ProtocolInternational Journal of Clinical Trials

Publication:
Diagnostic accuracy of pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized: a prospective diagnostic cohort study

Int J Clin Trials. 2024;11(2):140-144.DOI10.18203/2349-3259.ijct20240965

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Abstract

Background Pneumonia, the leading infectious cause of death in children worldwide, often requires a chest radiograph (CXR) for diagnosis, involving radiation exposure. Point-of-Care Ultrasound (POCUS) offers a radiation-free alternative and, specifically the pocket-size variant, enhances convenience at the patient's bedside. While evidence supports ultrasound's accuracy in detecting community-acquired pneumonia (CAP) in children comparable to CXR, few studies have explored its ability to distinguish pneumonia etiology, especially utilizing pocket-size POCUS devices.

Methods In this prospective diagnostic cohort study conducted over a year in a tertiary pediatric referral center, we aim to assess the diagnostic accuracy of a pocket-size POCUS device compared to CXR for determining the etiology of CAP in pediatric patients (aged >6 months and <18 years). At least 76 participants diagnosed with CAP will undergo independent POCUS examinations at various intervals, complemented by CXRs when necessary, independently classified by a third investigator. The General Electrics Vscan AirTM®, featuring Bluetooth connectivity to smartphone/tablet, will be employed for POCUS. Data collection will include systematized POCUS and CXR descriptions, alongside sociodemographic, clinical, and therapeutic variables. Statistical analysis using SPSS® version 28 will evaluate the diagnostic accuracy of the POCUS device.

Conclusions This trial's outcomes hold significant promise in unveiling unknown data about the diagnostic accuracy of pocket-size POCUS for pediatric CAP etiological diagnosis. Utilizing a device meeting technical recommendations, featuring a dual-headed probe and Bluetooth connectivity, this study has the potential to bring innovation to clinical practice, improving patient care and creating scientific value. Trial Registration Number: NCT06296693.

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Affiliations

  1. Pediatric Department, Centro Materno Infantil do Norte, Centro Hospitalar Universitário de Santo António, Porto, Portugal
  2. Radiology Department, Centro Hospitalar Universitário de Santo António, Porto, Portugal
  3. Pediatric Pulmonology Unit, Pediatric Department, Centro Materno Infantil do Norte, Centro Hospitalar Universitário de Santo António, Porto, Portugal
  4. Pediatric Pulmonology Unit, Pediatric Department, Centro Materno Infantil do Norte, Centro Hospitalar Universitário de Santo António, Porto, Portugal; ICBAS, School of Medicine and Biomedical Sciences, Porto, Portugal
  5. Pediatric Pulmonology Unit, Pediatric Department, Centro Materno Infantil do Norte, Centro Hospitalar Universitário de Santo António, Porto, Portugal; ICBAS, School of Medicine and Biomedical Sciences, Porto, Portugal; CINTESIS@RISE, MEDCIDS, Faculty of Medicine of the University of Porto, Porto, Portugal

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