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Clinical Trials/NCT04513210
NCT04513210CompletedNot Applicable

Reliability of Standardized Protocol of Ultrasound of the Lungs in Prediction of Severity, Length of Hospitalization and Long-term Complications and of Covid-19 Infection

Jagiellonian University1 site in 1 country94 target enrollmentStarted: October 10, 2020Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
94
Locations
1
Primary Endpoint
Impact of ultrasonographic pneumonia signs on the day of admission on severity of COVID-19 infection

Study Overview

Brief Summary

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.

Detailed 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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Outcomes

Primary Outcomes

Impact of ultrasonographic pneumonia signs on the day of admission on severity of COVID-19 infection

Time Frame: Through study completion, an average of 1 year.

Comparison of frequency of intensive care, ventilator use and of the number of days of hospital stay, between group with signs of pneumonia vs. group without signs of pneumonia in the ultrasound, on the day of admission.

Relation of changes in ultrasound and progression to respiratory failure

Time Frame: Through study completion, an average of 1 year.

Comparison of percentage of patients with oxygenation index drop below 300 mmHg during 14 after inclusion between group with and without changes in the ultrasound on admission.

Secondary Outcomes

  • Sensitivity of ultrasonographic pneumonia signs in detecting respiratory failure(Through study completion, an average of 1 year.)
  • Sensitivity of ultrasound in detecting interstitial changes in the lungs(Through study completion, an average of 1 year.)
  • Impact change in severity of ultrasonographic pneumonia signs on severity of COVID-19 infection(Through study completion, an average of 1 year.)

Investigators

Sponsor
Jagiellonian University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jakub Antczak

Principal Investigator

Jagiellonian University

Study Sites (1)

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