Intermittent Oro-Esophageal Tube Feeding Using Individually-Customized 3-Dimensional Printing: Prospective, Single Center, Observational Trial of Superiority
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- change of EORTC QLQ - H&N35 index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dysphagia patients to check in VFSS (videofluoroscopic swallow study)
- •Patients participating in the study agreement
- •Oral feeding is not possible (Need tube feeding)
排除标准
- •Patient to reject the participation
- •Crico-pharyngeal incoordination
- •Impaired esophageal peristalsis
- •Impaired GI tract
- •Observed esophageal reflux
结局指标
主要结局
change of EORTC QLQ - H&N35 index
时间窗: 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)
次要结局
- 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)
- change of EORTC QLQ - H&N35 index(after 1st session (3days) and after 3 months)
- change Mid-arm circumference(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)
研究者
Chang Ho Hwang
Associate Professor
Ulsan University Hospital