Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing
1 other identifier
interventional
24
1 country
1
Brief Summary
The aim of this study is to test the clinical effectiveness of IOE tube using individually customized 3-dimentional printed guiding tube as an alternative to Levin tube feeding when unconscious patients have no choice but tube feeding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2015
Longer than P75 for not_applicable
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
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
June 14, 2016
CompletedFirst Posted
Study publicly available on registry
July 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedDecember 3, 2019
December 1, 2019
5 years
June 14, 2016
December 2, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change of EORTC QLQ - H&N35 index
Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10)
1 month after start of tube feeding
Secondary Outcomes (6)
complications
after 1st session (3days) and after 1 month, and after 3 months
change Mid-arm circumference
before VFSS and 1 month and 3 months after start of tube feeding
change of Serum albumin
before VFSS and 1 month and 3 months after start of tube feeding
change of MRS index
before VFSS and 1 month and 3 months after start of tube feeding
change of success rate (rate of elimination)
after 1st session (3days), after 1 month, and after 3 months
- +1 more secondary outcomes
Study Arms (3)
Individual 3D-printed guided tube
EXPERIMENTALIOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat
traditional IOE tube
ACTIVE COMPARATORclassic IOE tube feeding using nelaton tube only whenever they eat
nasogastric tube
ACTIVE COMPARATORnasogastric tube feeding using levin tube always
Interventions
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
Eligibility Criteria
You may qualify if:
- Dysphagia patients to check in VFSS (videofluoroscopic swallow study)
- Patients participating in the study agreement
- Oral feeding is not possible (Need tube feeding)
You may not qualify if:
- Patient to reject the participation
- Crico-pharyngeal incoordination
- Impaired esophageal peristalsis
- Impaired GI tract
- Observed esophageal reflux
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ulsan University Hospital
Ulsan, 682-714, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chang Ho Hwang, M.D., Ph.D.
Ulsan University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 14, 2016
First Posted
July 4, 2016
Study Start
December 1, 2015
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
December 3, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share