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

NCT ID: NCT02822456

Last Updated: 2019-12-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2020-12-31

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.

Conditions

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Dysphagia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type EXPERIMENTAL

VFSS

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

VFSS

Intervention Type PROCEDURE

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

Group Type ACTIVE_COMPARATOR

VFSS

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ulsan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Chang Ho Hwang

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Chang Ho Hwang

Role: CONTACT

+82-52-250-8898

Facility Contacts

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Chang Ho Hwang, M.D., Ph.D.

Role: primary

+82-52-250-7210

Other Identifiers

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chhwang5

Identifier Type: -

Identifier Source: org_study_id

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