Effectivity of Early Recovery Accelerated Swallowing Program on Promoting Swallowing Recovery in Older Patients With High Risk of Oral Frailty Requiring Endotracheal Intubation During General Anesthesia: a Pilot Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- UES pressure, mmHg
研究概览
简要总结
The investigators studied that swallowing function of patients receiving the Early Recovery Accelerated Swallowing (ERAS-W program) training will recover fast than that of patients in the control group. The ERAS program training will be initiated before surgery and continue to after surgery.
详细描述
The older patients (≥65 years old) with OFI-8≥4 undergoing elective orthopedic surgery requiring tracheal intubation will be recruited. Patients will be randomized into an intervention and a control group. Patients in the intervention groups will received the ERAS-W program, while those in the control group will receive the swallowing education video.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Data manager knows whether the patients are in the intervention or control group. However, the patients, caregiver, investigator, and outcome assessors do not know whether the patients are in the intervention or control group.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery
- •general anesthesia with endotracheal intubation
排除标准
- •major organ dysfunction, ex: chronic kidney disease, hear failure
- •bleeding tendency
结局指标
主要结局
UES pressure, mmHg
时间窗: about six months
次要结局
未报告次要终点
研究者
National Taiwan University Clinical Trial Center
Principal Investigator
National Taiwan University Hospital