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To Evaluate Oral Phase Swallowing Function Using Submental Ultrasound

Primary Purpose

Dysphagia

Status
Available
Phase
Locations
Study Type
Expanded Access
Intervention
Ultrasound
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Dysphagia focused on measuring Videofluoroscopic, swallowing, study, (VFSS), ultrasound

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria:

  • >= 20 yers

Exclusion Criteria:

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 10, 2008
    Last Updated
    September 12, 2008
    Sponsor
    National Taiwan University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00752349
    Brief Title
    To Evaluate Oral Phase Swallowing Function Using Submental Ultrasound
    Official Title
    To Evaluate Oral Phase Swallowing Function Using Submental Ultrasound
    Study Type
    Expanded Access

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Available
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Taiwan University Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Ultrasound is widely applied in many fields of medicine but less commonly used in the evaluation of tongue movement and swallowing abnormality. Fuhrman RAW reported the usefulness of using ultrasound to evaluate poor tongue coordination [1]. Peng CL stated that ultrasound could provide excellent quantitative and qualitative bases of tongue movement during swallowing using cushion-scan technique [2]. Videofluoroscopic swallowing study (VFSS) is widely accepted as the gold standard of evaluating swallowing abnormality because it is able to evaluate the whole swallowing procedure without interference of pharyngeal contraction and foreign body sensation when swallowing is examined by using a fiber-optic laryngoscope. One of the most important information that VFSS can provide is the detection of subclinical silent aspiration. The decision and management of many patients with swallowing abnormalities are usually based on the VFSS findings [3]. As shown in many reports, our experiences showed that VFSS provided extremely important information of understanding the pathophysiologic change of dysphagia due to variable etiologies, such as in patients with nasopharyngeal cancer suffering from radiation therapy [4] and in patients with stroke [5]. Using the findings of VFSS, physicians and medical staffs can make important decision whether oral feeding should be given, which safety swallowing maneuver works and what is the appropriate choices of food consistency safe to dysphagic patients. The difficulties of VFSS are usually in the transportation of paraplegic and hemiplegic patients from ward to the examining chair. The frequency and examination duration of VFSS is usually limited for avoiding unnecessary radiation exposure. Hence, ultrasound provides a role in evaluating oral condition with the benefits of convenience of transportation and availability as well as no radiation exposure. Therefore, validation of the value of ultrasound for the oral swallowing with correlation of VFSS is important to test the clinical feasibility. Peng CL et al reported their experiences of using real-time ultrasound in the evaluation of intrinsic tongue movement [2, 6, 7]. The findings of submental ultrasound are quite different from the findings of VFSS which provides the surface information of the tongue in the swallowing of radiopaque barium sulfate bolus. Combined real-time B mode and M mode ultrasound, it was reported the potential of digital data analysis of oral phase swallowing. Kuhl V et al reported the usefulness of ultrasound in the evaluation of laryngeal elevation in patients with dysphagia [8]. They found significant decrease of laryngeal elevation in patients diagnosed as neurogenic dysphasia [8]. Casas et al successfully combined ultrasound examination and plethysmography to evaluate the swallowing condition of children with cerebral palsy [9]. The results of these studies explained the potential of ultrasound in oral swallowing and dynamic laryngeal movement. Our experiences of VFSS showed the usefulness VFSS in diagnosing and management of patients with swallowing problem or dysphagia [4, 5, 10, 11]. To our knowledge, there was little experience of comparing between ultrasound and VFSS in patients with swallowing problem. Therefore, we conducted this study to correlate submental ultrasound and VFSS findings and tried to find out the clinical feasibility and usefulness. Purposes: This study was to evaluate the usefulness of submental ultrasound (SM US) in oral phase swallowing in correlation with videofluoroscopic study (VFSS). To compare normal volunteers and patients with swallowing abnormality with submental ultrasound. To evaluate and compare patients with swallowing problem using submental ultrasound and VFSS. Type of study: Retrospective. Time of study: Jan 2004 - July 2006.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dysphagia
    Keywords
    Videofluoroscopic, swallowing, study, (VFSS), ultrasound

    7. Study Design

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Ultrasound
    Intervention Description
    To evaluate oral phase swallowing function using submental ultrasound

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Eligibility Criteria
    Inclusion Criteria: >= 20 yers Exclusion Criteria:
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Chang Yeun-Chung, Ph.D
    Phone
    886-2-23123456
    Ext
    65566
    Email
    ycc5566@ntu.edu.tw

    12. IPD Sharing Statement

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