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

NCT04660448 | Completed

• 1 other identifier: FINBA_CritLab_3
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Injury; Extravascular Lung Water; Pulmonary Edema; Acute Respiratory Distress Syndrome; Shock

Outcome Measures

Primary Outcomes (1)

• Requirement of invasive mechanical ventilation for more than 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 Outcomes (5)

• Correlation between lung aeration and bedside inflammatory markers

  72 hours

• Correlation between lung aeration and bedside cardiac markers

  72 hours

• Correlation between lung aeration and hydric balance and the need of renal replacement therapy

  72 hours

• Correlation between LUS and pediatric mortality scales

  72 hours

• Comparison of LUS calculation exploring 12 areas versus 8 areas

  72 hours

Other Outcomes (2)

• Utility of LUS in patients diagnosed with acute respiratory distress syndrome (ARDS) after 24 hours of admission

  72 hours

• Utility of LUS in patients diagnosed with shock after 24 hours of admission

  72 hours

Interventions

Bedside lung ultrasound examination DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fundación para la Investigación Biosanitaria del Principado de Asturias: lead

Study Sites (1)

Hospital Universitario Central de Asturias (HUCA)

Oviedo, Principality of Asturias, 33011, Spain

Location

Related Publications (32)

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MeSH Terms

Conditions

Lung Injury; Pulmonary Edema; Respiratory Distress Syndrome; Shock

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillermo M. Albaiceta, MD PhD

  HUCA-FINBA. Universidad de Oviedo

  STUDY CHAIR

• Juan Mayordomo-Colunga, MD PhD

  HUCA-FIBA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: December 1, 2020
• Primary Completion: March 31, 2021
• Study Completion: November 30, 2021
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

ES (1)