Transthoracic Sonography Versus High Resolution Computed Tomography in Alveolar Intersitial Syndrome
Primary Purpose
Pleural Diseases
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High resolution computed tomography
trans thoracic ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Pleural Diseases
Eligibility Criteria
Inclusion Criteria:
- Patients presenting with dyspnea due to interstitial fibrosis syndrome.
- pulmonary edema due to any cause.
Exclusion Criteria:
- Traumatic lesions
- Pneumothorax
- Subcutaneous emphysema
- Massive pleural effusion with atelectasis, and
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
High Resolution computed tomography
Arm Description
Patients will be included in the study when High resolution chest computed tomography without contrast enhancement is ordered by the primary physician. Before the High resolution chest computed tomography scan, a Trans thoracic ultrasonography will be performed.
Outcomes
Primary Outcome Measures
the number of patients diagnosed with pleural diseases by high resolution computed tomography
computed tomography on the chest
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03172585
Brief Title
Transthoracic Sonography Versus High Resolution Computed Tomography in Alveolar Intersitial Syndrome
Official Title
Can High Frequency Transthoracic Sonography Play a Competition Role With High Resolution Computed Tomography in Assessment of Alveolar Intersitial Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases. However, the associated high expenses, radiation exposure , and its limited possibility for bedside use are a limitation.
Detailed Description
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases. However, the associated high expenses, radiation exposure , and its limited possibility for bedside use are a limitation. Transthoracic ultrasonograghy is used progressively for evaluation of pulmonary diseases. Its non invasive nature , relatively low price ,portability for bedside use, and high reproducibility of results allows for incorporation of imaging findings with clinical data. Although Transthoracic ultrasonograghy is not an alternative to High resolution computed tomography,it can potentially provide useful supplemental information in certain specific situations ,such as for rapid bedside diagnostic assessment of dyspneic patients. B-line is a common and significant abnormal sign used for diagnostic appraisal by Transthoracic ultrasonograghy, but it cannot define the exact underlying pathologic feature on a lung ultrasound. When the lung parenchymal pathology reaches the lung surface ,certain characteristic changes of the pleural line can be detected by means of the good imaging made possible by high-resolution Transthoracic ultrasonograghy ,but the application and strength of pleural line abnormalities in the differential diagnosis of lung diseases has not been adequately explored . Existing literature on the illustration of the pleural line is scarce ,and the shape of pleural line has not been adequately investigated and described ,especially in comparison with Computed tomography findings. Most studies that have investigated pleural lines are confined to the sub population with interstitial lung diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Diseases
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Resolution computed tomography
Arm Type
Other
Arm Description
Patients will be included in the study when High resolution chest computed tomography without contrast enhancement is ordered by the primary physician. Before the High resolution chest computed tomography scan, a Trans thoracic ultrasonography will be performed.
Intervention Type
Other
Intervention Name(s)
High resolution computed tomography
Intervention Description
High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases
Intervention Type
Other
Intervention Name(s)
trans thoracic ultrasonography
Intervention Description
Trans thoracic ultrasonograghy is used progressively for evaluation of pulmonary diseases . Its non invasive nature , relatively low price ,portability for bedside use, and high reproducible of results allows for incorporation of imaging findings with clinical data
Primary Outcome Measure Information:
Title
the number of patients diagnosed with pleural diseases by high resolution computed tomography
Description
computed tomography on the chest
Time Frame
30 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with dyspnea due to interstitial fibrosis syndrome.
pulmonary edema due to any cause.
Exclusion Criteria:
Traumatic lesions
Pneumothorax
Subcutaneous emphysema
Massive pleural effusion with atelectasis, and
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gamal Rabeea, MD
Phone
00201221729476
Email
gamalagmy135@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed Fawzy, MD
Phone
00201003032335
Email
mohamedadam200010@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manal Mohamed, MD
Organizational Affiliation
Assiut University
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
21160921
Citation
Sartori S, Tombesi P. Emerging roles for transthoracic ultrasonography in pleuropulmonary pathology. World J Radiol. 2010 Feb 28;2(2):83-90. doi: 10.4329/wjr.v2.i2.83.
Results Reference
background
PubMed Identifier
15888804
Citation
Frenz MB, Mee AS. Diagnostic radiation exposure and cancer risk. Gut. 2005 Jun;54(6):889-90. doi: 10.1136/gut.2005.066605. No abstract available.
Results Reference
background
PubMed Identifier
16984837
Citation
Volpicelli G, Mussa A, Garofalo G, Cardinale L, Casoli G, Perotto F, Fava C, Frascisco M. Bedside lung ultrasound in the assessment of alveolar-interstitial syndrome. Am J Emerg Med. 2006 Oct;24(6):689-96. doi: 10.1016/j.ajem.2006.02.013.
Results Reference
background
PubMed Identifier
23937897
Citation
Smargiassi A, Inchingolo R, Soldati G, Copetti R, Marchetti G, Zanforlin A, Giannuzzi R, Testa A, Nardini S, Valente S. The role of chest ultrasonography in the management of respiratory diseases: document II. Multidiscip Respir Med. 2013 Aug 9;8(1):55. doi: 10.1186/2049-6958-8-55.
Results Reference
background
PubMed Identifier
25545613
Citation
Leech M, Bissett B, Kot M, Ntoumenopoulos G. Lung ultrasound for critical care physiotherapists: a narrative review. Physiother Res Int. 2015 Jun;20(2):69-76. doi: 10.1002/pri.1607. Epub 2014 Dec 29.
Results Reference
background
PubMed Identifier
9372688
Citation
Lichtenstein D, Meziere G, Biderman P, Gepner A, Barre O. The comet-tail artifact. An ultrasound sign of alveolar-interstitial syndrome. Am J Respir Crit Care Med. 1997 Nov;156(5):1640-6. doi: 10.1164/ajrccm.156.5.96-07096.
Results Reference
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Transthoracic Sonography Versus High Resolution Computed Tomography in Alveolar Intersitial Syndrome
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