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DysphagiaNCT00752349

To Evaluate Oral Phase Swallowing Function Using Submental Ultrasound

A study testing Ultrasound in people with Dysphagia, run by National Taiwan University Hospital.

Available

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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]. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Dysphagia
What is being tested?
Ultrasound
How many people
Not given
Where
No sites listed yet
Study dates
Start not givento not given
Phase
Expanded access
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 20 years and older
  • All sexes
  • Adult, Older adult

Who may be able to join

  • >= 20 yers

Who cannot join

None listed.

Trial locations and contacts

No sites are listed yet.

Chang Yeun-Chung, Ph.D contact

886-2-23123456 ext. 65566

ycc5566@ntu.edu.tw

About this study

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.

Read more

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).

  1. To compare normal volunteers and patients with swallowing abnormality with submental ultrasound.
  2. To evaluate and compare patients with swallowing problem using submental ultrasound and VFSS.

Type of study: Retrospective. Time of study: Jan 2004 - July 2006.

Conditions
Dysphagia
Being tested
Ultrasound
Keywords
Videofluoroscopic, swallowing, study, (VFSS), ultrasound
Medical subject headings
Deglutition Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundProcedure or surgery

    To evaluate oral phase swallowing function using submental ultrasound

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Expanded access
IDs, dates and publications
ClinicalTrials.gov ID
NCT00752349
Sponsor's protocol ID
200702029R
Status last verified
Sep 2008
First submitted
10 Sep 2008
Last updated
15 Sep 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound in people with Dysphagia, run by National Taiwan University Hospital.

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 1 inclusion and 0 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 15 Sep 2008. 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 Chang Yeun-Chung, Ph.D (886-2-23123456 ext. 65566, ycc5566@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

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 15 Sep 2008.

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