Post Critical Illness Dysphagia in the Intensive Care Unit (Dysphagia-ICU): a Single Centre Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Dysphagia
研究概览
简要总结
The aims of the study are to determine: 1) the prevalence of ICU acquired dysphagia, 2) identify risk factors for ICU Acquired dysphagia, and 3) consequences of ICU acquired dysphagia including: ICU mortality, hospital mortality, days of mechanical ventilation, ICU length of stay, hospital length of stay, post extubation aspiration pneumonia, and rate of percutaneous endoscopic gastrostomy placed feeding tube (PEG-Tube) insertion, and/or total parenteral nutrition (TPN) and/or Dobhoff feeds.
详细描述
The RC will collect daily data on the use of advance life support, need for mechanical ventilation and outcomes (mortality, duration of mechanical ventilation, ICU length of stay, hospital length of stay). Enrolled patients will undergo a water sip test in the ICU and a videofluroscopic swallowing study (VFSS) performed by a registered speech-language pathologist (SLP). A VFSS is a videotaped or digitized dynamic fluoroscopic image that focuses on the oral, pharyngeal, laryngeal and upper esophageal swallow physiology. Patients will then be followed as two cohorts 1) patients that have dysphagia (or abnormal test) based on the VFSS, and 2) patients who have normal VFSS. We will then prospectively follow these two groups of patients during hospital stay censored at 30 days.
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
- •Adults (18 years of age and older)
- •Received mechanically ventilated for > 24 hours
- •Have been extubated for >24 hours
- •Hemodynamically stable (i.e. not requiring active resuscitation or vasoactive agents)
- •Able to participate in VFSS - with n the first 7 days after successful extubation. (+/- 2 days)
排除标准
- •Gastrostomy tube or a Gastro-jejunostomy tubes
- •Current contraindication to oral feeding (eg. recent gastrointestinal surgeries as indicated by their surgeons)
- •Being actively palliated
- •Tracheostomy
- •Neuromuscular condition associated with dysphagia: (e.g., amyotrophic lateral sclerosis, myasthenia gravis)
- •Pre-existing history of dysphagia
- •Ongoing respiratory support (defined as requiring ≥ 50% oxygen, bi-level positive airway pressure, or high flow nasal cannula) for 7 days or more after extubation.
- •Caring physician declined
结局指标
主要结局
Dysphagia
时间窗: Hospital Discharge or 30 days post VFSS
Defined as -abnormal VFSS scores resulting in need for modification of oral diet textures or non-oral means of nutrition and hydration provision.
次要结局
- PEG tube insertion or need for TPF or Dobhoff feeds(Hospital Discharge or 30 days post VFSS)
- Aspiration(Hospital Discharge or 30 days post VFSS)
- Pneumonia(Hospital Discharge or 30 days post VFSS)
- Length of Stay(Hospital Discharge or 30 days post VFSS)
- Mortality(Hospital Discharge or 30 days post VFSS)
- Reintubation(Hospital Discharge or 30 days post VFSS)
研究者
Waleed Al-Hazzani
Dr. Waleed Alhazzani
St. Joseph's Healthcare Hamilton