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

Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing: Prospective, Single Center, Observational Trial of Superiority

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.

VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube

Details (inconvenience, discomfort, altered body image, social activities, family life, pain, ease of learning to use) satisfaction evaluation (3, 9, 10)

whether aspiration pneumonia on Chest Radiography or not, Measurement at leave hospital or start oral feeding can be another endpoint

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)

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