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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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pleural Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients presenting with dyspnea due to interstitial fibrosis syndrome.
  2. pulmonary edema due to any cause.

Exclusion Criteria:

  1. Traumatic lesions
  2. Pneumothorax
  3. Subcutaneous emphysema
  4. 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

    First Posted
    May 26, 2017
    Last Updated
    May 30, 2017
    Sponsor
    Assiut University
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    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
    background

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    Transthoracic Sonography Versus High Resolution Computed Tomography in Alveolar Intersitial Syndrome

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