Clinical trial: Ultrasound and Videofluoroscopy for Diagnosing Swallowing Disorders (NCT00001220)

Eligibility criteria:
INCLUSION CRITERIA:

        Any Clinical Center inpatients and outpatients with known or suspected dysphagia on any
        other NIH institute protocol can be included for study as well as patients who are admitted
        specifically for this protocol.

        Those patients at risk for oropharyngeal dysfunction will be screened initially by
        completing a self-assessment swallowing questionnaire, and by an interview with staff
        and/or family members. Patients who demonstrate appropriate signs and symptoms of dysphagia
        and oral motor impairment on the screening assessment will be considered for the protocol:

        Difficulty swallowing food or pills.

        Changed swallowing ability.

        Coughing or choking when eating.

        Shortness of breath during swallowing.

        Food backing up into the mouth or nasal passage.

        Fever or voice changes after swallowing.

        Pain when swallowing.

        Unexplained loss of weight.

        EXCLUSION CRITERIA:

        Patients who are severely demented or severely compromised will be excluded if they do not
        have sufficient cognitive ability to follow directions.

        Patients who are non-ambulatory will be excluded if they can not be braced or supported
        within the fluoroscopy unit.

        Highly agitated individuals will also be excluded if they are unable to remain confined in
        the equipment.

        Infants and children under age 3 will be excluded due to radiation risk on the developing
        visual system.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



Patient description (medical language): A 50-year-old woman comes to the clinic complaining of difficulty swallowing both liquids and solid foods, as well as occasional cough while eating.  She also has difficulty lifting her arms above her head and getting up from a chair. The weakness seems to get worse gradually. The patient has no prior medical problems and takes no medications.  Vital signs are normal.  Physical examination shows an erythematous rash on the upper eyelids. There are some red papules over joints of her hands. The rest of the physical examination is unremarkable. Antinuclear antibodies, anti-Jo-1 antibodies and anti-MDA5 antibody are positive.  Muscle biopsy shows perifascicular inflammation and atrophy of the fascicle and surrounding blood vessels.

Patient description (patient's own words): I had to go to the clinic because of difficulty swallowing all kinds of food, liquid and solid. I also sometimes cough when I eat my dinner. At only 50 year old, I had some difficulties lifting up my arms and getting up from a chair! And it's only getting worse! I never had any medical issues in the past and I'm not under any medication, I just don't get it! My vitals were normal. The physical exam showed a red rash on my upper eyelids. I also have red papules on my hands' joints. After a blood test, they told me that my antinuclear antibodies, anti-Jo-1 antibodies, and anti-MDA5 antibodies were positive.  I also did a muscle biopsy and it showed that I had an atrophy of my blood vessels around my muscle fibers and that I have an inflammation of these.

Does the patient match the trial criteria? Entailment