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

Not Applicable

• Conditions: Dysphagia
• Interventions: Procedure: VFSS

• Registration Number: NCT02822456
• Lead Sponsor: Ulsan University Hospital

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-06-14
• Study First Submitted QC: 2016-06-29
• Study First Posted: 2016-07-04
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-02
• Last Update Posted: 2019-12-03
• Primary Completion: 2020-12
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Individual 3D-printed guided tube	VFSS	IOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat
nasogastric tube	VFSS	nasogastric tube feeding using levin tube always
traditional IOE tube	VFSS	classic IOE tube feeding using nelaton tube only whenever they eat

Primary Outcome Measures

Name	Time	Method
change of EORTC QLQ - H&N35 index	1 month after start of tube feeding	Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10)

Secondary Outcome Measures

Name	Time	Method
complications	after 1st session (3days) and after 1 month, and after 3 months	whether aspiration pneumonia on Chest Radiography or not, Measurement at leave hospital or start oral feeding can be another endpoint
change of Serum albumin	before VFSS and 1 month and 3 months after start of tube feeding
change of EORTC QLQ - H&N35 index	after 1st session (3days) and after 3 months	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)
change Mid-arm circumference	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

Trial Locations

Locations (1)

Ulsan University Hospital; 🇰🇷 Ulsan, Korea, Republic of