Screening of Dysphagia Via Ultrasonography in Patients With Stroke

Stroke Clinical Trial

Official title:

Evaluation of Ultrasonography as a Screening Tool for Dysphagia in Patients With Stroke: Correlation With Videofluoroscopic Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04344392
• Other study ID #: 71306642-050.05.05.04
• Status: Completed
• Phase: N/A
• Start date: January 22, 2022
• Est. completion date: January 1, 2023

Study information

• Verified date: March 2023
• Source: Bezmialem Vakif University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Oropharyngeal dysphagia is commonly seen in patients with stroke. Clinical assessment may be used to evaluate dysphagia in patients with stroke however reliability of this method is controversial and videofluoroscopic study is still considered as gold standard. However, exposure to radiation, necessity for a experienced practitioner, an expensive device, and swallowing contrast agents are disadvantages of videofluoroscopy. Ultrasonography, on the other hand, is a cheap, noninvasive device which may demonstrate tongue and laryngeal movement dynamically. In this manner, this study aims to evaluate whether ultrasound can assess dysphagia in patients with hemiplegia accurately.

Description:

For a safe swallowing tongue muscles must function properly and larynx should replace superoanterior to close trachea via stretching cricopharyngeal muscle. In this context, approximation of thyroid cartilage and larynx is important for swallowing. These mechanisms are impaired in stroke, Parkinson's disease, traumatic brain injury, and neuromuscular disorders thus resulting oropharyngeal dysphagia. Clinical examination may be used for assessing dysphagia in those patients however reliability of this method is controversial and videofluoroscopic study is considered as gold standard for assessing dysphagia. Ultrasound is used to assess swallowing functions since 1970s however, the studies commonly focused on tongue thickness and functions. Due to advances in technology besides tongue thickness, ultrasonography may practically demonstrate how larynx and thyroid cartilage approximate and hor larynx moves anteriorly. In literature, three methods came to forefront as evaluation methods for dysphagia: 1) approximation of thyroid cartilage and hyoid bone (THA), 2) tongue thickness in rest (TT), and 3) hyoid bone anterior replacement (HAR). In previous studies, the efficiency of THA for assessing dysphagia via videofluoroscopic study has been demonstrated. However other methods have not been evaluated in dysphagic patients with stroke. Ultrasonography, as a cheap, portable and non-invasive method, is a promising for assessing dysphagia in patients with stroke. In this context, this study aims to test the reliability and efficacy of these three methods via ultrasound in dysphagic stroke patients and test the performance of ultrasound compared to videofluoroscopy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• stroke diagnosis
• aged 18-75
• dysphagia assessed by bedside examination (phase 1: wet voice or cough after drinking 5 ml clear water is positive, phase 2: if phase 1 is negative, inability of drinking 60 ml of water in 2 minutes without coughing or wet voice is positive)

Exclusion Criteria:

• unable to consent due cognitive dysfunction
• unable to cooperate with videofluoroscopic study
• dysphagia before stroke
• rheumatologic or neuromuscular disorder that may cause dysphagia

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Oropharyngeal
• Stroke

Intervention

Diagnostic Test:
• Ultrasonographic study
Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.
• Videofluoroscopic study temporal parameters
Glossopalatine junction opening and closing time, velopharyngeal junction opening and closing time, laryngeal vestibule opening and closing time, upper esophageal sphincter opening and closing time in seconds.
• Videofluoroscopic study distance parameters
Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.

Locations

Country	Name	City	State
Turkey	Bezmialem University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Hsiao MY, Chang YC, Chen WS, Chang HY, Wang TG. Application of ultrasonography in assessing oropharyngeal dysphagia in stroke patients. Ultrasound Med Biol. 2012 Sep;38(9):1522-8. doi: 10.1016/j.ultrasmedbio.2012.04.017. Epub 2012 Jun 12. — View Citation

Huang YL, Hsieh SF, Chang YC, Chen HC, Wang TG. Ultrasonographic evaluation of hyoid-larynx approximation in dysphagic stroke patients. Ultrasound Med Biol. 2009 Jul;35(7):1103-8. doi: 10.1016/j.ultrasmedbio.2009.02.006. Epub 2009 May 7. — View Citation

Martino R, Foley N, Bhogal S, Diamant N, Speechley M, Teasell R. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke. 2005 Dec;36(12):2756-63. doi: 10.1161/01.STR.0000190056.76543.eb. Epub 2005 Nov 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glossopalatine junction opening and closing time	Opening and closing time of glossopalatine junction after swallowing via videofluoroscopy in seconds.	through study completion, an average of 1 year
Primary	Velopharyngeal junction opening and closing time	Opening and closing time of velopharyngeal junction after swallowing via videofluoroscopy in seconds.	through study completion, an average of 1 year
Primary	Laryngeal vestibule opening and closing time	Opening and closing time of laryngeal vestibule after swallowing via videofluoroscopy in seconds.	through study completion, an average of 1 year
Primary	Upper esophageal sphincter opening and closing time	Opening and closing time of upper esophageal sphincter after swallowing via videofluoroscopy in seconds.	through study completion, an average of 1 year
Primary	Hyoid horizontal replacement	Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.	through study completion, an average of 1 year
Primary	Hyoid vertical replacement	Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.	through study completion, an average of 1 year
Primary	Thyroid-hyoid approximation	Difference of distance between thyroid cartilage and hyoid bone in rest and swallowing in centimeters via ultrasonography.	through study completion, an average of 1 year
Primary	Tongue thickness	Tongue thickness in cm assessed in rest submentally.	through study completion, an average of 1 year
Primary	Hyoid anterior replacement	Distance of hyoid bone replacement between rest position and swallowing in centimeters via ultrasonography.	through study completion, an average of 1 year