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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03939728
Other study ID # 7413
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date June 3, 2019
Est. completion date January 28, 2021

Study information

Verified date December 2022
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Terminated
Enrollment 150
Est. completion date January 28, 2021
Est. primary completion date June 3, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion criteria: - 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. Exclusion criteria: - Refusal of the patient or of the persons entitled to give parental authority over minor to participate in the study

Study Design


Intervention

Radiation:
Chest radiography and lung ultrasound
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.

Locations

Country Name City State
France Les Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Kappa-measure Kappa-measure of concordance between diagnosis obtained by lung ultrasound and chest radiography 12 months