An observational study in Respiratory Tract Infections (RTI) and Lung Ultrasound, sponsored by Odense University Hospital. Not yet recruiting at 1 site in Denmark. Open to participants aged 28 Days to 18 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Odense University Hospital · Observational
The purpose of this study is to investigate whether focused ultrasound of the chest can be used in a practical way in children with respiratory symptoms. The investigators will examine the different ways in which the ultrasound examination can be performed and what the examination may show in children with different types of respiratory symptoms.
The investigators will also investigate how this type of ultrasound examination can be introduced and used in everyday practice in a paediatric department. The results will help understand how chest ultrasound can best be used in children and which examination method is most suitable for future use.
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.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's planned enrollment of 138 is below the median of 350 across 184 observational studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →Odense University Hospital is the lead sponsor of 479 studies on the registry; 110 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This study is conducted in the Pediatric Emergency Department at Odense University Hospital. The population is a non-selected cohort of children in all ages, presenting with respiratory symptoms to a pediatric emergency department. Patients will be included as a convenience sample during the period from October 19, 2026, to May 1, 2027.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Children ages 0-18 admittet to the pediatric emergency department at Odense university hospital, Denmark, who meets the inclusion criteria. Patients will be examined by the responsible treating physician, who will conduct diagnostic evaluation and treatment according to clinical standards as it is not uncommon for an initial FTUS to have already been performed. If an FTUS is performed by the treating physician, the examined zones, acquired images, and clinical interpretations will be documented. The data collectors will observe the procedure and perform a supplementary scan within the first four hours of admission to ensure that all areas are covered, using a standardized 14-zone scanning protocol and appropriate transducers.
Focused Thoracic ultrasound findings in a children admitted to a pediatric emergency department, divided into type
Type of ultrasound findings relevant: Lungsliding present? yes/no Lungpulse present? yes/no B-lines present? yes/no Consolidation present? yes/no Subpleural consolidation present? yes/no Pleural effusion present? yes/no Pleural thickness og irregulations? yes/no
Time frame: FTUS should be performed within the first 4-hours of admission to the pediatric emergency department
Characterization of findings on Focused Thoracic ultrasound, in a children admitted to a pediatric emergency department
Characterization: Number of B-lines in zones with B-lines present Size of consolidations in mm Size of subpleural consolidations in mm Pleural effusion - simple or complex Thickness of pleura if thickened
Time frame: FTUS should be performed within the first 4-hours of admission to the pediatric emergency department
Proportion of children who undergo examination of all 14-zones
Number of children who undergo examination of 14-zones
Time frame: FTUS should be performed within the first 4-hours of admission to the pediatric emergency department, and data regarding number of examined zones will be noted in RedCap database within the following hour of FTUS examination
Time to complete examination
How many minutes it takes to complete the examination
Time frame: FTUS should be performed within the first 4-hours of admission to the pediatric emergency department, and data regarding the time spend on the examination will be noted within the first hour following the FTUS examination
Type of transducer used for examination
Number of zones scanned using a linear transducer, and number of zones scanned using convex transducer
Time frame: FTUS should be performed within the first 4-hours of admission to the pediatric emergency department, and data regarding the type of transducer and preset used, will be noted in our RedCap datase within the following hour of FTUS examination
Type of transducer-preset used for examination
Number of zones scanned using a lung-preset, and number of zones scanned using abdominal-preset
Time frame: FTUS should be performed within the first 4-hours of admission to the pediatric emergency department, and data regarding the type of transducer and preset used, will be noted in our RedCap datase within the following hour of FTUS examination
Quality of images on a Likert-scale of 1-3 and interrater reliability
1. Not usefull: Images of insufficient quality for diagnostic purposes; key structures not identifiable. 2. Useful but not optimal for diagnostic imaging: Images of adequate quality to support interpretation, but with limitations such as suboptimal gain, depth, or partial obscuration. 3. Useful and optimal for diagnostic imaging: High-quality images with clear anatomical landmarks and artifact patterns sufficient for confident interpretation
Time frame: Children admitted to a pediatric emergency department between 1 of October 2026 and 1 of May 2027
The childs position during the scan
Is the child sitting og lying during the scan
Time frame: FTUS should be performed within the first 4-hours of admission to the pediatric emergency department, and data regarding the position of the child, will be noted in our RedCap datase within the following hour of FTUS examination
Association between focused thoracic ultrasound findings and final diagnosis
The association between focused thoracic ultrasound findings and the final clinical diagnosis established during the hospital admission.This includes assessing whether specific ultrasound findings or combinations of findings are associated with particular diagnoses
Time frame: 5-7 days after the child has been discharged, the final diagnosis will be extracted from their medical journal and put into our RedCap database. This allows sufficient time for the results of microbiological testing to be completed and registered
Start is estimated for Oct 2026; primary completion for May 2027, 6 months later.
Of 66 non-industry observational studies under Respiratory Tract Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 6 months is below that.
Counting every sponsor, half of 85 studies reached it within 18 months; a quarter within 8 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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