Ultrasound Findings in a Pediatric Population

Aim and collaborations The aim of this study is to examine and characterize the type of focused thoracic ultrasound (FTUS) findings in a non-selected cohort of children with respiratory symptoms, categorized by type (e.g., B-lines, consolidation, effusion). Additionally, the study aims to evaluate the feasibility of implementing FTUS in a pediatric department and future considerations regarding choice of protocol in a pediatric population.

The project will be conducted as a collaboration between the Department of Pediatrics, the Department of Respiratory Medicine, and the Department of Radiology at Odense University Hospital. The principal investigators are SB, EC, and PB.

Method, study design and data collection This study is designed as a prospective observational feasibility study conducted in the Pediatric Emergency Department at Odense University Hospital. The study population is an non-selected cohort of children between the ages of 28 days-18 age, who presents with respiratory symptoms or clinical signs of respiratory infections.

Screening of eligibility will be performed using data available from Cetrea (a patient flow management system), through which patients are admitted to the department and prioritized according to clinical symptoms and vital parameters. Inclusion will occur following written and oral information provided to the patient and/or parents/legal guardians, and after obtaining informed consent from either the patient, if they are over the age of 15, or by parents/ legal guardians. Patients will be examined by the responsible treating physician, who will conduct diagnostic evaluation and treatment according to clinical standards.

A FTUS examination using a 14-zones scanning protocol will subsequently be performed within the first four hours of admission. The ultrasound examinations will be performed by two medical students who have completed the regional course, followed by supervised training and certification. Ultrasound findings, use of transducer, transducer preset, and positions of the child will be examined, and data will be recorded. Furthermore symptoms, diagnostic procedures, therapeutic interventions, and discharge diagnoses will also be recorded. The feasibility of the protocol choice will be evaluated during data collection. Data management will be conducted primarily using Redcap for data entry and SharePoint/OPEN storage for secure data storage. Data will be securely stored in Redcap. No biological samples will be collected.

In the case of incidental or unexpected findings, the project investigators (EC, AH, or PGB) will be contacted to determine the need for further evaluation. In cases of suspected acute conditions, a pediatric physician will be contacted, and appropriate urgent measures will be initiated if necessary.

Statistical analysis Descriptive statistical analyses will be performed. The sample size is based on an expected prevalence of positive LUS findings of 10%. As this is a feasibility study, the primary aim is to assess applicability of LUS in a pediatric population, and the investigators will therefore include as many participants as possible. The final sample size may be adjusted based on practical considerations if deemed appropriate. Final sample size = 139 children

Adverse Effects, Risks, and Ethical Considerations Participation is voluntary and based on informed consent. Lung ultrasound is a safe and painless modality with no known adverse effects. It allows the child to sit on the lap of their parent, which can provide a feeling of safety and thus make the examination easier and more effective. Participants may experience minor transient discomfort due to light pressure from the ultrasound probe and cooling from the ultrasound gel. There are no known physical or psychological risks associated with participation. If unexpected suspicious findings are detected during the examination, participants will be contacted regarding the need for further evaluation.

Lung ultrasound will be used as a supplement to clinical evaluation. Ultrasound findings will be recorded, and it will be noted whether the treating physician considers that these findings would have resulted in a change in diagnostic or therapeutic management XXXXXXXXXXXXXX

Future perspectives and clinical impact The study aims to contribute to the evidence-based use of ultrasound in the diagnostic evaluation of children with respiratory symptoms. These data may help predict the association between clinical findings, diagnosis, and patient prognosis, in order to optimize diagnostic accuracy and minimize unnecessary radiation exposure.