Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

Completed

• Conditions: Dysphagia; Swallowing Disorder

• Registration Number: NCT03598491
• Lead Sponsor: Ulsan University Hospital

Brief 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.

Study Timeline

• Study Start: 2015-09-18
• Primary Completion: 2017-11-17
• Study Completion: 2017-12-31
• Study First Submitted: 2018-07-13
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-26
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 755

Inclusion Criteria

• All the patients who referred for video-fluoroscopic-swallowing study

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Laryngeal protection	within 1 hour after video-fluoroscopic-swallowing study	Penetration aspiration scale (zero to eight)

Secondary Outcome Measures

Name	Time	Method
Oral feeding	within 1 week before video-fluoroscopic-swallowing study	Success of Oral feeding after video-fluoroscopic-swallowing study or not

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of