Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation
1 other identifier
observational
755
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFirst Submitted
Initial submission to the registry
July 13, 2018
CompletedFirst Posted
Study publicly available on registry
July 26, 2018
CompletedSeptember 27, 2019
September 1, 2019
2.2 years
July 13, 2018
September 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Laryngeal protection
Penetration aspiration scale (zero to eight)
within 1 hour after video-fluoroscopic-swallowing study
Secondary Outcomes (1)
Oral feeding
within 1 week before video-fluoroscopic-swallowing study
Other Outcomes (5)
Tracheostomy
within 1 day before video-fluoroscopic-swallowing study
Allergic reaction
within 2 days before video-fluoroscopic-swallowing study
Symptoms of chemical pneumonitis
within 1 week before video-fluoroscopic-swallowing study
- +2 more other outcomes
Study Arms (2)
Iohexol
Iohexol was applied in video-fluoroscopic-swallowing study
Barium
Barium was applied in video-fluoroscopic-swallowing study
Eligibility Criteria
All the inpatients and outpatients who referred for video-fluoroscopic-swallowing study
You may qualify if:
- All the patients who referred for video-fluoroscopic-swallowing study
You may not qualify if:
- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ulsan University Hospital
Ulsan, 682-714, South Korea
Related Publications (1)
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.
PMID: 35801762DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chang Ho Hwang, M.D., Ph.D.
Ulsan University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associated Professor, PhD and MD
Study Record Dates
First Submitted
July 13, 2018
First Posted
July 26, 2018
Study Start
September 18, 2015
Primary Completion
November 17, 2017
Study Completion
December 31, 2017
Last Updated
September 27, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share