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

NCT03939728 | Terminated

• 1 other identifier: 7413
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Lung Ultrasound; Pediatric Chest Radiography; Pediatric Lung Diagnosis

Outcome Measures

Primary Outcomes (1)

• Kappa-measure

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

  12 months

Study Arms (1)

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

Interventions

Chest radiography and lung ultrasound RADIATION

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.

Chest radiography and lung ultrasound

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• \- Refusal of the patient or of the persons entitled to give parental authority over minor to participate in the study

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2019
• First Posted: May 7, 2019
• Study Start: June 3, 2019
• Primary Completion: June 3, 2019
• Study Completion: January 28, 2021
• Last Updated: December 13, 2022

Record last verified: 2022-12

Locations

FR (1)