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Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03598491
Enrollment
755
Registered
2018-07-26
Start date
2015-09-18
Completion date
2017-12-31
Last updated
2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dysphagia, Swallowing Disorder

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.

Interventions

None listed

Sponsors

Ulsan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Laryngeal protectionwithin 1 hour after video-fluoroscopic-swallowing studyPenetration aspiration scale (zero to eight)

Secondary

MeasureTime frameDescription
Oral feedingwithin 1 week before video-fluoroscopic-swallowing studySuccess of Oral feeding after video-fluoroscopic-swallowing study or not

Other

MeasureTime frameDescription
Symptoms of chemical pneumonitiswithin 1 week before video-fluoroscopic-swallowing studyRadiological alteration on a chest xray
Tracheostomywithin 1 day before video-fluoroscopic-swallowing studyPresence of tracheostomy or not
Days to dischargewithin 1 day after dischargeTotal Days from video-fluoroscopic-swallowing study to discharge
Hospital staywithin 1 day after dischargeTotal days from admission to discharge
Allergic reactionwithin 2 days before video-fluoroscopic-swallowing studyContrast allergic reaction to the Iohexl

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026