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NCT Number: NCT05226403

COVID-19 : Pulmonary Ultrasound 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.

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Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral Pulmonary Infection RNA Virus Infections Respiratory Infection Respiratory Tract Diseases Respiratory Tract Infections Ultrasound Therapy; Complications Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GEPROVAS

Strasbourg, 67000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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
  • The presence of acute respiratory signs clearly having a cause other than a COVID-19 infection.

Treatment and study plan

Primary outcomes

  1. Ultrasound Signs

    Time frame: Between day 5 and day 10 of infection

    Frequency of the presence of at least one ultrasound sign in the subjects included

Secondary outcomes

  1. Clinical Signs

    Time frame: Day 5 and Day 10

    Clinical signs positives in the cas of presence one of these elements: Hypoxia, Tachypnée, Pathological pulmonary auscultation.

  2. Ultrasound signs

    Time frame: Between day 5 and day 10

    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.

  3. Evolution and complication

    Time frame: Day 14 of infection

    Number of deaths and patients admitted to hospital for worsening of respiratory signs of infection

Sponsors and collaborators

Lead sponsor

Geprovas

Network

Registry information

Official study title

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

Acronym: ECHOVID-MG

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 7, 2022
Registry last updated
Feb 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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