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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 755

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 682-714
    • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the inpatients and outpatients who referred for video-fluoroscopic-swallowing study

Description

Inclusion Criteria:

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

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Laryngeal protection	Penetration aspiration scale (zero to eight)	within 1 hour after video-fluoroscopic-swallowing study

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral feeding	Success of Oral feeding after video-fluoroscopic-swallowing study or not	within 1 week before video-fluoroscopic-swallowing study

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheostomy	Presence of tracheostomy or not	within 1 day before video-fluoroscopic-swallowing study
Allergic reaction	Contrast allergic reaction to the Iohexl	within 2 days before video-fluoroscopic-swallowing study
Symptoms of chemical pneumonitis	Radiological alteration on a chest xray	within 1 week before video-fluoroscopic-swallowing study
Hospital stay	Total days from admission to discharge	within 1 day after discharge
Days to discharge	Total Days from video-fluoroscopic-swallowing study to discharge	within 1 day after discharge

Collaborators and Investigators

• Sponsor: Ulsan University Hospital
• Investigators: Study Director: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2015
• Primary Completion (Actual): November 17, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: July 13, 2018
• First Submitted That Met QC Criteria: July 13, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: chhwang10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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