A Study of the Differences Between Submental Ultrasonography (SUS) and Assessment by Speech-Language Pathologists (SLP) for Nasogastric Tube Removal
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal
研究概览
简要总结
This randomized controlled trial aims to compare the assessment accuracy between submental ultrasound (SUS) and speech-language pathologists (SLP) for nasogastric tube removal in post-acute dysphagia adult patients. The primary question is whether the assessment accuracy of submental ultrasound (SUS) is equivalent to or better than that of speech-language pathologists (SLP).
Participants will undergo both submental ultrasound (SUS) and speech-language pathologists (SLP) assessments and will be randomly assigned to either the SUS group or the SLP group for further evaluation.
The SUS group will follow an oral feeding and tube removal training protocol based on submental ultrasound criteria for swallowing function (maximum hyoid bone displacement ≥ 1.38 cm). The SLP group will follow similar training protocols based on the speech-language pathologist's clinical assessment.
Researchers will compare outcomes such as nasogastric tube removal rate, vital signs, basic laboratory data, hyoid bone displacement on ultrasound, choking and aspiration rates, success rates of training protocols, and Functional Oral Intake Scale (FOIS) scores to determine if SUS is a reliable assessment method for swallowing function and NG tube removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 and above
- •Patients using a nasogastric tube
- •Patients with a nasogastric tube placed due to acute conditions, such as increased oxygen demand, temporary loss of consciousness, or other illnesses causing weakness and a risk of aspiration. After treatment, there is no longer any indication for continued nasogastric tube placement.
排除标准
- •Patients with impaired consciousness
- •Patients with long-term nasogastric tube placement
- •Patients requiring a high-concentration oxygen mask or mechanical ventilation with intubation
- •Patients with significant drooling or frequent aspiration of saliva
- •Patients who have undergone oral or head and neck surgery
- •Patients who have received radiation therapy for the head and neck
研究组 & 干预措施
SUS group
The SUS group follows an oral feeding diet and tube removal training protocol based on submental ultrasound criteria, with a maximum hyoid bone displacement of ≥ 1.38 cm as an indicator of swallowing function.
干预措施: Submental ultrasound criteria (Diagnostic Test)
SLP group
The SLP group follows an oral feeding diet and tube removal training protocol based on the speech-language pathologist's assessment of swallowing function, which includes evaluating sensory and motor functions of the oral and facial muscles, phonation, swallowing motion, and other relevant factors.
干预措施: Routine swallowing function assessment of speech-language pathologist (Diagnostic Test)
结局指标
主要结局
Comparing the assessment accuracy between submental ultrasound and speech therapist on nasogastric tube removal
时间窗: From enrollment to the end of treatment at 8 weeks
Rate of nasogastric tube removal Rate of successful completion of the tube removal training protocol
次要结局
- Comparing the differences in ultrasound images between the submental ultrasound group and the speech therapist group(From enrollment to the end of treatment at 8 weeks)
- Comparing the rate of aspiration pneumonia between the submental ultrasound group and the speech therapist group(From enrollment to the end of treatment at 8 weeks)