Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid (Coronavirus Disease) 19

• ClinicalTrials.gov Identifier: NCT04341766
• Recruitment Status: Completed
• First Posted: April 10, 2020
• Last Update Posted: July 17, 2020
• Sponsor: Centre Hospitalier Intercommunal Creteil
• Information provided by (Responsible Party): Centre Hospitalier Intercommunal Creteil

Tracking Information

• First Submitted Date: April 1, 2020
• First Posted Date: April 10, 2020
• Last Update Posted Date: July 17, 2020
• Actual Study Start Date: March 31, 2020
• Actual Primary Completion Date: May 27, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2020)

Characteristics of pulmonary ultrasound for Covid-19 patients [ Time Frame: Day one ]

description of ultrasound abnormalities for Covid-19 patients

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 9, 2020)

• Characteristics of pulmonary ultrasound for Covid-19 patients [ Time Frame: Day 3 ]
  description of ultrasound abnormalities for Covid-19 patients
• Characteristics of pulmonary ultrasound for Covid-19 patients [ Time Frame: Day 14 ]
  description of ultrasound abnormalities for Covid-19 patients
• Charateristics of pulmonary CT-scan for Covid-19 patients [ Time Frame: Day 1 ]
  description of CT-scan abnormalities for Covid-19 patients
• Charateristics of pulmonary CT-scan for Covid-19 patients [ Time Frame: Day 3 ]
  description of CT-scan abnormalities for Covid-19 patients
• Charateristics of pulmonary CT-scan for Covid-19 patients [ Time Frame: Day 14 ]
  description of CT-scan abnormalities for Covid-19 patients

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid (Coronavirus Disease) 19
• Official Title: Prospective Descriptive Study on the Evolution of Pulmonary Ultrasound in Patients Hospitalized for Covid19

Brief Summary

Clinical thoracic ultrasound plays an important role in the exploration, diagnosis and follow-up of thoracic pathologies.

The COVID (Coronavirus Disease) epidemic is leading to a large influx of patients in the emergency department with respiratory disorders. The rapid diagnosis of respiratory disorders in infected patients is important for further management.

Chest ultrasound has already demonstrated its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray.

However, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.

Detailed Description

Chest ultrasound has already shown its value in the diagnosis of pneumonia in the emergency department with superiority over chest X-ray.

However, there is little data on the thoracic ultrasound semiology of viral pneumonia in general and of COVID in particular.

Peng reported data from 20 patients and compared them to chest CT. The abnormalities are a thickening of the pleuropneumonia line, an interstitial syndrome with B lines, corresponding to frosted glass opacities, confluent B lines (snowstorm appearance) corresponding to interstitial infiltrate, sub-pleural alveolar opacities corresponding to sub-pleural condensations, more frank alveolar images corresponding to alveolar opacities. A multifocal aspect was associated with involvement of more than 2 lobes. However, the frequency of these abnormalities as well as the sensitivity of the echo are not detailed in this article.

Another Italian article describes a clinical case of COVID-19 pneumonia with sub-pleural involvement and irregularity of the pleuro-pulmonary line.

Clinical thoracic ultrasound has a major potential interest during the COVID epidemic: available at the patient's bedside, avoiding the need to move around, feasible for the physician during his visit, easy to clean especially if ultraportable devices are used, fast and not exposing the staff any more than the usual clinical examination.

In order to determine whether this technique is useful in the management of infected patients or patients suspected of COVID-19 infection with respiratory signs, we propose a descriptive prospective study evaluating the ultrasound semiology of COVID-19 pneumonia and the interest of ultrasound in the evolutionary follow-up of these patients.

• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: 6 Weeks
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patient admitted to hospital with proven COVID-19 infection with respiratory signs and who need an hospitalization

Condition

• Pneumonia, Viral
• COVID-19

Intervention

Other: No special intervention

No special intervention : Ultrasound data will be collected

Study Groups/Cohorts

Patient hospitalised with COVID-19 infection

Patients admitted to hospital with proven COVID-19 infection with respiratory signs warranting a chest CT scan

Intervention: Other: No special intervention

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 16, 2020): 106
• Original Estimated Enrollment (submitted: April 9, 2020): 200
• Actual Study Completion Date: June 30, 2020
• Actual Primary Completion Date: May 27, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients admitted to hospital with proven COVID-19 infection with respiratory signs warranting a chest CT scan

Exclusion Criteria:

• Patient not agreeing to have his or her data collected for the study
• Unconscious patient

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 105 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT04341766
• Other Study ID Numbers: COVID-ECHO
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Centre Hospitalier Intercommunal Creteil
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre Hospitalier Intercommunal Creteil
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Centre Hospitalier Intercommunal Creteil
• Verification Date: July 2020