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OpenTrials
Completed

NCT Number: NCT03598491

Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

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.

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Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases Swallowing Disorder

Age range

3 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ulsan University Hospital

Ulsan, 682-714, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • none

Treatment and study plan

Primary outcomes

  1. Laryngeal protection

    Time frame: within 1 hour after video-fluoroscopic-swallowing study

    Penetration aspiration scale (zero to eight)

Secondary outcomes

  1. Oral feeding

    Time frame: within 1 week before video-fluoroscopic-swallowing study

    Success of Oral feeding after video-fluoroscopic-swallowing study or not

Other outcomes

  1. Tracheostomy

    Time frame: within 1 day before video-fluoroscopic-swallowing study

    Presence of tracheostomy or not

  2. Allergic reaction

    Time frame: within 2 days before video-fluoroscopic-swallowing study

    Contrast allergic reaction to the Iohexl

  3. Symptoms of chemical pneumonitis

    Time frame: within 1 week before video-fluoroscopic-swallowing study

    Radiological alteration on a chest xray

  4. Hospital stay

    Time frame: within 1 day after discharge

    Total days from admission to discharge

  5. Days to discharge

    Time frame: within 1 day after discharge

    Total Days from video-fluoroscopic-swallowing study to discharge

Sponsors and collaborators

Lead sponsor

Ulsan University Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 26, 2018
Registry last updated
Sep 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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