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Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure (QUANTICO-RETRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04534400
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : September 3, 2020
Sponsor:
Collaborator:
VISIBLE PATIENT, E-MEDIA
Information provided by (Responsible Party):
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 aim 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

Condition or disease Intervention/treatment
SARS-CoV-2 Infection Respiratory Failure With Hypoxia Radiation: thoracic CT-scan

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Automated Quantification of Radiologic Pulmonary Alteration During Acute Respiratory Failure: Application to the COVID-19 Pandemic
Estimated Study Start Date : September 1, 2020
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with SARS-CoV-2 infection Radiation: thoracic CT-scan
Automated measurement

Patients with Postoperative hypoxemic respiratory failure Radiation: thoracic CT-scan
Automated measurement




Primary Outcome Measures :
  1. Correlation between altered pulmonary volume and ordinal severity scale [ Time Frame: 2 days after CT scan ]

Secondary Outcome Measures :
  1. Correlation between altered pulmonary volume and ordinal severity scale [ Time Frame: 7 days after CT scan ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Hospitalized patients that underwent a thoracic CT-scan
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04534400


Contacts
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Contact: Eric NOLL, MD 33388127076 eric.noll@chru-strasbourg.fr
Contact: Pierre DIEMUNSCH, MD 33388125720 pierre.diemunsch@chru-strasbourg.fr

Locations
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France
GHR MULHOUSE-SUD ALSACE, Hôpital Emile Muller, Service de Radiologie Not yet recruiting
Mulhouse, France, 68100
Contact: Philippe FEUERSTEIN, MD    33389646464    philippe.feuerstein@ghrmsa.fr   
Principal Investigator: Philippe FEUERSTEIN, MD         
HÔPITAUX UNIVERSITAIRES DE STRASBOURG, Hôpital de Hautepierre, Service de Réanimation Médicale Recruiting
Strasbourg, France, 67098
Contact: Eric NOLL, MD    33388127076    eric.noll@chru-strasbourg.fr   
Contact: Pierre DIEMUNSCH, MD    33388125720    pierre.diemunsch@chru-strasbourg.fr   
Principal Investigator: Eric NOLL, MD         
Sub-Investigator: Pierre DIEMUNSCH, MD         
Sub-Investigator: Julien POTTECHER, MD         
Sub-Investigator: Francis VEILLON, MD         
Sub-Investigator: Mickaël OHANA, MD         
Sub-Investigator: Francis SCHNEIDER, MD         
Sub-Investigator: Bernard GOICHOIT, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
VISIBLE PATIENT, E-MEDIA
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04534400    
Other Study ID Numbers: 7888
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Respiratory Insufficiency
Hypoxia
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory