Reliability of Standardized Protocol of Ultrasound of the Lungs in Prediction of Severity of Covid-19 Infection

Jagiellonian University

Status: Completed

Conditions: Covid19

Study type: Observational

Funder types: Other

Identifiers

NCT04513210

JagiellonianU67

Details and patient eligibility

About

Ultrasound can reliably detect morphologic changes associated with pneumonia. Additionally, protocols were elaborated which unify the investigation procedure and improve the intra- and interrater reliability. Moreover, ultrasound is a time and cost-effective and widely available method. The aim of this study is to evaluate the efficacy of the ultrasound of the lungs in predicting the length of hospitalization, of intensive care and of mechanical ventilation in Covid-19 pneumonia. Further aims are the evaluation of the efficacy of the ultrasound of the lungs in predicting the risk of death and of long-term pulmonary complications as consequences of Covid-19 pneumonia.

Full description

Covid-19 pneumonia became the worldwide, serious health problem, affecting nearly 20 million people and causing nearly one million deaths. The health systems of many countries are overwhelmed with the increased need of medical care, of the number of available hospital beds, intensive care beds and ventilators. The proper management of available resources becomes now critical. Ultrasound can reliably detect morphologic changes associated with pneumonia, especially in Covid-19 pneumonia, where the involvement of superficial parts of the lungs predominates. Additionally, protocols were elaborated which unify the investigation procedure and improve the intra- and interrater reliability. Moreover, ultrasound is a time and cost-effective and widely available method. Finally, it is much easier to take measures, which minimize the risk of viral transmission between patients for ultrasound equipment than for other lung imaging devices such as x-ray or computer tomography. The aim of this study is to evaluate the efficacy of the ultrasound of the lungs in predicting the length of hospitalization, of intensive care and of mechanical ventilation in Covid-19 pneumonia. Further aims are the evaluation of the efficacy of the ultrasound of the lungs in predicting the risk of death and of the long-term pulmonary complications as consequences of Covid-19 pneumonia. The study will include repeated ultrasound investigations in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive patients admitted to the University Hospital in Cracow (Poland) performed during hospitalization and after discharge. The relation of severity and the course of pneumonia revealed by ultrasound to clinical condition, long term complications, use of mechanical ventilation, admission to intensive care and results of laboratory tests will be examined.

Enrollment: 94 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients sufficiently medically ill to require hospital admission.
• Confirmed SARS-CoV-2 infection by positive result on polymerase chain reaction testing of a nasopharyngeal sample not earlier than five days prior to inclusion.

Exclusion criteria

• Interstitial lung disease in the past.
• Chronic respiratory insufficiency.
• Significant bronchial obstruction n the day of admission to the University Hospital.
• Pulmonary embolism during three months before admission.
• Significant thorax deformity, which may disturb the investigation of the lungs with ultrasound.
• Hemodynamic instability
• Pregnancy (relative contraindication for computer tomography)

Trial design

94 participants in 2 patient groups

Changes in the lungs on admission

Description:

Patients with Covid-19 infection admitted to the University Hospital with changes in the ultrasound on admission, suggesting pneumonia.

No changes in the lungs on admission

Description:

Patients with Covid-19 infection admitted to the University Hospital without changes in the ultrasound on admission, suggesting pneumonia.