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

Dysphagia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02822456
• Other study ID #: chhwang5
• Status: Recruiting
• Phase: N/A
• Start date: December 2015
• Est. completion date: December 2020

Study information

• Verified date: December 2019
• Source: Ulsan University Hospital
• Contact: Chang Ho Hwang
• Phone: +82-52-250-8898
• Email: chhwang1220ciba[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Procedure:
• VFSS
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (1)

Lead Sponsor	Collaborator
Ulsan University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	change Mid-arm circumference		before VFSS and 1 month and 3 months after start of tube feeding
Secondary	change of Serum albumin		before VFSS and 1 month and 3 months after start of tube feeding
Secondary	change of MRS index		before VFSS and 1 month and 3 months after start of tube feeding
Secondary	change of success rate (rate of elimination)		after 1st session (3days), after 1 month, and after 3 months
Secondary	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