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

Acute Respiratory Distress Syndrome Clinical Trial

— LUS-PICO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04660448
• Other study ID #: FINBA_CritLab_3
• Status: Completed
• Start date: December 1, 2020
• Est. completion date: November 30, 2021

Study information

• Verified date: April 2022
• Source: Fundación para la Investigación Biosanitaria del Principado de Asturias
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 650
• Est. completion date: November 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Extravascular Lung Water
• Lung Injury
• Pulmonary Edema
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Shock

Intervention

Diagnostic Test:
• Bedside lung ultrasound examination
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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias (HUCA)	Oviedo	Principado De Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Fundación para la Investigación Biosanitaria del Principado de Asturias

Country where clinical trial is conducted

Spain, 

References & Publications (32)

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* Note: There are 32 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Utility of LUS in patients diagnosed with acute respiratory distress syndrome (ARDS) after 24 hours of admission	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
Other	Utility of LUS in patients diagnosed with shock after 24 hours of admission	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
Primary	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	Correlation between lung aeration and bedside inflammatory markers	To evaluate the relation between lung aeration estimated by LUS and bedside inflammatory markers (C reactive protein, interleukin-6, procalcitonin, ferritin)	72 hours
Secondary	Correlation between lung aeration and bedside cardiac markers	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
Secondary	Correlation between lung aeration and hydric balance and the need of renal replacement therapy	To evaluate the relation between lung aeration estimated by LUS and hydric balance and the need of renal replacement therapy	72 hours
Secondary	Correlation between LUS and pediatric mortality scales	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
Secondary	Comparison of LUS calculation exploring 12 areas versus 8 areas	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