Clinical trial NCT02822456: Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing
Official title: Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing: Prospective, Single Center, Observational Trial of Superiority
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dysphagia
Keywords: dysphagia
intermittent tube
individual 3D printed guiding tube
Lead sponsor: Ulsan University Hospital
Sponsor class: OTHER
First posted: 2016-07-04
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: change of EORTC QLQ - H&N35 index
timeFrame: 1 month after start of tube feeding
Secondary outcomes:
measure: complications
timeFrame: after 1st session (3days) and after 1 month, and after 3 months
measure: change Mid-arm circumference
timeFrame: before VFSS and 1 month and 3 months after start of tube feeding
measure: change of Serum albumin
timeFrame: before VFSS and 1 month and 3 months after start of tube feeding
measure: change of MRS index
timeFrame: before VFSS and 1 month and 3 months after start of tube feeding
measure: change of success rate (rate of elimination)
timeFrame: after 1st session (3days), after 1 month, and after 3 months
measure: change of EORTC QLQ - H&N35 index
timeFrame: after 1st session (3days) and after 3 months
Other outcomes:
Locations:
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
Study officials:
affiliation: Ulsan University Hospital
name: Chang Ho Hwang, M.D., Ph.D.
role: STUDY_DIRECTOR
References: