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
|Condition or disease|
|Dysphagia Swallowing Disorder|
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.
|Study Type :||Observational|
|Actual Enrollment :||755 participants|
|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|
Iohexol was applied in video-fluoroscopic-swallowing study
Barium was applied in video-fluoroscopic-swallowing study
- Laryngeal protection [ Time Frame: within 1 hour after video-fluoroscopic-swallowing study ]Penetration aspiration scale (zero to eight)
- Oral feeding [ Time Frame: within 1 week before video-fluoroscopic-swallowing study ]Success of Oral feeding after video-fluoroscopic-swallowing study or not
- Tracheostomy [ Time Frame: within 1 day before video-fluoroscopic-swallowing study ]Presence of tracheostomy or not
- Allergic reaction [ Time Frame: within 2 days before video-fluoroscopic-swallowing study ]Contrast allergic reaction to the Iohexl
- Symptoms of chemical pneumonitis [ Time Frame: within 1 week before video-fluoroscopic-swallowing study ]Radiological alteration on a chest xray
- Hospital stay [ Time Frame: within 1 day after discharge ]Total days from admission to discharge
- Days to discharge [ Time Frame: within 1 day after discharge ]Total Days from video-fluoroscopic-swallowing study to discharge
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
|Korea, Republic of|
|Ulsan University Hospital|
|Ulsan, Korea, Republic of, 682-714|
|Study Director:||Chang Ho Hwang, M.D., Ph.D.||Ulsan University Hospital|