Automated Quantification of Radiologic Pulmonary Alterati... | NCT04534400

Studies
Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure

NCT04534400

Sponsor

University Hospital, Strasbourg, France

Status

Unknown status

Last Update Posted

Apr 18, 2023Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

SARS-CoV-2 Infection
Respiratory Failure With Hypoxia

Interventions

thoracic CT-scan

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2020Actual

Primary Completion Date

Mar 1, 2024Estimated

Completion Date

Mar 1, 2024Estimated

First Submitted Date

Aug 26, 2020

First Submission Date that Met QC Criteria

Aug 26, 2020

First Posted Date

Sep 1, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2023

Last Update Posted Date

Apr 18, 2023Actual

Name	Class
VISIBLE PATIENT, E-MEDIA	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 aim 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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with SARS-CoV-2 infection			Radiation: thoracic CT-scan
Patients with Postoperative hypoxemic respiratory failure			Radiation: thoracic CT-scan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
thoracic CT-scan	Radiation	Automated measurement	Patients with Postoperative hypoxemic respiratory failure Patients with SARS-CoV-2 infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between altered pulmonary volume and ordinal severity scale		2 days after CT scan

Secondary Outcomes

Measure	Description	Time Frame
Correlation between altered pulmonary volume and ordinal severity scale		7 days after CT scan

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patient with insurance covering
patient admitted to the participating hospitals for SARS-CoV-2 infection or postoperative acute hypoxemic respiratory failure between 01/01/2019 and 05/11/2020

Exclusion Criteria:

- patient transferred to another hospital than the participating center during the 7 days following the CT scan

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hospitalized patients that underwent a thoracic CT-scan

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eric NOLL, MD	Contact	33388127076		eric.noll@chru-strasbourg.fr
Pierre DIEMUNSCH, MD	Contact	33388125720		pierre.diemunsch@chru-strasbourg.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
HÔPITAUX UNIVERSITAIRES DE STRASBOURG, Hôpital de Hautepierre, Service de Réanimation Médicale	Recruiting	Strasbourg		67098	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Eric NOLL, MDContact33388127076eric.noll@chru-strasbourg.fr
Pierre DIEMUNSCH, MDContact33388125720pierre.diemunsch@chru-strasbourg.fr
Eric NOLL, MDPrincipal Investigator
Pierre DIEMUNSCH, MDSub-Investigator
Julien POTTECHER, MDSub-Investigator
Francis VEILLON, MDSub-Investigator
Mickaël OHANA, MDSub-Investigator
Francis SCHNEIDER, MDSub-Investigator
Bernard GOICHOIT, MDSub-Investigator