Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing

Study Overview
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Brief Summary
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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.

Detailed Description
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According to standard Guideine of videofluoroscopic swallow study(VFSS), Patients referred to dysphagia(swallowing dysfunction)who were required to tube feeding and medically stable of vital sign, and agreed to participate. Participants with swallowing dysfunction who were classified into three groups (nasogastric tube, traditional intermittent (IOE) tube, individual 3D printed guiding tube) according to VFSS. 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.

Official Title
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Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing: Prospective, Single Center, Observational Trial of Superiority

Conditions
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Dysphagia

Intervention / Treatment
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* Procedure: VFSS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dysphagia patients to check in VFSS (videofluoroscopic swallow study) Patients participating in the study agreement Oral feeding is not possible (Need tube feeding) Exclusion Criteria: Patient to reject the participation Crico-pharyngeal incoordination Impaired esophageal peristalsis Impaired GI tract Observed esophageal reflux
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individual 3D-printed guided tube<br>IOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat | Procedure: VFSS<br>* VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube<br>|
| Active Comparator: traditional IOE tube<br>classic IOE tube feeding using nelaton tube only whenever they eat | Procedure: VFSS<br>* VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube<br>|
| Active Comparator: nasogastric tube<br>nasogastric tube feeding using levin tube always | Procedure: VFSS<br>* VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | whether aspiration pneumonia on Chest Radiography or not, Measurement at leave hospital or start oral feeding can be another endpoint | 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 | 
| change of EORTC QLQ - H&N35 index | Measurement at leave hospital or start oral feeding can be another endpoint, Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10) | after 1st session (3days) and after 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dysphagia, intermittent tube, individual 3D printed guiding tube