Pneumonia Clinical Trial
Official title:
A Prospective International Lung UltraSound Analysis (ILUSA) Study in Tertiary Maternity Wards During the SARS-CoV-2 Pandemic
Currently there is a great need for an accurately and rapid assessment of patients suspected
for Covid-19. Like CT, Lung Ultrasound (LUS) examination can potentially help with the
initial triage of patients but also help track the evolution of the disease. LUS can be used
in every setting, including settings with limited infrastructure, allowing the reduction of
disparities in trials participation. LUS is also a practical approach that can be used by
obstetricians/gynecologists, who are the primary care givers in the labour and delivery room.
The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter
prospective explorative observational study to assess the predictive value of LUS in Covid-19
suspected and diagnosed pregnant patients.
During the current COVID-19 outbreak, all patient groups have been affected, also the most
fragile such as the pregnant women. Although experts provided general suggestions on the best
management of pregnant women with suspected or confirmed COVID-19, these considerations are
mainly based on retrospective studies or case series. No prospective study is currently
available about management of confirmed or suspected patients during pregnancy. Moreover,
only limited outcome data is available on the management of asymptomatic SARS-CoV-2 positive
pregnant patients, many of whom subsequently develop disease symptoms.
The current gold standard for the etiological diagnosis of COVID-19 infection is analysis of
respiratory tract specimens by (real-time) reverse transcription polymerase chain reaction
(RT-PCR). However, this test has a high false-negative rate, due to both nasopharyngeal swab
sampling error, which often requires repeat sampling, and changing viral burden. Currently,
high-resolution computed tomography (CT) is the main tool for primary diagnosis and
evaluation of disease severity in patients affected by COVID-19 infection. Chest CT scan also
demonstrated a specificity even superior to the nasal/pharyngeal swab for diagnosis. Yet,
radiation exposure should ideally be avoided at all times in pregnancy. A radiation-free
point-of-care diagnostic tool, such as lung ultrasound (LUS) examination, would be
particularly useful for assessing the lungs of pregnant women. Indeed, LUS examination has
recently been suggested by the Chinese Critical Care Ultrasound Study Group and the Italian
Academy of Thoracic Ultrasound as an accurate tool to detect lung involvement during
COVID-19.
In pregnant patients, LUS could be a valid alternative imaging tool to thoracic CT to
guarantee appropriate care for these patients. Symptomatic patients with a low risk of
developing serious disease may be possibly reassured, and could leave the hospital soon after
delivery. On the other hand LUS could possibly indicate patients at higher risk for future
need of oxygen or ventilation support, and who might need more careful monitoring and longer
hospitalization. In view of the wide availability in delivery suites, the low cost and easy
bedside application LUS could also be readily repeated during patient follow up as needed.
LUS has been traditionally employed by non-radiologists as an adjunctive clinical instrument.
Obstetricians represent a category of clinicians who use ultrasound in their daily routine
practice. From a technical point of view, examination of the lungs at the time of obstetric
ultrasound evaluation could be feasible for obstetricians and gynaecologists.
Currently there is a great need for an accurately and rapid assessment of patients suspected
for Covid-19. Like CT, LUS can potentially help with the initial triage of patients but also
help track the evolution of the disease. LUS can be used in every setting, including settings
with limited infrastructure, allowing the reduction of disparities in trials participation.
LUS is also a practical approach that can be used by obstetricians/gynecologists, who are the
primary care givers in the labour and delivery room.
The International Lung UltraSound Analysis (ILUSA) Study is an international multicenter
prospective explorative observational study to assess the predictive value of LUS in Covid-19
suspected and diagnosed pregnant patients.
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