Ignite Creation Date:
2024-05-06 @ 8:12 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06296693
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-06
First Post:
2023-12-29
Brief Title:
Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children
Sponsor:
Centro Hospitalar Universitário de Santo António
Organization:
Centro Hospitalar Universitário de Santo António
Study Overview
Official Title:
Diagnostic Accuracy of Pocket-size Lung Ultrasound for Etiological Definition of Pneumonia and Surveillance of Complications in Children Hospitalized a Prospective Diagnostic Cohort Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POCUS-L
Brief Summary:
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 patients 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 Who can participate
The investigators will include consecutively all children aged 12 months and 18 years hospitalized to the Paediatric Department with the diagnosis of CAP on admission The investigators will exclude children hospitalized with nosocomial pneumonia with cystic fibrosis diagnosis or on long-term domiciliary ventilation
3 What does the study involve
The diagnostic accuracy between POCUS and CXR in differentiating the type of pneumonia will be assessed All participants will perform 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
4 What are the possible benefits and risks of participating
Children will have a more frequent and serial assessment of CAP which does not involve risks
5 Where is the study run from
The study if from Centro Materno Infantil do Norte - Centro Hospitalar Universitário de Santo António a tertiary paediatric referral centre
6 When is the study starting and how long is it expected to run for
The recruitment period is expected to start in January2024 and end in January 2025
2 Who can participate
The investigators will include consecutively all children aged 12 months and 18 years hospitalized to the Paediatric Department with the diagnosis of CAP on admission The investigators will exclude children hospitalized with nosocomial pneumonia with cystic fibrosis diagnosis or on long-term domiciliary ventilation
3 What does the study involve
The diagnostic accuracy between POCUS and CXR in differentiating the type of pneumonia will be assessed All participants will perform 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
4 What are the possible benefits and risks of participating
Children will have a more frequent and serial assessment of CAP which does not involve risks
5 Where is the study run from
The study if from Centro Materno Infantil do Norte - Centro Hospitalar Universitário de Santo António a tertiary paediatric referral centre
6 When is the study starting and how long is it expected to run for
The recruitment period is expected to start in January2024 and end in January 2025
Detailed Description:
The investigators will perform a prospective diagnostic cohort study in a tertiary paediatric referral centre to study the diagnostic accuracy of a pocket-size Point-of-Care Ultrasound POCUS device vs chest radiograph 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 smartphonetablet It will be collected the systematized description of POCUS and CXR sociodemographic clinical and therapeutic variables Statistical analysis will be performed using SPSS version 28
This study won a competitive grant from MSD Portugal The amount will be applied exclusively in the systematization and standardization of the POCUS technique with the guidance of an external consultant in the statistical analysis in the dissemination of results through participation in a national and international congress and in the creation of a task-force for the national implementation of this technique in paediatric services The design implementation analysis and dissemination of this stury will be independent from MSD Portugal and from the entire responsibility of the authors
This study won a competitive grant from MSD Portugal The amount will be applied exclusively in the systematization and standardization of the POCUS technique with the guidance of an external consultant in the statistical analysis in the dissemination of results through participation in a national and international congress and in the creation of a task-force for the national implementation of this technique in paediatric services The design implementation analysis and dissemination of this stury will be independent from MSD Portugal and from the entire responsibility of the authors
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None