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Not yet recruiting NCT06694285

The Role of Chest Ultrasound in Patients With Respiratory Tract Infections

Observational Respiratory Tract Infections

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound evaluation.
Who it may be relevant to
Registry conditions: Respiratory Tract Infections. Basic parameters: up to 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Observational Study on the Role of Chest Ultrasound in Patients With Respiratory Tract Infections

Overview

Respiratory tract infections are a major cause of hospitalization among pediatric and adult patients, regardless of the cause, whether viral or bacterial. It is critical to stratify each patient's risk to predict the subsequent clinical course. Point-of-care chest ultrasonography in parallel with clinical evaluation has been found to be an effective tool to assess the severity of pathology. A number of scores have been validated on the basis of the ultrasound picture. Currently, a growing interest is directed toward the unambiguous validation of an ultrasound score that can predict the patient's outcome in terms of hospitalization, ICU admission, need for a more pronounced approach in terms of respiratory care both qualitatively and quantitatively.

Detailed description

Acute respiratory infections are the leading cause of illness and mortality in children under five, with children experiencing three to six episodes annually. This prevalence remains consistent across various demographics, although the severity of these infections differs significantly between high- and low-income countries. In developing nations, factors such as specific pathogens and risk factors contribute to higher mortality rates from these diseases. The most common respiratory infections in young children include pneumonia and bronchiolitis. Bronchiolitis, primarily caused by respiratory syncytial virus (RSV), is a significant viral infection affecting infants, particularly those under one year old, with peak incidence between three to six months. RSV affects 50-80% of bronchiolitis cases, while other viruses like rhinoviruses and influenza may also play roles. The American Academy of Pediatrics recommends a clinical diagnosis for bronchiolitis, reserving chest radiography for severe cases to exclude other conditions. Treatment is largely supportive, focusing on hydration and respiratory care, with only about 6% of cases requiring intensive care unit admission. Bacterial pneumonia is another major respiratory infection in children, often caused by Streptococcus pneumoniae or Haemophilus influenzae type b (Hib). Atypical pneumonias can arise from Mycoplasma pneumoniae and Chlamydia pneumoniae, particularly in older children. Current guidelines suggest that patients with uncomplicated community-acquired pneumonia do not require chest imaging or laboratory tests and can often be treated at home. Effective clinical assessment is crucial for stratifying risk in respiratory infections. Vital signs such as heart rate and respiratory rate, along with physical examination findings like wheezing or use of accessory muscles, help predict clinical outcomes. However, these assessments can be complicated by factors like fever or patient compliance issues. Recent studies have highlighted the utility of lung ultrasonography as a point-of-care tool for assessing various pulmonary conditions in pediatrics, correlating ultrasound patterns with disease severity. In pediatric acute respiratory distress syndrome (PARDS), a new definition has emerged that shifts focus from bilateral infiltrates to the saturation-to-inhaled oxygen fraction (S/F) ratio for assessing severity. An S/F ratio below 235 indicates moderate PARDS, while below 212 signifies severe PARDS. This approach enhances the evaluation of respiratory distress in children, providing a more practical method for predicting clinical outcomes based on easily obtainable parameters.

Interventions

  • Diagnostic test Ultrasound evaluation
    The subjects will constitute a cohort whose medical history, clinical, ultrasound and treatment data reported in the appropriate data collection form will be prospectively collected. Enrolled patients will undergo clinical and ultrasonographic evaluation in a manner not unlike routine clinical practice.

Primary outcome measures

  • The ultrasound pattern of patients with respiratory tract infections [Time frame: 1 hour]
Secondary outcome measures (6)
  • the duration of hospitalization [Time frame: 1 hour]
  • Use the SatO2/FiO2 ratio to evaluate outcome [Time frame: 20 minutes]
  • correlation between ultrasound score and vital parameters [Time frame: 1 hour]
  • correlation between ultrasound score and indices of inflammation [Time frame: 1 hour]
  • correlation between ultrasound parameters and etiology [Time frame: 2 days]
  • possible correlations between various epidemiologic and clinical data [Time frame: 2 hours]

Eligibility criteria

Inclusion criteria

  • Patients aged 0 to 20 years with a clinical diagnosis of respiratory tract infection, evaluated in the emergency department and then discharged home or admitted to the Pediatric Intensive Care Unit or Pediatrics Department.
  • Informed consent signed by parents or patient of legal age

Exclusion criteria

  • Refusal to sign informed consent
  • Patients with bronchopulmonary dysplasia
  • Foreign body aspiration cases
  • Patients with pulmonary malformations
  • Patients with neuromuscular diseases
  • Patients with hemodynamically significant congenital heart disease

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario A. Gemelli IRCCS UOSD Pronto Soccorso Pediatrico — Rome

Identifiers

NCT: NCT06694285 · 6520

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