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

Not Applicable

Recruiting

• Conditions: SARS-CoV-2 Infections; Respiratory Failure With Hypoxia
• Interventions: Radiation: Thoracic CT scan

• Registration Number: NCT05278390
• Lead Sponsor: University Hospital, Strasbourg, France

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 :

1. SARS-CoV-2 infections

2. Postoperative hypoxemic acute respiratory failure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-11
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-14
• Status Verified: 2022-06
• Study Start: 2022-06-13
• Last Update Submitted: 2022-06-23
• Last Update Posted: 2022-06-30
• Primary Completion: 2025-04
• Study Completion: 2025-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Thoracic CT Scan	Thoracic CT scan	-

Primary Outcome Measures

Name	Time	Method
Correlation between altered pulmonary volume and ordinal severity scale	2 days after CT scan (Day 2)	This criterion will be expressed as a score between 1 (least severe) and 7 (most severe).

Secondary Outcome Measures

Name	Time	Method
Mortality	90 days following CT scan (Day 90)
Initial length of hospitalization stay (in days)	90 days following CT scan (Day 90)
Rate of admission to intensive care unit	28 days following CT scan (Day 28)
Correlation between altered pulmonary volume and ordinal severity scale	7 days after CT scan (Day 7)	This criterion will be expressed as a score between 1 (least severe) and 7 (most severe).

Trial Locations

Locations (2)

Service d'anesthésie réanimation-CHU de Nancy; 🇫🇷 Nancy, France

Service d'Anesthésie-Réanimation - CHU Strasbourg; 🇫🇷 Strasbourg, France