EchoRéaPed: Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit

• Sponsor: University Hospital, Strasbourg, France (Other)
• Overall Status: Completed
• CT.gov ID: NCT03939728
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Actual Duration (Months): 12
• Patients Per Site Per Month: 12.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Lung Ultrasound; Pediatric Chest Radiography; Pediatric Lung Diagnosis	Radiation: Chest radiography and lung ultrasound

Study Design

• Study Type: Observational
• Actual Enrollment: 150 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Comparison of Lung Ultrasound and Chest Radiography for Pleural and Pulmonary Diagnosis in Pediatric Intensive Care Unit
• Actual Study Start Date: Jul 9, 2019
• Actual Primary Completion Date: Jul 9, 2020
• Actual Study Completion Date: Jul 9, 2020

Arms and Interventions

Arm	Intervention/Treatment
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.	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.

Outcome Measures

Primary Outcome Measures

1. Kappa-measure [12 months]

   Kappa-measure of concordance between diagnosis obtained by lung ultrasound and chest radiography

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Les Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67098

Sponsors and Collaborators

• University Hospital, Strasbourg, France

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Strasbourg, France
• ClinicalTrials.gov Identifier: NCT03939728
• Other Study ID Numbers: 7413
• First Posted: May 7, 2019
• Last Update Posted: Mar 25, 2021
• Last Verified: May 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Disease

Study Results

No Results Posted as of Mar 25, 2021