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Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

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ClinicalTrials.gov Identifier: NCT03598491
Recruitment Status : Completed
First Posted : July 25, 2018
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Ho Hwang, 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.

Condition or disease
Dysphagia Swallowing Disorder

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.


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Study Type : Observational
Actual Enrollment : 755 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation
Actual Study Start Date : September 18, 2015
Actual Primary Completion Date : November 17, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine


Group/Cohort
Iohexol
Iohexol was applied in video-fluoroscopic-swallowing study
Barium
Barium was applied in video-fluoroscopic-swallowing study



Primary Outcome Measures :
  1. Laryngeal protection [ Time Frame: within 1 hour after video-fluoroscopic-swallowing study ]
    Penetration aspiration scale (zero to eight)


Secondary Outcome Measures :
  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 Outcome Measures:
  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



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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All the inpatients and outpatients who referred for video-fluoroscopic-swallowing study
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03598491


Locations
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Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of, 682-714
Sponsors and Collaborators
Ulsan University Hospital
Investigators
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Study Director: Chang Ho Hwang, M.D., Ph.D. Ulsan University Hospital

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Responsible Party: Chang Ho Hwang, Associated Professor, PhD and MD, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT03598491     History of Changes
Other Study ID Numbers: chhwang10
First Posted: July 25, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases