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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individual 3D-printed guided tube | Experimental | IOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat |
|
| traditional IOE tube | Active Comparator | classic IOE tube feeding using nelaton tube only whenever they eat |
|
| nasogastric tube | Active Comparator | nasogastric tube feeding using levin tube always |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VFSS | Procedure | VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| change Mid-arm circumference |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Ho Hwang | Contact | +82-52-250-8898 | chhwang1220ciba@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Chang Ho Hwang, M.D., Ph.D. | Ulsan University Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ulsan University Hospital | Recruiting | Ulsan | 682-714 | South Korea |
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| ID | Term |
|---|---|
| D003680 | Deglutition Disorders |
| ID | Term |
|---|---|
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010608 | Pharyngeal Diseases |
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| 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 |
| change of MRS index | before VFSS and 1 month and 3 months after start of tube feeding |
| 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 | 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 |
| D010038 | Otorhinolaryngologic Diseases |