Lung DiseasesNCT04326972
Diagnostic Value of Chest Ultrasound in Pediatrics Lung Diseases
An observational study of Lung Diseases, run by Assiut University.
Trial summary
To evaluate the accuracy of chest ultrasound for diagnosis of different lung lesions in comparison to the gold standard among children. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Lung Diseases
- What is being tested?
- ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2020to Nov 2021
- Phase
- Observational
- 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 29 days to 18 years
- All sexes
- Child, Adult
Study population: The pediatric patients admitted in ER \&chest wards in Assiut University Children Hospital .
Who may be able to join
- Age more than twenty eight day up to 18 yrs .
- Patients admitted in ER \&chest wards ,with history of fever cough and dyspnea .
- Chest X ray opacity on recent admission .
- Patients who developed acute chest infection on top of chronic respiratory disease .
Who cannot join
- • Neonate .
- Chronic disease as cardiac disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Diagnostic Value of Chest Ultrasound in Detecting Causes of Radiological Opacities in Comparison to CT Scan Among Children at Assiut University Children Hospital
To evaluate the accuracy of chest ultrasound for diagnosis of different lung lesions in comparison to the gold standard among children.
Read the detailed description
Lung disease are the most common condition in pediatrics and also the primary cause of death among children less than 5 years old(Chen Shui-Wen et al.,2015).
Chest X ray consider as the first line to evalute the chest disease (Kim O et al. ,2000), in identified the pulmonary opacities (Ozkaya A et al., 2018),but there is limitation in the interpretation of the location and nature of an area of increase opacity on chest radiographs particularly in young infants with varied configuration of thymus and differentiation between pulmonary , pleural and mediastinal lesions is not always easy(Barillari A et al .,2011),so the thoracic computed tomography is recommended as diagnostic gold standard to follow up pediatric chest X ray opacities and masses(Lameh A et al. ,2019),but not consider as first line of radiological evaluation because each chest computed tomography gives to patient an effective dose of eight msv equivalent to four hundred chest X ray (Prithviraj D.,2014), also high cost ,and longe waiting times for imaging (Lameh A et al .,2019).
Chest sonography consider as first line investigation in evaluation of diaphragmatic ,pleural and chest wall lesions due to lack of superficial adipose tissue in pediatric patients (Goh Y, et al. ,2016),but undervalued for lungs lesion for many years ,because the ribs ,sternum and aerated lungs had been considered obstacles to ultrasound waves (Dietrich C, et al., 2015). However improvements in technology have lead to production of higher-resolution transducers and techniques such as tissue harmonic imaging, which lead to improved spatial resolution and deeper tissue penetration of ultrasound waves (Lameh A et al. ,2019),also the pathological processes as inflammations ,trauma or neoplastic within the chest wall ,pleural, and lungs result in profound changes in tissue composition and improved acoustic transmission and allow for adequate lungs sonographic evaluation(Dietrich C, et al., 2015).
Chest sonography serves as a powerful complementary diagnostic tool with advantage of easy availability ,rapid ,radiation free (Dietrich C, et al., 2015), repeatable and inexpensive methods, determining the high diagnostic accuracy in detecting pediatric chest lesions (Lameh A et al .,2019).
Causes of pediatric chest X ray opacity:
Radio-opacities are more common and significant compared to increased radiolucency , can be caused by many different pathologies and present with different patterns (Gelaw S.,2015), as:
Consolidation:
Caused by replacement of the air in distal airways and the alveoli by fluid or soft tissues. Radiological, this is seen as opacity of any size and mostly homogenous, it has no volume loss, has the tendency to coalescence, has ill-defined margins, non-segmental distribution, irregular shape, air bronchogram (Gelaw S.,2015).
By ultrasound its similar in echogenicity and echotexture to liver and spleen. Bronchograms present within the solid appearing area of echogenicity as multiple bright dot like , and branching linear structures represent air in bronchi and scattered residual air in alveoli(Barillari A et al. ,2011).
Differentiate from atelectasia by presence of dynamic air bronchogram (Barillari A et al .,2011).
Collapse (atelectasis):
This may affect the whole hemi-lung or sub-division of the lungs, such as the lobes , segments or subsegments of the lung. Radiological, it causes opacity and signs of volume loss(Gelaw S.,2015).
It is important to to differentiate focal areas of cosolidation from those of collapse ,since collapse may be associated with a foreign body inhalation or other extrinisic obstruction (Arthur R.,2003) . By chest ultrasound atelectasis similar in echogenicity and echotexture to liver and the air broncograms appear crowded and parallel (Barillari A et al.,2011).
