Pediatric Lung UltrasoundEchoRéaPedNCT03939728
Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit
An observational study of Pediatric Lung Ultrasound and Pediatric Chest Radiography, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
In pediatric intensive care unit of Strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the "historic" and reference exam, and commonly systematically the lung ultrasound. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Pediatric Lung Ultrasound, Pediatric Chest Radiography, Pediatric Lung Diagnosis
- What is being tested?
- Chest radiography and lung ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jun 2019to 28 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient in pediatric intensive care unit, under 18 years old, which has, during his stay, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.
Who may be able to join
- Age under 18 years
- Patient in pediatric intensive care unit
- Patient registered with a social security scheme
- Agreement of the persons entitled to give parental authority over minor
- Patient which has, during his stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.
Who cannot join
- Refusal of the patient or of the persons entitled to give parental authority over minor to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
In pediatric intensive care unit of Strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the "historic" and reference exam, and commonly systematically the lung ultrasound.
However, chest radiography produces radiation and is less accessible in our unit, because it depends on the radiology department.
Read more
On the opposite, the lung ultrasound doesn't produce radiation, is simple, reliable, easily accessible (the investigators have two ultrasound systems in the unit), and simply and quickly achievable at the patient's bedside, including for less experienced operator.
We will evaluate the diagnostic performances of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit.
- Being tested
- Chest radiography and lung ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chest radiography and lung ultrasoundRadiation
We'll include all patients which have, during their stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.
| Study group | Role | What they receive |
|---|---|---|
| Chest radiography and lung ultrasound | All patients will be enrolled, during their stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval. Receives: Radiation: Chest radiography and lung ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kappa-measure
Kappa-measure of concordance between diagnosis obtained by lung ultrasound and chest radiography
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start3 Jun 2019
- Primary completion3 Jun 2019
- Study completion28 Jan 2021
Why it stopped: Investigators on maternity leave and COVID pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Lung UltrasoundStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939728
- Sponsor's protocol ID
- 7413
- Acronym
- EchoRéaPed
- Status last verified
- Dec 2022
- First submitted
- 3 May 2019
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03939728
- Acronym / sponsor ID
- EchoRéaPed / 7413
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Investigators on maternity leave and COVID pandemic
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 3 Jun 2019 (actual)
- Primary completion
- 3 Jun 2019 (actual)
- Study completion
- 28 Jan 2021 (actual)
- First posted
- 7 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In pediatric intensive care unit of Strasbourg, two exams are easily used for pleural and pulmonary diagnosis : chest radiography, which is the "historic" and reference exam, and commonly systematically the lung ultrasound.
However, chest radiography produces radiation and is less accessible in our unit, because it depends on the radiology department.
On the opposite, the lung ultrasound doesn't produce radiation, is simple, reliable, easily accessible (the investigators have two ultrasound systems in the unit), and simply and quickly achievable at the patient's bedside, including for less experienced operator.
We will evaluate the diagnostic performances of lung ultrasound and chest radiography for pleural and pulmonary diagnosis in pediatric intensive care unit.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chest radiography and lung ultrasound | – | Radiation: Chest radiography and lung ultrasoundAll patients will be enrolled, during their stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient in pediatric intensive care unit, under 18 years old, which has, during his stay, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.
Key inclusion criteria (5 listed)
- Age under 18 years
- Patient in pediatric intensive care unit
- Patient registered with a social security scheme
- Agreement of the persons entitled to give parental authority over minor
- Patient which has, during his stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.
Key exclusion criteria (1 listed)
- Refusal of the patient or of the persons entitled to give parental authority over minor to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chest radiography and lung ultrasoundWe'll include all patients which have, during their stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval. | Radiation | Chest radiography and lung ultrasound |
Primary outcome
Kappa-measure
Time frame: 12 months
Kappa-measure of concordance between diagnosis obtained by lung ultrasound and chest radiography
Results and safety
The study was stopped early (reason given: Investigators on maternity leave and COVID pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Pediatric Lung Ultrasound
Not yet recruitingObservational study
Ultrasound Findings in a Pediatric Population
Respiratory Tract Infections (RTI), Lung Ultrasound
Recruiting
Novel Tools to Improve Management of Paediatric Community-Acquired Pneumonia - ToolCAP
Pneumonia, Pneumonia Childhood
Not yet recruitingObservational study
Effect of Resuscitation on Gastric Emptying Using POCUS in Pediatric Trauma Patients
Hemorrhagic Shock, Pediatric Trauma
Not yet recruitingObservational study
Internal Jugular Vein Respiratory Variability as a Marker of Disease Severity in Infant Bronchiolitis
Acute Bronchiolitis, Viral Bronchiolitis
Recruiting
Effect of Pediatric Lung Ultrasound on Antibiotic Prescriptions in Hospitalized Children and Adolescents With Lower Respiratory Tract Infections. A Randomized Controlled Trial.
Lower Resp Tract Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Lung Ultrasound and Pediatric Chest Radiography, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigators on maternity leave and COVID pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kappa-measure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2022.