Dysphagia
Conditions
Keywords
dysphagia, intermittent tube, individual 3D printed guiding tube
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.
Interventions
PROCEDUREVFSS
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
Sponsors
Ulsan University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change of EORTC QLQ - H&N35 index | 1 month after start of tube feeding | Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| complications | after 1st session (3days) and after 1 month, and after 3 months | whether aspiration pneumonia on Chest Radiography or not, Measurement at leave hospital or start oral feeding can be another endpoint |
| 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 | after 1st session (3days) and after 3 months | 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) |
| change of MRS index | before VFSS and 1 month and 3 months after start of tube feeding | — |
Countries
South Korea
Contacts
Primary ContactChang Ho Hwang
Outcome results
None listed