIBLE PATIENT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Mortality		90 days following CT scan (Day 90)
Secondary	Rate of admission to intensive care unit		28 days following CT scan (Day 28)
Secondary	Initial length of hospitalization stay (in days)		90 days following CT scan (Day 90)