An interventional study of VFSS in Dysphagia, sponsored by Ulsan University Hospital. Status unknown at 1 site in Korea, Republic of. Per ClinicalTrials.gov, last updated 2019-12-03.
Sponsored by Ulsan University Hospital · Not applicable, Interventional, and Treatment
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.
710 studies on the registry are indexed under Deglutition Disorders; 219 are open to participants now.
This study's planned enrollment of 24 is below the median of 60 across 471 interventional studies indexed under Deglutition Disorders.
Browse Deglutition Disorders studies →Ulsan University Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
IOE tube feeding using individual 3D-printed guided tube and nelaton tube whenever they eat
Procedure: VFSS
classic IOE tube feeding using nelaton tube only whenever they eat
Procedure: VFSS
nasogastric tube feeding using levin tube always
Procedure: VFSS
VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
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)
Time frame: 1 month after start of tube feeding
complications
whether aspiration pneumonia on Chest Radiography or not, Measurement at leave hospital or start oral feeding can be another endpoint
Time frame: after 1st session (3days) and after 1 month, and after 3 months
change Mid-arm circumference
Time frame: before VFSS and 1 month and 3 months after start of tube feeding
change of Serum albumin
Time frame: before VFSS and 1 month and 3 months after start of tube feeding
change of MRS index
Time frame: before VFSS and 1 month and 3 months after start of tube feeding
change of success rate (rate of elimination)
Time frame: 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)
Time frame: after 1st session (3days) and after 3 months
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.
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Ulsan University Hospital