Screen and Intervene: A Diagnostic Accuracy Study and A Randomized, Open-label, Controlled Trial for Postextubation Dysphagia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Incidence of penetration and aspiration
研究概览
简要总结
This clinical trial aims to test the validity of a two-item swallowing screen and to examine the effects of the Swallowing and Oral-Care (SOC) Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.
详细描述
Endotracheal intubation is life-sustaining, but it may contribute to postextubation dysphagia (PED) increasing the risk of penetration, aspiration, and aspiration pneumonia. Up to 84% of extubated patients had PED and approximately 60% penetrated and aspirated that can lead to aspiration pneumonia. The aims of this three-year, two-stage study are: 1) In the first stage, the investigators develop a two-item swallowing screen involving oral stereognosis and cough reflex test for predicting the resumption of oral intake and feeding-tube dependence by using a diagnostic accuracy study method; 2) In the second stage, the investigators conduct a randomized, open-label, controlled trial design to examine the effect of a once-daily, 7-day SOC Program on resumption of oral intake, incidence of penetration and aspiration, and incidence of pneumonia in adult patients who successfully extubated after ≥ 48 hours of endotracheal intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
To maintain allocation concealment, the investigators ensured that only the intervention nurse had access to the random sequence. Physicians and staff at the study sites were aware of a pending nursing-intervention study but were blinded with respect to the hypothesis, group allocation, specific SOC protocols, and study endpoints. Moreover, outcome assessors were blinded to the group assignments, ensuring an unbiased evaluation.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient who is over 20 years old.
- •Patient how has received over 48 hours endotracheal intubation and had been successfully extubated.
排除标准
- •Patient who has a history of neuromuscular disease (e.g., parkinsonism or stroke) or head and neck deformities.
- •Patient who has preexisting difficulty swallowing.
- •Patient who has received a tracheostomy.
- •Patient who were unable to follow verbal instructions.
- •Patient who were on contact and droplet precautions (e.g., open tuberculosis)
- •Patient who were receiving continuous noninvasive ventilation after extubation that precluded the delivery of an SOC intervention
结局指标
主要结局
Incidence of penetration and aspiration
时间窗: Time points of assessments: within 48 hrs postextubation and at the day 10 postextubation
Measured by the Fiberoptic endoscopic evaluation of swallowing (FEES) with optional and the study participants either opt-in or opt-out for this procedure, given that its invasive-nature procedure.
Resumption of oral feeding
时间窗: Postextubation 7 days
Measured by Functional Oral Intake Scale
Incidence of pneumonia
时间窗: Postextubation 30 days
Abstracted from electronic medical records, based on the American Thoracic Society/Infectious Diseases Society of America criteria.
次要结局
- Oral health status score(Time points of assessments: within 48 hours postextubation and at the day 10 postextubation)
- Incidence of feeding tube dependency(Postextubation 30 days)
- Unstimulated salivary flow rate (centimeter/5 minutes)(Time points of assessments: within 48 hours postextubation and at the day 10 postextubation)
- Lip closure and lingual diadochokinetic status(Time points of assessments: within 48 hours postextubation and at the day 10 postextubation)