CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 650 enrolled
Drug / intervention
Bedside lung ultrasound examinationother
Likely dose
Not stated in record
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Search/NCT04660448
NCT04660448N/ACompleted

Lung Ultrasound Score and Pediatric Intensive Care Outcomes: a Prospective Observational Multicenter Study

Fundación para la Investigación Biosanitaria del Principado de Asturias·observational·Posted Dec 9, 2020·Updated Apr 12, 2022

In Brief

An observational study evaluating Bedside lung ultrasound examination for Lung Injury and 4 related conditions. Completed, enrolled 650 participants across 1 site.

Detailed Summary

Bedside lung ultrasonography helps to obtain reliable clinical information about lung aeration, that has been categorized by means of the so-called lung ultrasound score (LUS). In critically ill adults, LUS has been related with the outcome both in patients with respiratory and some non-respiratory conditions. Pediatric studies about lung aeration have been done mainly on postoperative cardiac patients and infants with bronchiolitis. In this prospective, observational, multicenter, feasibility and diagnostic accuracy study, we will explore the degree of lung aeration impairment as a potential outcome predictor in critically ill children with a variety of underlying conditions. Children from 1 month to 18 years of age admitted to PICU will be recruited and LUS will be calculated at two time points: at 12 ± 6 hours and at 48-72 hours. Univariate and multivariate statistical analysis will be performed in order to ascertain the outcome influence of clinical factors in general and LUS in particular.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesSpain
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedDec 9, 2020
Enrollment StartDec 1, 2020
Primary CompletionMar 31, 2021
Study CompletionNov 30, 2021
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 5.6 years ago

Interventions

Bedside lung ultrasound examinationother

Lung ultrasound exploring 12 areas (6 in each lung) at 12 +/- 6 hours and at 48-72 hours from PICU admission. Clinical and analytical data collection coinciding with ultrasound imaging and during follow-up while admitted to PICU.