Clinical trial NCT05226403: COVID-19 : Pulmonary Ultrasound in Primary Care
Official title: Descriptive Study of Clinical and Pulmonary Ultrasound Signs of Acute Respiratory Infections Associated With COVID-19 in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Pulmonary Infection
Ultrasound Therapy; Complications
Respiratory Infection
Keywords: COVID19
Lead sponsor: Geprovas
Sponsor class: NETWORK
First posted: 2022-02-07
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with acute respiratory infection linked to COVID-19

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasound Signs
timeFrame: Between day 5 and day 10 of infection
Secondary outcomes:
measure: Clinical Signs
timeFrame: Day 5 and Day 10
measure: Ultrasound signs
timeFrame: Between day 5 and day 10
measure: Evolution and complication
timeFrame: Day 14 of infection
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: GEPROVAS
Study officials:
References: