NCT05278390

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 11, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 14, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

June 13, 2022

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

June 30, 2022

Status Verified

June 1, 2022

Enrollment Period

2.8 years

First QC Date

March 11, 2022

Last Update Submit

June 23, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Correlation between altered pulmonary volume and ordinal severity scale

    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)

Study Arms (1)

Thoracic CT Scan

EXPERIMENTAL
Radiation: Thoracic CT scan

Interventions

Automated quantitative analysis of altered pulmonary volume

Thoracic CT Scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service d'anesthésie réanimation-CHU de Nancy

Nancy, 54500, France

NOT YET RECRUITING

Service d'Anesthésie-Réanimation - CHU Strasbourg

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 14, 2022

Study Start

June 13, 2022

Primary Completion

April 1, 2025

Study Completion

June 1, 2025

Last Updated

June 30, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations