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

Ulsan University Hospital

Status: Unknown

Conditions: Dysphagia

Treatments: Procedure: VFSS

Study type: Interventional

Funder types: Other

Identifiers

NCT02822456

chhwang5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Individual 3D-printed guided tube

Experimental group

Description:

IOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat

Treatment:

Procedure: VFSS

traditional IOE tube

Active Comparator group

Description:

classic IOE tube feeding using nelaton tube only whenever they eat

Treatment:

Procedure: VFSS

nasogastric tube

Active Comparator group

Description:

nasogastric tube feeding using levin tube always

Treatment:

Procedure: VFSS