Incidence, Risk Factors, and Outcomes of Silent Aspiration Post Extubation in the ICU
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 274
- 试验地点
- 1
研究概览
简要总结
Post-extubation dysphagia is common in critically ill patients and may lead to silent aspiration, which often remains undetected because patients do not exhibit overt clinical signs such as coughing or choking. Current bedside nursing swallow screening may fail to identify silent aspiration in patients recovering from prolonged mechanical ventilation.
The goal of this observational study is to learn about the incidence, risk factors, and clinical outcomes of silent aspiration in critically ill adult patients who require prolonged mechanical ventilation and are extubated in the ICU. The main questions it aims to answer are:
- How often does silent aspiration occur in ICU patients intubated for 5 days or longer after extubation?
- Can silent aspiration be present despite passing the routine bedside nursing swallow screen?
- What clinical factors are associated with silent aspiration?
- Is silent aspiration associated with worse clinical outcomes such as aspiration pneumonia, reintubation, prolonged ICU stay, ventilator-free days, or mortality? Participants who have been mechanically ventilated for 5 days or more will undergo routine bedside swallow screening followed by Fiberoptic Endoscopic Evaluation of Swallowing (FEES), considered the gold-standard diagnostic tool for detecting silent aspiration, within 72 hours after extubation. Researchers will compare bedside nursing swallow screening results with FEES findings to evaluate the diagnostic accuracy of bedside screening in detecting silent aspiration. Clinical data, swallowing assessment findings, and patient outcomes will also be collected and analyzed.
详细描述
Background:
Post-extubation dysphagia (PED) is common in critically ill patients and is often multifactorial in origin, resulting from trauma, neuromuscular weakness, altered sensation, impaired cognition, and desynchronized breathing-swallowing coordination. Silent aspiration - defined as entry of oropharyngeal material below the vocal folds without overt clinical signs such as coughing or choking - has been reported in up to 69.3% of ICU patients undergoing instrumental assessment. Despite this, current clinical practice at many centers does not mandate instrumental swallow evaluation for patients who pass routine bedside nursing swallow screening.
Study Design:
This is a prospective observational study conducted in the ICU at Cleveland Clinic Abu Dhabi (CCAD). Informed consent will be obtained from all patients or their next of kin prior to enrollment.
Participants:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult ICU patients requiring invasive mechanical ventilation for 5 days or longer
- •Successful extubation after invasive mechanical ventilation
- •Undergoing bedside nursing swallow screening after extubation
- •Ability to undergo Fiberoptic Endoscopic Evaluation of Swallowing (FEES) within 72 hours after extubation
- •Provision of informed consent by the patient or legally authorized representative
排除标准
- •Presence of tracheostomy
- •Do-not-reintubate orders/Allow natural death
- •Pregnancy
- •Absence of informed consent
- •Contraindication to FEES as determined by the treating physician (e.g., high bleeding risk or severe oxygen requirements)
研究者
Jihad Mallat
Critical Care Consultant
Cleveland Clinic Abu Dhabi