Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

Dysphagia Clinical Trial

Official title:

Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03598491
• Other study ID #: chhwang10
• Status: Completed
• Start date: September 18, 2015
• Est. completion date: December 31, 2017

Study information

• Verified date: September 2019
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 755
• Est. completion date: December 31, 2017
• Est. primary completion date: November 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• none

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Swallowing Disorder

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Tracheostomy	Presence of tracheostomy or not	within 1 day before video-fluoroscopic-swallowing study
Other	Allergic reaction	Contrast allergic reaction to the Iohexl	within 2 days before video-fluoroscopic-swallowing study
Other	Symptoms of chemical pneumonitis	Radiological alteration on a chest xray	within 1 week before video-fluoroscopic-swallowing study
Other	Hospital stay	Total days from admission to discharge	within 1 day after discharge
Other	Days to discharge	Total Days from video-fluoroscopic-swallowing study to discharge	within 1 day after discharge
Primary	Laryngeal protection	Penetration aspiration scale (zero to eight)	within 1 hour after video-fluoroscopic-swallowing study
Secondary	Oral feeding	Success of Oral feeding after video-fluoroscopic-swallowing study or not	within 1 week before video-fluoroscopic-swallowing study