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

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

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.

Study Overview

• Status: Unknown
• Conditions: Dysphagia
• Intervention / Treatment: Procedure: VFSS

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ulsan, Korea, Republic of, 682-714
    • Recruiting
    • Ulsan University Hospital
    • Contact: Chang Ho Hwang, M.D., Ph.D.; Phone Number: +82-52-250-7210; Email: chhwang1220ciba@gmail.com
    • Principal Investigator: Chang Ho Hwang, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ulsan University Hospital
• Investigators: Study Director: Chang Ho Hwang, M.D., Ph.D., Ulsan University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 14, 2016
• First Submitted That Met QC Criteria: June 29, 2016
• First Posted (Estimate): July 4, 2016

Study Record Updates

• Last Update Posted (Actual): December 3, 2019
• Last Update Submitted That Met QC Criteria: December 2, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: dysphagia; intermittent tube; individual 3D printed guiding tube
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Esophageal Diseases; Deglutition Disorders
• Other Study ID Numbers: chhwang5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No