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Cerebrovascular AccidentNCT00166751

Sonographic Assessment of Laryngeal Elevation

An observational study of Cerebrovascular Accident and Dysphagia, run by National Taiwan University Hospital at 1 site in Taiwan.

Unknown status

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 The sponsor has not verified this record for over two years, so it may be out of date.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

Ultrasonographic examination has long been used to assess the swallowing function. It has the advantages of no ionizing radiation on examination and the possibility of using the real food instead of the barium meal in testing. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cerebrovascular Accident, Dysphagia
How many people
60 participants
Where
1 siteTaiwan
Study dates
Sep 2005to Nov 2006
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 1.stroke with clear consciousness 2.Abnormal videofluoroscopic examination 3.Good cooperation

Who cannot join

  • 1. Lung infection 2. Can not oral feeding

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting
  • Tyng-Guey Wang

    Taipei

    Tyng-Guey Wang, MD, 886-2-23123456 ext. 7588, tgw@ha.mc.ntu.edu.tw

    Yeun-Chung Chang, MD

    Recruiting

Other trials in Taiwan

About this study

Official title: Sonographic Assessment of Laryngeal Elevation in Cerebrovascular Accident Patients With Dysphagia

Ultrasonographic examination has long been used to assess the swallowing function. It has the advantages of no ionizing radiation on examination and the possibility of using the real food instead of the barium meal in testing. Thus, the subjects can be examined repeatedly and in a more physiological status of swallowing. However, the ultrasonographic examination is only used in assessing the oral phase of swallowing. It can accurately visualize the tongue movement, measure the oral transit time of bolus, and sometimes the hypoid bone motion, but has not been applied on the evaluation of pharyngeal phase of swallowing. Physically, laryngeal elevation is an essential component of the swallowing movement on pharyngeal phase. It ensures the occlusion of airway and opening of criopharymgeus muscle, and thus prevents the aspiration. To evaluate the laryngeal elevation is crucial point in managing the dysphagic patients.

The purpose of this project is to measure the laryngeal elevation in normal and in dysphagic patients with cerebrovascular (CVA) accident using ultrasonographic techniques. This work will include four group subjects. The first group consists of 20 young subjects (< 40 years); the second group consists of 20 age-matched normal subjects; the third group consists of 20 CVA patients without swallowing problems, and the fourth group consists of 20 CVA patients with dysphagia, which was proven by VFSS. The laryngeal elevation is detected by ultrasound with the transducer placing between the hyoid bone and thyroid cartilage. The two markers are easily detected on sonogram because of the presence of acoustic shadow, a specific character of bony structure on sonogram. The distance between the hyoid bone and thyroid cartilage before and during swallowing is measures and compared among the groups. The distance change of the patients with dysphagia is further compared with that defined by VFSS. With the result of this study, we will understand the status of laryngeal elevation during swallowing in normal and dysphagic subjects, and further determine the accuracy of ultrasonographic measurement in measuring the laryngeal elevation. With this knowledge, we might extend the usage of ultrasonographic examination on evaluating swallowing function.

Read the detailed description

Dysphagia is a common problem in rehabilitation medicine. To accurately evaluate its disorder is crucial in managing this group patient. Videofluoroscopic examination of swallow (VFSS) is generally regarded as the "gold standard" in the assessment of oropharyngeal dysphagia, especially in the detection of laryngeal penetration or subglottic aspiration. However, its limitations are widely acknowledged. VFSS cannot be performed widely because of its radiation exposure, is a single time measure, where as aspiration may be a variable phenomenon. Moreover, VFSS may over diagnose the disorder of swallowing function since the unflavored barium could disturb deglutition ability of the patients, particularly in those who having impaired cognitive function. As a result, the researchers have sought for more reliable bedside evaluation methods to detect aspiration. Various bedside clinical evaluations such as neurological examination, water swallow test, and swallowing provocation test have been used in identifying predicting or aspiration. However, when considered against the gold standard VFSS, prediction rate for aspiration was still unsatisfactory. Seeking for more non-invasive and objective method of evaluating swallowing function is continuing by many researches.

Ultrasonographic examination has long been used to assess the swallowing function. It has the advantages of no ionizing radiation on examination and the possibility of using the real food instead of the barium meal in testing. Thus, the subjects can be examined repeatedly and in a more physiological status of swallowing. However, the ultrasonographic examination is only used in assessing the oral phase of swallowing. It can accurately visualize the tongue movement, measure the oral transit time of bolus, and sometimes the hypoid bone motion, but has not been applied on the evaluation of pharyngeal phase of swallowing. Physically, laryngeal elevation is an essential component of the swallowing movement on pharyngeal phase. It ensures the occlusion of airway and opening of criopharymgeus muscle, and thus prevents the aspiration. To evaluate the laryngeal elevation is crucial point in managing the dysphagic patients.

The purpose of this project is to measure the laryngeal elevation in normal and in dysphagic patients with cerebrovascular (CVA) accident using ultrasonographic techniques. This work will include four group subjects. The first group consists of 20 young subjects (< 40 years); the second group consists of 20 age-matched normal subjects; the third group consists of 20 CVA patients without swallowing problems, and the fourth group consists of 20 CVA patients with dysphagia, which was proven by VFSS. The laryngeal elevation is detected by ultrasound with the transducer placing between the hyoid bone and thyroid cartilage. The two markers are easily detected on sonogram because of the presence of acoustic shadow, a specific character of bony structure on sonogram. The distance between the hyoid bone and thyroid cartilage before and during swallowing is measures and compared among the groups. The distance change of the patients with dysphagia is further compared with that defined by VFSS. With the result of this study, we will understand the status of laryngeal elevation during swallowing in normal and dysphagic subjects, and further determine the accuracy of ultrasonographic measurement in measuring the laryngeal elevation. With this knowledge, we might extend the usage of ultrasonographic examination on evaluating swallowing function.

Keywords
Videofluoroscopic examination,, ultrasound, laryngeal elevation, dysphagia
Medical subject headings
Stroke, Deglutition Disorders

Timeline

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

  1. First posted14 Sep 2005 (estimated)
  2. Study startSep 2005
  3. Study completionNov 2006

Resources

More details

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

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Other
Enrolment
60 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00166751
Sponsor's protocol ID
9361701221
Status last verified
Dec 2004
First submitted
11 Sep 2005
Last updated
28 Oct 2005
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cerebrovascular Accident and Dysphagia, run by National Taiwan University Hospital at 1 site in Taiwan.

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 1 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 28 Oct 2005. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Tyng-Guey Wang, MD (886-2-23123456 ext. 7588, tgw@ha.mc.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 28 Oct 2005.

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