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.
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
- Recruiting
Tyng-Guey Wang
Taipei
Tyng-Guey Wang, MD, 886-2-23123456 ext. 7588, tgw@ha.mc.ntu.edu.tw
Yeun-Chung Chang, MD
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.
- Conditions
- Cerebrovascular Accident, Dysphagia
- 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.
- First posted14 Sep 2005 (estimated)
- Study startSep 2005
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Tyng-Guey Wang, MD, Principal investigator, National Taiwan University, School of Medicine, National Taiwan University
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonographic Assessment of Laryngeal Elevation in Cerebrovascular Accident Patients With Dysphagia
- ClinicalTrials.gov ID
- NCT00166751
- Acronym / sponsor ID
- 9361701221
- Conditions
- Cerebrovascular Accident, Dysphagia
- Keywords
- Videofluoroscopic examination,, ultrasound, laryngeal elevation, dysphagia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Nov 2006
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.stroke with clear consciousness 2.Abnormal videofluoroscopic examination 3.Good cooperation
Key exclusion criteria (1 listed)
- 1. Lung infection 2. Can not oral feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2005.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyng-Guey Wang, MD principal investigator
National Taiwan University, School of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
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.