Comparison Between Ultrasonographic and Nasofibroscopic Evaluation in Extubated Patients With Dysphagia in the Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Diagnostic Concordance (Kappa Index).
研究概览
简要总结
The goal of this observational study is to evaluate the diagnostic performance and concordance of bedside cervical ultrasonography compared to Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the early detection of post-extubation dysphagia in critically ill adult patients.
The main questions it aims to answer are:
- What is the degree of diagnostic concordance (Kappa index) between cervical ultrasonography and nasofibroscopy (FEES) for detecting dysphagia in the Intensive Care Unit (ICU)?
- What are the sensitivity, specificity, and predictive values of ultrasonography as a non-invasive screening tool compared to the gold standard (FEES)?
- Are there specific cut-off points for ultrasonographic parameters (such as hyoid bone displacement and laryngeal elevation) that accurately identify patients at risk of aspiration? Methodology and Comparison: Researchers will evaluate a cohort of patients who have undergone mechanical ventilation for more than 48 hours. The study compares the findings of cervical ultrasonography (an accessible and non-invasive bedside method) with FEES (the clinical gold standard) to determine the feasibility of ultrasound as an initial screening tool in the ICU setting. Participant Tasks: Participants will undergo the following procedures within 24 to 48 hours post-extubation: A bedside cervical ultrasonography to measure swallowing-related anatomical movements, such as hyoid displacement and laryngeal elevation. A nasofibroscopy (FEES) performed by trained personnel to directly visualize the pharyngeal and laryngeal structures during swallowing. A clinical evaluation of cranial nerve function and monitoring for respiratory complications like bronchoaspiration or pneumonia.
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
- •Critically ill patients admitted to the Intensive Care Unit (ICU).
- •Patients aged 18 years or older.
- •Patients who have required orotracheal intubation and mechanical ventilation for a period exceeding 48 hours.
- •Patients successfully liberated from mechanical ventilation (post-extubation phase).
- •Obtainment of signed Informed Consent from the patient or their legal representative.
排除标准
- •Patients with a known prior history of oropharyngeal dysphagia, esophageal disorders, or structural abnormalities of the upper airway.
- •Patients with pre-existing neurological diseases that compromise the swallowing reflex (e.g., advanced Parkinson's disease, previous stroke with residual dysphagia, Amyotrophic Lateral Sclerosis).
- •Patients with a history of head and neck surgery or radiotherapy.
- •Patients with a Glasgow Coma Scale (GCS) score < 13 at the time of evaluation.
- •Patients with hemodynamic instability or severe respiratory distress that precludes the diagnostic procedures.
- •Anatomical limitations that prevent the correct placement of the ultrasound transducer or the introduction of the nasofibroscope (e.g., severe facial trauma, nasal obstruction).
- •Medical contraindication for Fiberoptic Endoscopic Evaluation of Swallowing (FEES).
结局指标
主要结局
Diagnostic Concordance (Kappa Index).
时间窗: At 48 hours post-extubation.
The degree of diagnostic agreement between bedside cervical ultrasonography and Fiberoptic Endoscopic Evaluation of Swallowing (FEES) for the detection of post-extubation dysphagia. This will be evaluated using Cohen's Kappa coefficient to determine if ultrasonography is a reliable alternative to the gold standard.
次要结局
- Diagnostic Sensitivity and Specificity.(At 48 hours post-extubation.)
- Ultrasonographic Parameter Cut-off Points.(At 48 hours post-extubation.)
- Incidence of Respiratory Complications.(From ICU admission through ICU discharge, up to 30 days)
研究者
Jose J Zaragoza, MD MSc
Principal Investigator
Hospital H+ Queretaro
