PneumoniaPOCUS-LNCT06296693
Diagnostic Accuracy of Pocket-size Lung Ultrasound in Pneumonia Etiology and Complications in Hospitalized Children
A study testing Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized in people with Pneumonia and Pneumonia, Viral, run by Centro Hospitalar Universitário de Santo António.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial
- What is being tested?
- Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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)
Who cannot join
- Nosocomial pneumonia
- Cystic fibrosis diagnosis
- Long-term use of domiciliary ventilation.
Trial locations and contacts
No sites are listed yet.
About this study
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
- 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.
- 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.
- 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.
- 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.
- 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.
- When is the study starting and how long is it expected to run for:
The recruitment period is expected to start in January/2024 and end in January 2025.
Read the 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 smartphone/tablet. 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.
- Conditions
- Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial
- Being tested
- Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized
- Keywords
- bacterial pneumonia, community-acquired pneumonia, chest radiograph, digital health, POCUS, viral pneumonia
- Medical subject headings
- Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalizedDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of follow-up at 1 month
Secondary outcomes (3)
CXR image vs. ultrasound
Correlation between CXR image vs. ultrasound.
The ultrasound findings will be compared with the radiological findings concerning at least one: lung consolidations, air bronchogram, pleural abnormalities, interstitial infiltrates.
Measured: From enrollment to the end of follow-up at 1 month
Clinical progression and ultrasound images
Correlation between clinical progression and ultrasound images.
Clinical progression will include three main symptoms: cough, shortness of breath and fever. POCUS findings over time (admission, daily during hospitalization, 15 days after discharge and 1 month after discharge) will include: lung consolidations, air bronchogram, shred sign, pleural abnormalities, variable number and coalescence of B-lines.
Measured: From enrollment to the end of follow-up at 1 month
Complications
Diagnostic accuracy to detect complications.
Complications will include the detection of at least one: pleural effusion, necrotizing pneumonia, lung abscess and pneumothorax on both POCUS and CXR.
Measured: From enrollment to the end of follow-up at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Hospitalar Universitário de Santo António
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Monteiro, Centro Hospitalar Universitário de Santo António
- Investigators
- Sara Monteiro, Principal investigator, Centro Hospitalar Universitário de Santo António
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06296693
- Sponsor's protocol ID
- 2023.062(051-DEFI/053-CE)
- Acronym
- POCUS-L
- Status last verified
- Mar 2024
- First submitted
- 29 Dec 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06296693
- Acronym / sponsor ID
- POCUS-L / 2023.062(051-DEFI/053-CE)
- Conditions
- Pneumonia, Pneumonia, Viral, Pneumonia, Bacterial
- Keywords
- bacterial pneumonia, community-acquired pneumonia, chest radiograph, digital health, POCUS, viral pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Centro Hospitalar Universitário de Santo AntónioUniversity, hospital or other
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 6 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
- 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.
- 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.
- 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.
- 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.
- When is the study starting and how long is it expected to run for:
The recruitment period is expected to start in January/2024 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 smartphone/tablet. 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| POCUS-L | Experimental | Device: Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalizedThe 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. |
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (3 listed)
- Nosocomial pneumonia
- Cystic fibrosis diagnosis
- Long-term use of domiciliary ventilation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalizedThe 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 | POCUS-L |
Primary outcome
POCUS vs. CXR for the etiological diagnosis of CAP
Time frame: From enrollment to the end of follow-up at 1 month
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.
3 secondary outcomes
CXR image vs. ultrasound
Time frame: From enrollment to the end of follow-up at 1 month
Clinical progression and ultrasound images
Time frame: From enrollment to the end of follow-up at 1 month
Complications
Time frame: From enrollment to the end of follow-up at 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Monteiro principal investigator
Centro Hospitalar Universitário de Santo António
Questions about this trial
What is this clinical trial studying?
A study testing Pocket-size lung ultrasound for etiological definition of pneumonia and surveillance of complications in children hospitalized in people with Pneumonia and Pneumonia, Viral, run by Centro Hospitalar Universitário de Santo António.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Monteiro (+351 914272547, saraapmonteiro@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POCUS vs. CXR for the etiological diagnosis of CAP (time frame: From enrollment to the end of follow-up at 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.