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Completed

NCT Number: NCT04344392

Screening of Dysphagia Via Ultrasonography in Patients With Stroke

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.

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Key information

Conditions

Dysphagia, Oropharyngeal Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Hemiplegia Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Paralysis Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Signs and Symptoms Stroke Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bezmialem University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasonographic study

Diagnostic Test

Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.

Videofluoroscopic study temporal parameters

Diagnostic Test

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

Diagnostic Test

Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.

Primary outcomes

  1. Glossopalatine junction opening and closing time

    Time frame: through study completion, an average of 1 year

    Opening and closing time of glossopalatine junction after swallowing via videofluoroscopy in seconds.

  2. Velopharyngeal junction opening and closing time

    Time frame: through study completion, an average of 1 year

    Opening and closing time of velopharyngeal junction after swallowing via videofluoroscopy in seconds.

  3. Laryngeal vestibule opening and closing time

    Time frame: through study completion, an average of 1 year

    Opening and closing time of laryngeal vestibule after swallowing via videofluoroscopy in seconds.

  4. Upper esophageal sphincter opening and closing time

    Time frame: through study completion, an average of 1 year

    Opening and closing time of upper esophageal sphincter after swallowing via videofluoroscopy in seconds.

  5. Hyoid horizontal replacement

    Time frame: through study completion, an average of 1 year

    Maximal horizontal replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.

  6. Hyoid vertical replacement

    Time frame: through study completion, an average of 1 year

    Maximal vertical replacement of hyoid bone during swallowing via videofluoroscopy in centimeters.

  7. Thyroid-hyoid approximation

    Time frame: through study completion, an average of 1 year

    Difference of distance between thyroid cartilage and hyoid bone in rest and swallowing in centimeters via ultrasonography.

  8. Tongue thickness

    Time frame: through study completion, an average of 1 year

    Tongue thickness in cm assessed in rest submentally.

  9. Hyoid anterior replacement

    Time frame: through study completion, an average of 1 year

    Distance of hyoid bone replacement between rest position and swallowing in centimeters via ultrasonography.

Sponsors and collaborators

Lead sponsor

Bezmialem Vakif University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 14, 2020
Registry last updated
Mar 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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