Interstitial opacities:
This is the common presentation of chronic diffuse interstitial lung diseases (Gelaw S.,2015).
Lung ultrasound is an emerging tool in diagnosis of interstitial lung diseases by evaluation number of B lines ,pleural irregularities and nodules or consolidation (Falcetta et al., 2018).
Pleural/chest wall opacities:
Pleural opacities, such as pleural mass lesion, pleural thickening or calcification or mass arising from soft tissue or bony chest wall (Gelaw S., 2015) , in the pleural effusion is challenging to differentiate between the pleural effusion and consolidation by the X ray especially in hemithorax (Prina E., 2014).ultrasound provides detailed information about the nature of pleural fluid and allows one to determine whether a fluid collection is amenable to aspiration (Kim O et al., 2000).
Nodular opacities or mass:
These are rounded increased opacities that can be caused by different pathologies. Radiological , these can be seen on any location, with sizes ranging from pinpoint to mass (it is called mass if >3 cm), solitary or multiple (such as miliary nodules, if multiple small nodules ≈2 mm in diameter), can have different shapes; and margins can be smooth, umbilicated or lobulated. The outline can be sharp, ill-defined or speculated (Gelaw S.,2015).
Ring opacities:
These are annular opacities with central radiolucency usually due to cavitations of pre-existing lesion, but also can be caused by bullae, benign air cyst, loculated pneumothorax or fibrocystic changes (Gelaw S.,2015).
Linear opacities:
These are thin or thick (band shadow, if 5 mm or more) linear shadows. The most common abnormal linear opacity is a scar. Post-primary tuberculosis commonly heals with fibrosis presenting with irregular linear opacities with or without volume loss (Gelaw S.,2015).
- Conditions
- Lung Diseases
- Being tested
- ultrasound
- Medical subject headings
- Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
- All patients with inclusion criteria do for them chest ultrasound .
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Value of Chest Ultrasound in Detecting causes of Radiological Opacities in Comparison to CT scan Among Children at Assiut University Children Hospital
To evaluate the accuracy of chest ultrasound for diagnosis of different lung lesions in comparison to the gold standard among children
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 Oct 2020 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhekra Ashour Aboud Salem, Assiut University
- Investigators
- Fatma Hassan, professor, Study director, Assiut UniversityYasser Rezk, Lecturer, Study director, Assiut UniversityMohamed Aboelela, Lecturer, Study director, Assiut UniversitySahar Youssif, Lecturer, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326972
- Sponsor's protocol ID
- chest ultrasound in pediatrics
- Status last verified
- Mar 2020
- First submitted
- 27 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Chest Ultrasound in Detecting Causes of Radiological Opacities in Comparison to CT Scan Among Children at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT04326972
- Acronym / sponsor ID
- chest ultrasound in pediatrics
- Conditions
- Lung Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 30 Mar 2020 (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.
To evaluate the accuracy of chest ultrasound for diagnosis of different lung lesions in comparison to the gold standard among children.
Detailed description
Lung disease are the most common condition in pediatrics and also the primary cause of death among children less than 5 years old(Chen Shui-Wen et al.,2015).
Chest X ray consider as the first line to evalute the chest disease (Kim O et al. ,2000), in identified the pulmonary opacities (Ozkaya A et al., 2018),but there is limitation in the interpretation of the location and nature of an area of increase opacity on chest radiographs particularly in young infants with varied configuration of thymus and differentiation between pulmonary , pleural and mediastinal lesions is not always easy(Barillari A et al .,2011),so the thoracic computed tomography is recommended as diagnostic gold standard to follow up pediatric chest X ray opacities and masses(Lameh A et al. ,2019),but not consider as first line of radiological evaluation because each chest computed tomography gives to patient an effective dose of eight msv equivalent to four hundred chest X ray (Prithviraj D.,2014), also high cost ,and longe waiting times for imaging (Lameh A et al .,2019).
Chest sonography consider as first line investigation in evaluation of diaphragmatic ,pleural and chest wall lesions due to lack of superficial adipose tissue in pediatric patients (Goh Y, et al. ,2016),but undervalued for lungs lesion for many years ,because the ribs ,sternum and aerated lungs had been considered obstacles to ultrasound waves (Dietrich C, et al., 2015). However improvements in technology have lead to production of higher-resolution transducers and techniques such as tissue harmonic imaging, which lead to improved spatial resolution and deeper tissue penetration of ultrasound waves (Lameh A et al. ,2019),also the pathological processes as inflammations ,trauma or neoplastic within the chest wall ,pleural, and lungs result in profound changes in tissue composition and improved acoustic transmission and allow for adequate lungs sonographic evaluation(Dietrich C, et al., 2015).
