Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing
NCT ID: NCT02822456
Last Updated: 2019-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2015-12-31
2020-12-31
Brief Summary
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Detailed Description
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Both traditional IOE tube and individual 3D printed guiding tube groups will receive training about procedure prior to the first feeding. All participants will be evaluated with satisfaction for tube feeding (EORTC QLQ-H\&N35) in 3 days from the start day of the tube feeding. On the day of oral feeding, participants will be evaluated with the questionnaires and clinical examination. If the participant is discharged in a state maintain the tube feeding, investigated further length stay at leaving the hospital. On the 1 month, 3 month from tube feeding, the investigators will follow-up and measure the questionnaires and clinical examination.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Individual 3D-printed guided tube
IOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat
VFSS
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
traditional IOE tube
classic IOE tube feeding using nelaton tube only whenever they eat
VFSS
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
nasogastric tube
nasogastric tube feeding using levin tube always
VFSS
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
Interventions
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VFSS
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
Eligibility Criteria
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Inclusion Criteria
* Patients participating in the study agreement
* Oral feeding is not possible (Need tube feeding)
Exclusion Criteria
* Crico-pharyngeal incoordination
* Impaired esophageal peristalsis
* Impaired GI tract
* Observed esophageal reflux
ALL
No
Sponsors
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Ulsan University Hospital
OTHER
Responsible Party
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Chang Ho Hwang
Associate Professor
Principal Investigators
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Chang Ho Hwang, M.D., Ph.D.
Role: STUDY_DIRECTOR
Ulsan University Hospital
Locations
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Ulsan University Hospital
Ulsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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chhwang5
Identifier Type: -
Identifier Source: org_study_id
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