COVID-19 : Pulmonary Ultrasound in Primary Care (ECHOVID-MG)

Descriptive Study of Clinical and Pulmonary Ultrasound Signs of Acute Respiratory Infections Associated With COVID-19 in Primary Care

COVID-19 infection are characterized by fever and signs of acute respiratory infection. A worsening of respiratory symptoms that can lead to respiratory failure. The decompensation can then be brutal and require rapid recourse to respiratory assistance. The contribution of clinical examination (auscultation and monitoring of oxygen saturation in particular) remains unsatisfactory in predicting an unfavorable course. The interest of pulmonary ultrasound is known in the management of pulmonary infections. However, estimating the severity of lung damage at an early stage could be of great help in monitoring and caring for patients. Ultrasound could meet this need in general practice, the chest scanner is often unavailable in these situations.

Ultrasound signs are associated with severe forms. The contribution of pulmonary ultrasound seems particularly interesting in the context of the reassessment of patients during the worsening phase of symptoms (D5-D10).

Estimate the prevalence of ultrasound signs in patients with an acute respiratory infection suspected or confirmed to be COVID-19, at the time of the worsening phase (between D5 and D10 of the onset of symptoms).

The prevalence of ultrasound lung lesions under COVID-19 may be essential to consider the development of the ultrasound tool in primary care. Indeed, if the contribution of ultrasound is now recognized in intensive care or emergency, its place in general medicine still raises questions.

Study Overview

• Status: Completed
• Conditions: Covid19; Ultrasound Therapy; Complications; Respiratory Infection; Pulmonary Infection

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• France
  • Strasbourg, France, 67000
    • GEPROVAS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with acute respiratory infection linked to COVID-19

Description

Inclusion Criteria:

1. Patients over 18 years of age with :

   • a clinical symptomatology suggesting an acute respiratory infection linked to COVID-19 defined by the following two categories of symptoms:

     • Sudden fever (or a feeling of fever)
     • Respiratory signs (cough, dyspnea, chest tightness) Or
   • an acute respiratory infection confirmed to COVID-19 by the result of RT-PCR screening tests.

2. And presenting, at the time of inclusion between the 5th and 10th day of infection, one of the respiratory signs of severity felt:

   • Dyspnea, shortness of breath or difficulty in breathing
   • Chest pain or tightness

Exclusion Criteria:

1. The presence of a severe form during the initial consultation. A severe form is defined by the presence of the following signs:

   • Polypnea> 22 / min
   • systolic BP <90 mmHg
   • Sp02 <90%
   • Altered consciousness, confusion, drowsiness
   • Dehydration
   • Alteration of the general condition in the elderly
2. The presence of acute respiratory signs clearly having a cause other than a COVID-19 infection.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasound Signs	Frequency of the presence of at least one ultrasound sign in the subjects included	Between day 5 and day 10 of infection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Signs	Clinical signs positives in the cas of presence one of these elements: Hypoxia, Tachypnée, Pathological pulmonary auscultation.	Day 5 and Day 10
Ultrasound signs	Ultrasound signs positives in the case of presence one of these elements: Disappearance of lines A, Appearance of three lines B, Appearance of pulmonary condensation.	Between day 5 and day 10
Evolution and complication	Number of deaths and patients admitted to hospital for worsening of respiratory signs of infection	Day 14 of infection

Collaborators and Investigators

• Sponsor: Geprovas

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 4, 2022
• First Posted (Actual): February 7, 2022

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: COVID19
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; COVID-19; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 2020-A01225-34

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No