Chest sonography serves as a powerful complementary diagnostic tool with advantage of easy availability ,rapid ,radiation free (Dietrich C, et al., 2015), repeatable and inexpensive methods, determining the high diagnostic accuracy in detecting pediatric chest lesions (Lameh A et al .,2019).
Causes of pediatric chest X ray opacity:
Radio-opacities are more common and significant compared to increased radiolucency , can be caused by many different pathologies and present with different patterns (Gelaw S.,2015), as:
Consolidation:
Caused by replacement of the air in distal airways and the alveoli by fluid or soft tissues. Radiological, this is seen as opacity of any size and mostly homogenous, it has no volume loss, has the tendency to coalescence, has ill-defined margins, non-segmental distribution, irregular shape, air bronchogram (Gelaw S.,2015).
By ultrasound its similar in echogenicity and echotexture to liver and spleen. Bronchograms present within the solid appearing area of echogenicity as multiple bright dot like , and branching linear structures represent air in bronchi and scattered residual air in alveoli(Barillari A et al. ,2011).
Differentiate from atelectasia by presence of dynamic air bronchogram (Barillari A et al .,2011).
Collapse (atelectasis):
This may affect the whole hemi-lung or sub-division of the lungs, such as the lobes , segments or subsegments of the lung. Radiological, it causes opacity and signs of volume loss(Gelaw S.,2015).
It is important to to differentiate focal areas of cosolidation from those of collapse ,since collapse may be associated with a foreign body inhalation or other extrinisic obstruction (Arthur R.,2003) . By chest ultrasound atelectasis similar in echogenicity and echotexture to liver and the air broncograms appear crowded and parallel (Barillari A et al.,2011).
Interstitial opacities:
This is the common presentation of chronic diffuse interstitial lung diseases (Gelaw S.,2015).
Lung ultrasound is an emerging tool in diagnosis of interstitial lung diseases by evaluation number of B lines ,pleural irregularities and nodules or consolidation (Falcetta et al., 2018).
Pleural/chest wall opacities:
Pleural opacities, such as pleural mass lesion, pleural thickening or calcification or mass arising from soft tissue or bony chest wall (Gelaw S., 2015) , in the pleural effusion is challenging to differentiate between the pleural effusion and consolidation by the X ray especially in hemithorax (Prina E., 2014).ultrasound provides detailed information about the nature of pleural fluid and allows one to determine whether a fluid collection is amenable to aspiration (Kim O et al., 2000).
Nodular opacities or mass:
These are rounded increased opacities that can be caused by different pathologies. Radiological , these can be seen on any location, with sizes ranging from pinpoint to mass (it is called mass if >3 cm), solitary or multiple (such as miliary nodules, if multiple small nodules ≈2 mm in diameter), can have different shapes; and margins can be smooth, umbilicated or lobulated. The outline can be sharp, ill-defined or speculated (Gelaw S.,2015).
Ring opacities:
These are annular opacities with central radiolucency usually due to cavitations of pre-existing lesion, but also can be caused by bullae, benign air cyst, loculated pneumothorax or fibrocystic changes (Gelaw S.,2015).
Linear opacities:
These are thin or thick (band shadow, if 5 mm or more) linear shadows. The most common abnormal linear opacity is a scar. Post-primary tuberculosis commonly heals with fibrosis presenting with irregular linear opacities with or without volume loss (Gelaw S.,2015).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- The pediatric patients admitted in ER \&chest wards in Assiut University Children Hospital .
Key inclusion criteria (4 listed)
- Age more than twenty eight day up to 18 yrs .
Key exclusion criteria (2 listed)
- • Neonate .
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 |
|---|---|---|
| ultrasound• All patients with inclusion criteria do for them chest ultrasound . | Device | – |
Primary outcome
Diagnostic Value of Chest Ultrasound in Detecting causes of Radiological Opacities in Comparison to CT scan Among Children at Assiut University Children Hospital
Time frame: baseline
To evaluate the accuracy of chest ultrasound for diagnosis of different lung lesions in comparison to the gold standard among children
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
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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.
Fatma Hassan, professor study director
Assiut University
Yasser Rezk, Lecturer study director
Assiut University
Mohamed Aboelela, Lecturer study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by Assiut University.
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 4 inclusion and 2 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 30 Mar 2020. 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 Dhekra Salem, M.S.C (01140856720, pediaosha30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic Value of Chest Ultrasound in Detecting causes of Radiological Opacities in Comparison to CT scan Among Children at Assiut University Children Hospital (time frame: baseline). 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 30 Mar 2020.