COVID-19 : Pulmonary Ultrasound in Primary Care

Completed

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

• Registration Number: NCT05226403
• Lead Sponsor: Geprovas

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-01
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Study First Submitted: 2022-01-26
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-04
• Last Update Submitted: 2022-02-04
• Study First Posted: 2022-02-07
• Last Update Posted: 2022-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound Signs	Between day 5 and day 10 of infection	Frequency of the presence of at least one ultrasound sign in the subjects included

Secondary Outcome Measures

Name	Time	Method
Evolution and complication	Day 14 of infection	Number of deaths and patients admitted to hospital for worsening of respiratory signs of infection
Clinical Signs	Day 5 and Day 10	Clinical signs positives in the cas of presence one of these elements: Hypoxia, Tachypnée, Pathological pulmonary auscultation.
Ultrasound signs	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.

Trial Locations

Locations (1)

GEPROVAS; 🇫🇷 Strasbourg, France