The Role of Chest Ultrasound in Patients With Respiratory Tract Infections

NCT06694285 | Not Yet Recruiting

• 1 other identifier: 6520
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• The ultrasound pattern of patients with respiratory tract infections

  To evaluate the ultrasound pattern of patients with respiratory tract infections by score.

  1 hour

Secondary Outcomes (6)

• the duration of hospitalization

  1 hour

• Use the SatO2/FiO2 ratio to evaluate outcome

  20 minutes

• correlation between ultrasound score and vital parameters

  1 hour

• correlation between ultrasound score and indices of inflammation

  1 hour

• correlation between ultrasound parameters and etiology

  2 days

Interventions

Ultrasound evaluation DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS UOSD Pronto Soccorso Pediatrico

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Antonio Gatto

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Gatto

CONTACT

+390630155940; antonio.gatto@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: September 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: September 2, 2025

Record last verified: 2024-11

Locations

IT (1)