Evaluation of efficacy and safety of Visipaque in videofluoroscopic swallowing study

JRCT ID: jRCTs061240040

Registered date:26/07/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dysphagia
• Date of first enrollment: 26/07/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

After obtaining informed consent for this study, enrollment will be made, and videofluoroscopic swallowing study using Visipaque as a contrast agent will be performed. After the examination, an investigation of adverse events will be conducted until one month after the examination is performed. Taste evaluation of Visipaque will be performed at the end of the examination. The visibility of the
Visipaque and Barytester (previous examinations) images will be evaluated on the images taken, respectively.

Outcome(s)

• Primary Outcome: Visibility of videofluoroscopic swallowing study images

Secondary Outcome

Adverse effects
Gastrointestinal: diarrhea, nausea, vomiting, abdominal pain, abdominal discomfort, dyspepsia, anal pain
and bleeding, constipation, renal failure, Gastrointestinal perforation, intestinal obstruction, peritonitis
Hypersensitivity: itching, urticaria, rash, erythema, fever, shock, anaphylaxis
Respiratory: aspiration pneumonia, pulmonary edema
Others: ventricular fibrillation, seizure
Taste evaluation
Aspiration
Evaluation of image density

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who has previously undergone the videofluoroscopic swallowing study with Barytester at Hiroshima University Hospital
2. Patients with dysphagia who are at least 18 years of age at the time of informed consent
3. Patients with dysphagia who are eligible for an investigation of adverse effects until one month after videofluoroscopic swallowing study
4. Patients with dysphagia who give written informed consent to participate in this study

Exclude criteria

1. Patients with iodine allergy
2. Patients with severe thyroid disease
3. Patients with serious renal disease
4. Patients with bronchial asthma
5. Patients with serious cardiac disorders
6. Patients with macroglobulinemia
7. Patients with multiple myeloma
8. Patients with tetany
9. Patients with or suspected of having pheochromocytoma
10. Patients with bronchial asthma, rash, urticaria, or other allergic reactions in themselves, their parents, or their siblings
11. Patients with a history of drug hypersensitivity
12. Patients with dehydration
13. Patients with hypertension
14. Patients with arteriosclerosis
15. Patients with diabetes mellitus
16. Patients with acute pancreatitis
17. Patients with biliary tract infection
18. Patients with severe hepatic disorder
19. Patients with a history of gastrointestinal tract disease or surgery
20. Women who are pregnant or may become pregnant, women who are breastfeeding, or women who wish to have a baby
21. Patients who are participating or intend to participate in other clinical studies while participating in this study
22. If participation in the research would not be in the best interest of the research subject or would interfere with evaluation
specific to the clinical research protocol
23. Any principal investigator or other employee of the institution who is directly involved in this or other clinical research, or any
family member of such an employee or principal investigator

Related Information

• Primary Sponsor: Konishi Masaru