Feasibility of a Water-soluble Contrast Application Into... | NCT03598491

Studies
Feasibility of a Water-soluble Contrast Application Into Dysphagia Evaluation

NCT03598491

Sponsor

Ulsan University Hospital

Status

Completed

Last Update Posted

Sep 27, 2019Actual

Enrollment

755Actual

Phase

Not provided

Conditions

Dysphagia
Swallowing Disorder

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2015Actual

Primary Completion Date

Nov 17, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Jul 13, 2018

First Submission Date that Met QC Criteria

Jul 13, 2018

First Posted Date

Jul 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2019

Last Update Posted Date

Sep 27, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chang Ho Hwang, Associated Professor, PhD and MD, Ulsan University HospitalPrincipal Investigator

Lead Sponsor

Ulsan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

755Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Iohexol		Iohexol was applied in video-fluoroscopic-swallowing study
Barium		Barium was applied in video-fluoroscopic-swallowing study

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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 Outcomes

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

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Chang Ho Hwang, M.D., Ph.D.	Ulsan University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ulsan University Hospital		Ulsan		682-714	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
35801762	Derived	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.

ID	Term
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D010608	Pharyngeal Diseases