NCT03598491

Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 755 (actual)
• Sponsor: Ulsan University Hospital · Academic / Other
• Sex: All
• Age: 3 Years
• Healthy volunteers: Not accepted

Summary

In traditional video-fluoroscopic-swallowing study, a lipid-soluble contrast (barium sulfate) has been used more than 30 years. However, it can cause chemical pneumonitis and subsequently impair reliability of video-fluoroscopic-swallowing study if aspirated. The authors reviewed the safety and usefulness of an water soluble agent-based swallowing test.

Detailed description

Parallel-group, case-controlled trial was conducted from September 2015 to November 2017. All the patients who referred for video-fluoroscopic-swallowing study were screened. Based on the pre-emptive evaluation, high-risky patients were allocated to iohexol (Omnipaque)-used video-fluoroscopic-swallowing study and others were allocated to barium sulfate-used video-fluoroscopic-swallowing study. Statistical Package for the Social Sciences 24 was used to perform statistical analysis for the data. Quantitative data were presented as mean ± standard errors.

Conditions

• Dysphagia
• Swallowing Disorder

Timeline

• Start date: 2015-09-18
• Primary completion: 2017-11-17
• Completion: 2017-12-31
• First posted: 2018-07-26
• Last updated: 2019-09-27

Locations

1 site across 1 country: South Korea