Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children

NCT06296693 | Not Yet Recruiting

• 1 other identifier: 2023.062(051-DEFI/053-CE)
• Study Type: interventional
• Target: 76
• Locations: 0 countries
• Sites: N/A

Brief Summary

1. 1.Background and study aims Pneumonia is the leading infectious cause of death in children worldwide. Although the diagnosis is clinical, a chest radiograph (CXR) is often necessary to clarify it, exposing the patient to radiation. Ultrasound has been increasingly used in the evaluation of the lung parenchyma without exposing patients to radiation. The pocket-size Point-of-Care Ultrasound (POCUS) can be used at the patient's bedside proving comfort and saving time. Evidence suggests that ultrasound can detect CAP (community-acquired pneumonia) in children with similar accuracy and reliability as CXR. However, few studies evaluated the ability to distinguish the aetiology of pneumonia and none used a pocket-size POCUS device. This study aims to assess, for the first time, the diagnostic accuracy of a pocket-size POCUS device for the etiological diagnosis of CAP vs. CXR, in paediatric ages. Secondarily, the investigators intend to evaluate the correlation between CXR image vs. ultrasound, the correlation between clinical progression and ultrasound images, and the diagnostic accuracy to detect complications.
2. 2.Who can participate:
3. 3.What does the study involve:
4. 4.What are the possible benefits and risks of participating:
5. 5.Where is the study run from:
6. 6.When is the study starting and how long is it expected to run for:

Conditions

Pneumonia; Pneumonia, Viral; Pneumonia, Bacterial

Keywords

bacterial pneumonia; community-acquired pneumonia; chest radiograph; digital health; POCUS; viral pneumonia

Outcome Measures

Primary Outcomes (1)

• POCUS vs. CXR for the etiological diagnosis of CAP

  Diagnostic accuracy of a pocket-size POCUS device for the etiological diagnosis of CAP vs. CXR, in paediatric ages. It will be classified as bacterial CAP in POCUS the association of lung consolidations, air bronchogram and shred sign. Viral CAP in POCUS will be considered in the presence of at least one: pleural abnormalities (irregularity or thickening), variable number (at least three) and coalescence of B-lines, multiple small subpleural consolidations. It will be classified as bacterial CAP in CXR when lung consolidations are present, represented as hypotransparencies areas that tends to occur initially in the peripheral subpleural lung and spreads centrally. Viral CAP in CXR will be considered in the presence of bilateral patchy hypotransparencies and diffuse areas of air space consolidation or interstitial lung disease.

  From enrollment to the end of follow-up at 1 month

Secondary Outcomes (3)

• CXR image vs. ultrasound

  From enrollment to the end of follow-up at 1 month

• Clinical progression and ultrasound images

  From enrollment to the end of follow-up at 1 month

• Complications

  From enrollment to the end of follow-up at 1 month

Study Arms (1)

POCUS-L

EXPERIMENTAL

The investigators will study the diagnostic accuracy of a pocket-size POCUS device vs. CXR for the etiological diagnosis of CAP, in paediatric age. During 1 year, all children aged \>12 months and \<18 years admitted to the Paediatric Department with the diagnosis of CAP on admission will be included. At least 76 participants will be required. Two investigators will perform, independently, a POCUS at admission, daily during hospitalization, 15 days and 1 month after discharge. All children will also undergo a CXR upon admission and whenever necessary. A third investigator will classify the CXR independently. It will be used the General Electrics Vscan AirTM®, with Bluetooth connection to smartphone/tablet. It will be collected the systematized description of POCUS and CXR, sociodemographic, clinical and therapeutic variables.

Device: Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized

Interventions

Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized DEVICE

The investigators will study the diagnostic accuracy of a pocket-size POCUS device vs. CXR for the etiological diagnosis of CAP, in paediatric age. During 1 year, all children aged \>12 months and \<18 years admitted to the Paediatric Department with the diagnosis of CAP on admission will be included. At least 76 participants will be required. Two investigators will perform, independently, a POCUS at admission, daily during hospitalization, 15 days and 1 month after discharge. All children will also undergo a CXR upon admission and whenever necessary. A third investigator will classify the CXR independently. It will be used the General Electrics Vscan AirTM®, with Bluetooth connection to smartphone/tablet. It will be collected the systematized description of POCUS and CXR, sociodemographic, clinical and therapeutic variables.

POCUS-L

Eligibility Criteria

• Age: 12 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age \>12 months and \<18 years
• Hospitalization in the Paediatric Department
• CAP diagnosis on admission (based on the physician's clinical judgment, namely through clinical, analytical and/or CXR criteria)

You may not qualify if:

• Nosocomial pneumonia
• Cystic fibrosis diagnosis
• Long-term use of domiciliary ventilation.

Sponsors & Collaborators

• Centro Hospitalar Universitário de Santo António: lead

MeSH Terms

Conditions

Pneumonia; Pneumonia, Viral; Pneumonia, Bacterial; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases; Virus Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Community-Acquired Infections

Study Officials

• Sara Monteiro

  Centro Hospitalar Universitário de Santo António

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Monteiro

CONTACT

+351 914272547; saraapmonteiro@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 29, 2023
• First Posted: March 6, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2025
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share