Aspiration in Acute Respiratory Failure Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 855
- 试验地点
- 10
- 主要终点
- Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies
研究概览
简要总结
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe.
详细描述
The purpose of this study is to learn more about problems with swallowing that could develop in patients who are very sick and need a machine to help them breathe. Patients are asked to be in this study because they had problems breathing on their own and therefore needed the help of a machine called a ventilator. In order for this ventilator to push air into the lungs, patients need a tube placed in the throat called an endotracheal tube. The process of placing this endotracheal tube was called intubation. The tube has now been removed, which is a process called extubation. Sometimes, people who have had endotracheal tubes can have difficulty swallowing food and liquids for a period of time. This disease is called post-extubation dysphagia (PED). PED is a serious condition and may result in food or liquid going from the mouth into the lungs. This could cause further lung problems. Given this risk, doctors sometimes suggest that patients with PED either avoid eating or drinking, or get a feeding tube. Currently, nobody knows how often patients develop PED, why they develop it, or the best method to detect it. Standard care involves clinicians making educated guesses. This study looks to determine if watching the patient swallow, both with and without a small camera, is an accurate method for detecting PED.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Admission to an ICU.
- •Mechanical ventilation with an endotracheal tube for greater than 48 hours.
排除标准
- •Likely persistent contraindications to enteral/oral nutrition administration.
- •Pre-existing history of dysphagia or aspiration.
- •Pre-existing or acute primary central or peripheral neuromuscular disorder.
- •Presence of a chronic tracheostomy (present prior to ICU admission).
- •Pre-existing head and neck cancer or surgery.
- •Coagulopathy resulting in uncontrolled nasal or pharyngeal bleeding.
- •Delirium for more than 96 hours after extubation as assessed by Confusion Assessment Method (CAM-ICU).
- •Extubated for greater than 96 hours.
- •Inability to obtain informed consent from patient or an appropriate surrogate.
- •Age < 18 years.
结局指标
主要结局
Percentage of participants experiencing aspiration on the FEES with any of the feeding consistencies
时间窗: from extubation day 1 through hospital discharge, expected to be within 28 days
Aspiration (PAS score of ≥6) on the FEES with any of the feeding consistencies. A PAS score of ≥ 6 includes patients with both silent and non-silent aspiration. Using a PAS cutoff score of ≥6 on FEES, patients will be stratified by aspiration on any of the five consistencies.
次要结局
- Percentage of participants experiencing non-silent aspiration(from extubation day 1 through hospital discharge, expected to be within 28 days)
- Duration required for liberation from mechanical ventilation(from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average)
- Percentage of participants experiencing silent aspiration(from extubation day 1 through hospital discharge, expected to be within 28 days)
- Percentage of participants experiencing post-extubation clinical laryngeal edema(Within 24 hours after extubation)
- Duration of mechanical ventilation(from intubation and receipt of mechanical ventilation through extubation, expected to be within 2-14 days on average)