Lung Ultrasound Score and Pediatric Intensive Care Outcomes (LUS-PICO) (LUS-PICO)

April 10, 2022 updated by: Fundación para la Investigación Biosanitaria del Principado de Asturias

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Lung aeration can be assessed at the bedside by means of lung ultrasound, a non-invasive, quick, simple, and reproducible technique. It provides semiquantitative information about the amount of extravascular lung water (EVLW), which correlates with lung aeration. Accumulation of EVLW occurs secondarily to acute lung injury due to infection, inflammation or fluid overload. Lung aeration, measured by the lung ultrasound score (LUS), has been associated to patients' outcome in several studies in adult patients, suggesting that critically ill subjects showing higher degree of aeration loss have a worse outcome. This fact has been shown not only in patients with baseline respiratory conditions (for example in severe acute respiratory syndrome coronavirus 2), but also in adults with non-respiratory conditions, such as shock and in high-risk postoperative patients. Furthermore, animal studies have suggested that information obtained through lung ultrasonography may precede clinical signs and could help anticipate focused treatment.

To date, pediatric studies addressing the potential relationship between LUS and the outcome of critically ill children are scarce and limited to postoperative cardiac patients and infants with bronchiolitis.

In our research, children from 1 month to 18 years of age admitted to pediatric intensive care unit (PICU) who fulfill inclusion criteria will be recruited and will undergo point of care lung ultrasound examination at 12 ± 6 hours and at 48-72 hours from admission. Clinical data will be recorded and LUS will be calculated. The main objective of our study is to assess the potential role of LUS (as a semiquantitative indicator or lung aeration) as a feasible and reliable outcome prediction tool in children admitted to PICU. Secondary objectives will include to analyze the correlations between LUS and the need and length of ventilatory support, inflammatory and cardiac markers, hydric balance, renal replacement therapies requirement, and validated prognostic scales, as well as age, underlying disease, co-morbidities, length-of-stay, and other clinical characteristics of included children.

Patients with acute respiratory distress syndrome (ARDS) or shock during PICU admission time will also undergo additional lung ultrasound examinations at 12 ± 6 hours and at 48-72 hours from ARDS or shock diagnosis, as these subgroups represent a very specific and severe cohort of patients, which merits further analysis.

Study Type

Observational

Enrollment (Actual)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Principado De Asturias
      • Oviedo, Principado De Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias (HUCA)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children 1 month to 18 years-old admitted to PICU due to an acute condition

Description

Inclusion Criteria:

  • Children 1 month to 18 years-old admitted to PICU due to an acute condition

Exclusion Criteria:

  1. - Children admitted to PICU to perform a procedure or to adjust a certain treatment (eg, home ventilatory support).
  2. - Children with chronic pulmonary pathology (cystic fibrosis, bronchopulmonary dysplasia, etc…)
  3. - Preoperative admissions in a stable condition (eg. Patient admitted previously to cardiac surgery)
  4. - Inability to obtain interpretable ultrasonographic images due to bad ultrasonographic window
  5. - Non disponibility of investigator
  6. - High frequency ventilation
  7. - Lack of clinical data

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Requirement of invasive mechanical ventilation for more than 96 hours
Time Frame: 96 hours
To evaluate the correlation of LUS obtained in the first 72 hours of admission with the need of invasive ventilatory support for over 96 hours. A comparison between patients with a respiratory condition versus non-respiratory condition as the cause of admission will be performed.
96 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between lung aeration and bedside inflammatory markers
Time Frame: 72 hours
To evaluate the relation between lung aeration estimated by LUS and bedside inflammatory markers (C reactive protein, interleukin-6, procalcitonin, ferritin)
72 hours
Correlation between lung aeration and bedside cardiac markers
Time Frame: 72 hours
To evaluate the relation between lung aeration estimated by LUS and bedside cardiac markers (Brain natriuretic peptide, N-terminal proBNP, troponin, cystatin C)
72 hours
Correlation between lung aeration and hydric balance and the need of renal replacement therapy
Time Frame: 72 hours
To evaluate the relation between lung aeration estimated by LUS and hydric balance and the need of renal replacement therapy
72 hours
Correlation between LUS and pediatric mortality scales
Time Frame: 72 hours
To evaluate the relation between lung aeration and three prognostic indexes: pediatric risk of mortality (PRISM) III, pediatric sequential organ failure assessment (pSOFA), pediatric logistic organ dysfunction 2 (PELOD-2). It will also be assessed whether LUS may add any prognostic capacity to these scales.
72 hours
Comparison of LUS calculation exploring 12 areas versus 8 areas
Time Frame: 72 hours
To compare the prognostic ability of LUS calculated employing 12 lung zones versus LUS obtained using 8 zones (anterior and lateral areas exclusively)
72 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of LUS in patients diagnosed with acute respiratory distress syndrome (ARDS) after 24 hours of admission
Time Frame: 72 hours
All previously specified objectives will be evaluated in children diagnosed with ARDS. In those cases, LUS will be calculated at 12 +/- 6 hours and 72 hours from ARDS diagnosis.
72 hours
Utility of LUS in patients diagnosed with shock after 24 hours of admission
Time Frame: 72 hours
All previously specified objectives will be evaluated in children diagnosed with shock after 24 hours from admission. In those cases, LUS will be calculated at 12 +/- 6 hours and 72 hours from shock diagnosis.
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación para la Investigación Biosanitaria del Principado de Asturias

Investigators

  • Study Chair: Guillermo M. Albaiceta, MD PhD, HUCA-FINBA. Universidad de Oviedo
  • Principal Investigator: Juan Mayordomo-Colunga, MD PhD, HUCA-FIBA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2020

Primary Completion (Actual)

March 31, 2021

Study Completion (Actual)

November 30, 2021

Study Registration Dates

First Submitted

December 3, 2020

First Submitted That Met QC Criteria

December 3, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 12, 2022

Last Update Submitted That Met QC Criteria

April 10, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FINBA_CritLab_3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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