임상연구정보서비스

Search: Search

Compliance and complications with viscosity modified-diet in dysphagia patients

Status Approved

First Submitted Date

2021/03/23
Registered Date

2021/04/09
Last Updated Date

2021/03/23

Move list page

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0006076
Unique Protocol ID	2019-0518
Public/Brief Title	Compliance and complications with viscosity modified-diet in dysphagia patients
Scientific Title	Compliance and complications with viscosity modified-diet in dysphagia patients
Acronym	CCVMDDP
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	2019-0518
Approval Date	2019-04-18
Institutional Review Board Name	Asan Medical Center Institutional Review Board
Institutional Review Board Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul
Institutional Review Board Telephone	02-3010-7166
Data Monitoring Committee	No

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	Min Ho Chun
Title	MD, PhD
Telephone	+82-2-3010-3796
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
Contact Person for Public Queries
Name	Hyejoon Ahn
Title	MD
Telephone	+82-2-3010-0679
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea
Contact Person for Updating Information
Name	Hyejoon Ahn
Title	MD
Telephone	+82-2-3010-0679
Affiliation	Asan Medical Center
Address	88, Olympic-ro 43-gil, Songpa-gu, Seoul, Republic of Korea

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Active, not recruiting
Date of First Enrollment	2019-07-20 Actual
Target Number of Participant	20
Primary Completion Date	2021-12-31 , Anticipated
Study Completion Date	2021-12-31 , Anticipated
Name of Study	Asan Medical Center
Recruitment Status	Active, not recruiting
Date of First Enrollment	2019-07-20 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Asan Medical Center
Organization Type	Medical Institute
Project ID	2019-0518

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Asan Medical Center
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	1. Objective To investigate the viscosity of thickened fluids ingested by dysphagia patients with brain lesion and the incidence of adverse effects based on fluid viscosity. 2. Hypothesis There is no significant difference in the incidence of complications according to the viscosity of the liquid actually consumed by patients with dysphagia brain lesions. 3. Background Previous studies on whether the use of thickeners reduces the incidence of pneumonia are controversial. However, there are no studies that measured the viscosity of thickened liquids ingested by patients. Therefore, no studies have evaluated the correlation between pneumonia incidence and the viscosity of thickened liquids ingested by patients. The purpose of this study was to investigate the viscosity of the thickened fluids consumed by dysphagia patients with brain lesion and to evaluate the incidence of adverse events according to the viscosity of these liquids. 4. Method This was a prospective observational study at a single site. We enrolled 20 dysphagia patients with brain lesion who were recommended to use thickeners following the videofluoroscopic swallowing study. Patients were educated to drink thickened fluid of level 2 or 3 based on the International Dysphagia Diet Standardization Initiative (IDDSI) flow test. We evaluated the viscosity of the fluid that patients drank once a week for 2 weeks, and reviewed medical records regarding adverse effects. Patients were divided into two groups based on the average value obtained from viscosity evaluations. Adverse events were compared between the groups, including pneumonia, urinary tract infection (UTI), constipation, and dehydration status.

Study Summary Information

Lay Summary

1. Objective
To investigate the viscosity of thickened fluids ingested by dysphagia patients with brain lesion and the incidence of adverse effects based on fluid viscosity.

2. Hypothesis
There is no significant difference in the incidence of complications according to the viscosity of the liquid actually consumed by patients with dysphagia brain lesions.

3. Background
Previous studies on whether the use of thickeners reduces the incidence of pneumonia are controversial. However, there are no studies that measured the viscosity of thickened liquids ingested by patients. Therefore, no studies have evaluated the correlation between pneumonia incidence and the viscosity of thickened liquids ingested by patients.
The purpose of this study was to investigate the viscosity of the thickened fluids consumed by dysphagia patients with brain lesion and to evaluate the incidence of adverse events according to the viscosity of these liquids.

4. Method
This was a prospective observational study at a single site. We enrolled 20 dysphagia patients with brain lesion who were recommended to use thickeners following the videofluoroscopic swallowing study. Patients were educated to drink thickened fluid of level 2 or 3 based on the International Dysphagia Diet Standardization Initiative (IDDSI) flow test. We evaluated the viscosity of the fluid that patients drank once a week for 2 weeks, and reviewed medical records regarding adverse effects. Patients were divided into two groups based on the average value obtained from viscosity evaluations. Adverse events were compared between the groups, including pneumonia, urinary tract infection (UTI), constipation, and dehydration status.

8. Study Design

Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
Study Type	Observational Study
Observational Study Model	Others
Time Perspective	Prospective
Target Number of Participant	20
Cohort/Group Number	2
Cohort/ Group 1	Cohort/Group Label Thin fluid group
Cohort/ Group 1	Cohort/Group Description The patients were divided into the following two groups based on the average value of two viscosity evaluations : a thin fluid group (IDDSI level 0-2) and a thick fluid group (IDDSI level 3-4).
Cohort/ Group 2	Cohort/Group Label Thick fluid group
Cohort/ Group 2	Cohort/Group Description The patients were divided into the following two groups based on the average value of two viscosity evaluations : a thin fluid group (IDDSI level 0-2) and a thick fluid group (IDDSI level 3-4).
Biospecimen Collection & Archiving	Not collect nor Archive
Biospecimen Description

9. Subject Eligibility

Subject Eligibility Information
Study Population Description	Dysphagia patients with brain lesion
Sampling Method	This study was a simple observational study and did not use sampling method.
Condition(s)/Problem(s)	* (R00-R99)Symptoms, signs and abnormal clinical and laboratory findings, NEC (R13)Dysphagia Humans, Dysphagia, Viscosity, Prospective studies
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 19Year~No Limit
	Description (a) 진단시 19세 이상; (b) 허혈성 뇌졸중, 출혈성 뇌졸중, 외상성 뇌손상, 그리고 뇌종양으로 진단 받은 환자; (c) 비디오 투시연하검사 상 thin fluid 에서 PAS 점수가 2점 이상이고; (d) 비디오 투시연하검사상 점도증진제 사용을 추천 받은 환자
Exclusion Criteria	(a) 두경부암 병력이 있는 자; (b) 심각한 인지저하가 있는 자; (c) Oral thrush 또는 active oral infection이 있는 자; (d) 진행성 또는 감염성 신경질환을 진단 받은 자; (e) 내과적인 질환으로 수분공급을 제한하는 자; (f) 심각한 호흡기질환의 과거력이 있는 자; (g) 최근 4주내에 폐렴을 진단 받은 자
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Not applicable
Outcome	the viscosity of the fluid ingested by the patients
Timepoint	once a week for 2 weeks
Secondary Outcome(s) 1
Outcome	incidence of adverse effects according to fluid viscosity
Timepoint	at discharge

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

Move list page Move to top