Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

NCT ID: NCT03598491

Last Updated: 2019-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

755 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-18

Study Completion Date

2017-12-31

Brief Summary

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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

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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

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Dysphagia Swallowing Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Iohexol

Iohexol was applied in video-fluoroscopic-swallowing study

No interventions assigned to this group

Barium

Barium was applied in video-fluoroscopic-swallowing study

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* none
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Ho Hwang

Associated Professor, PhD and MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang Ho Hwang, M.D., Ph.D.

Role: STUDY_DIRECTOR

Ulsan University Hospital

Locations

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Ulsan University Hospital

Ulsan, , South Korea

Site Status

Countries

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South Korea

References

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Hwang CH. Swallowing study using water-soluble contrast agents may increase aspiration sensitivity and antedate oral feeding without respiratory and drug complications: A STROBE-compliant prospective, observational, case-control trial. Medicine (Baltimore). 2022 Jul 8;101(27):e29422. doi: 10.1097/MD.0000000000029422.

Reference Type DERIVED
PMID: 35801762 (View on PubMed)

Other Identifiers

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chhwang10

Identifier Type: -

Identifier Source: org_study_id

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