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Comparison of diaphragm movement measurement method between M-mode ultrasonography and fluoroscopy

Status Approved

  • First Submitted Date

    2017/09/28

  • Registered Date

    2018/01/09

  • Last Updated Date

    2017/11/13

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0002654
    Unique Protocol ID RM17-11
    Public/Brief Title Comparison of diaphragm movement measurement method between M-mode ultrasonography and fluoroscopy
    Scientific Title Comparison of diaphragm movement measurement method between M-mode ultrasonography and fluoroscopy
    Acronym
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number RM17-11
    Approval Date 2017-09-05
    Institutional Review Board Name Bundang Jesaeng Hospital Institutional Review Board
    Institutional Review Board Address
    Institutional Review Board Telephone
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Seo Yeon Yoon
    Title Dr.
    Telephone +82-31-779-0627
    Affiliation Bundang Jesaeng Hospital
    Address 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
    Contact Person for Public Queries
    Name Seo Yeon Yoon
    Title Dr.
    Telephone +82-31-779-0627
    Affiliation Bundang Jesaeng Hospital
    Address 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
    Contact Person for Updating Information
    Name Seo Yeon Yoon
    Title Dr.
    Telephone +82-31-779-0627
    Affiliation Bundang Jesaeng Hospital
    Address 20, Seohyeon-ro 180beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Not yet recruiting
    Date of First Enrollment 2017-11-30 Anticipated
    Target Number of Participant 50
    Primary Completion Date 2018-02-28 , Anticipated
    Study Completion Date 2018-02-28 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Bundang Jesaeng Hospital
    Recruitment Status Not yet recruiting
    Date of First Enrollment 2017-11-30 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Bundang Jesaeng Hospital
    Organization Type Medical Institute
    Project ID RM17-11
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Bundang Jesaeng Hospital
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Patients with central nervous system disorders are not only paralyzed by the arms, legs, and trunk, but they often have decreased pulmonary function. Pulmonary function tests are often used to evaluate respiratory function, and another important thing to measure is the movement of the diaphragm. Especially, patients with cervical spinal cord injury are more likely to have diaphragmatic paralysis depending on the level of cervical involvement. Various methods such as fluoroscopy, CT, MRI, and ultrasonography can be used to measure diaphragm movements. Among these, fluoroscopy can be used to measure diaphragm motion easily and visually by using X-ray, which is a commonly used method, but it has a drawback that it is exposed to radiation and requires a machine. The method of viewing the diaphragm movement using the M-mode of ultrasonography has been tried in several papers, and it can be easily performed on the bedside and it is advantageous that it is not exposed to radiation. There is no study on the gold standard to measure diaphragm movement. A previous study of diaphragmatic movement measurement using both fluoroscopy and ultrasonography has been performed in 14 normal subjects and the two methods have been reported to be highly correlated. In this study, we will compare the diaphragmatic movement using fluoroscopy and M-mode ultrasonography in patients with central nervous system disorder, which is expected to have decreased pulmonary function. We will evaluate whether there is a more relevant method of evaluating pulmonary function among the two methods. 
    From October 2017, we will enroll the patients with central nervous system disorder hospitalized for rehabilitation. Pulmonary function test including Functional vital capacity (FVC), FEV1 (Forced expiratory volime), FEV1/FVC, PCF (Peak cough flow), MIP (Maximal inspiratory pressure), MEP (Maximal expiratory pressure) is performed by initial patient evaluation at admission and diaphragm movement is measured by M-mode ultrasonography and fluoroscopy. For the measurement of the diaphragm movement with fluoroscopy, the patient rests comfortably and breathes three times. The average value of the three measurement is recorded. The measurement time is within 2 minutes. When measuring the diaphragm movement using M-mode ultrasonography, the patient lie in a relaxed state, and a curved linear probe is placed between the mid-axillary line and the mammillary line and tilted 45 ' upward. And the average value of the three measurement is recorded. The measurement time is less than 5 minutes. Correlation analysis will be performed right and left sides separately, in order to check the degree of correlation between two mothods. Correlation analysis is performed to determine the measurement methods that are more relevant to FVC, FEV1, FEV1 / FVC, PCF, MIP, and MEP. Statistical analysis was performed using SPSS 20.0 and statistically significant at p <0.05.
    
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-only
    Time Perspective Cross-sectional  
    Target Number of Participant 50
    Cohort/Group Number 1
    Cohort/
    Group 1

    Cohort/Group Label

    Patients with central nervous system disorder

    Cohort/Group Description

    We will measure the diaphragm movement using fluoroscopy and ultrasonography for patients with central nervous system disease who were hospitalized at Bundang Sacrifice Hospital. Identify the degree of association between the two methods and identify which of the two methods is more relevant to the assessment of pulmonary function.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients with central nervous system disorder who are admitted to Bundal Jesaeng Hospital for inpatient rehabilitation
    Sampling Method
    consecutively enroll central nervouw system disorder patients who are admitted for inpatient rehabilitation.
    Condition(s)/Problem(s) * (I00-I99)Diseases of the circulatory system 
       (I64)Stroke, not specified as haemorrhage or infarction 
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    No Limit~No Limit

    Description

    1) Patients with central nervous system disorders ((Stroke, Traumatic brain injury, Parkinson disease, spinal cord injury, etc.)
    2) Patients with intact cognitive fuction who can perform pulmonary function test 
    
    Exclusion Criteria
    1) Patients wigh poor congnitive functions who cannot perform pulmonary function test 
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome clinical-equivalence
    Primary Outcome(s) 1
    Outcome
    Diaphragm movement 
    Timepoint
    on admission
    Secondary Outcome(s) 1
    Outcome
    pulmonary function test (Forced vital capacity, Forced expiratory volume1, FEV1/FVC, Peak cough flow, Maximal inspiratory pressure, Maximal expiratory pressure)
    Timepoint
    on admission
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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