Impact of Early Percutaneous Tracheostomy on the Incidence of Swallowing Dysfunction in Critically Ill Patients on Mechanical Ventilation. A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of swallowing dysfunction
研究概览
简要总结
The aim of the study is to determine if performing an early tracheostomy (within the first 4 days of endotracheal intubation) in critically ill patients on mechanical ventilation, reduces the incidence of swallowing dysfunction.
详细描述
The development of initial resuscitation maneuvers, associated with a better knowledge of the physiopathology of critical illnesses and the technological development experienced by critical care medicine, allow us to give vital support to patients for long periods of time. In this scenario, a considerable proportion of critically ill patients may require translaryngeal intubation and invasive mechanical ventilation. Patients who require prolonged translaryngeal intubation have a high risk of developing swallowing dysfunction, a condition predisposing to secretions aspiration. Until now, there has been no demonstration of a causal association between the duration of translaryngeal intubation and development of swallowing dysfunction. However, all the studies about this topic have been performed on patients submitted to prolonged translaryngeal intubation. Clinical studies have documented the development of early laryngotracheal lesions after intubation, which might explain post extubation dysfunction of swallowing reflex, probably as consequence of alteration of mechanic and chemo-receptors of the pharyngeal and laryngeal mucosa. There are no studies evaluating the impact of an early percutaneous tracheostomy on the incidence of swallowing dysfunction in critical care patients. The investigators have documented a 38% of swallowing dysfunction in our critically ill patients submitted to prolonged mechanical ventilation. The hypothesis of the study is that performance of an early percutaneous tracheostomy, within the first 4 days of translaryngeal intubation, in critical care patients on mechanical ventilation, reduces the incidence of swallowing dysfunction. The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) by a trained otolaryngologist, 3 to 5 days after weaning of mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
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
- •Written informed consent has been obtained for the procedure
- •Patients whose need of mechanical ventilation is estimated in ≥ 7 days and require a percutaneous tracheostomy
排除标准
- •Patients younger than 18 years old
- •Patients with neurologic pathology
- •Patients with dysphagia history
- •Patients whose MV duration is estimated in < 7 days
- •Patients with airway obstruction requiring an emergency tracheostomy
- •Patients already having a tracheostomy in situ
- •Pregnancy
- •Patients who have already been enrolled on another trial
- •Patients with absolute contraindication to perform a percutaneous tracheostomy
- •Patients with high risk of dying, life expectancy of < 48 hours
- •Patients in whom limitation of therapy has been decided
- •Family rejection to participate in the study
结局指标
主要结局
Incidence of swallowing dysfunction
时间窗: 3 to 5 days after weaning of mechanical ventilation
The diagnosis of swallowing dysfunction will be performed by fiberoptic endoscopic evaluation of swallowing (FEES) 3 to 5 days after weaning of mechanical ventilation.
次要结局
- All cause mortality(90 days)
- Delirium-free and coma-free days(28 days)
- Daily dose of sedatives(28 days)
- ICU-free days(28 days)
- Critical Care Unit-free days(90 days)
- Hospital length of stay(90 days)
- Ventilator-free days(28 days)
- Incidence of ventilator-associated pneumonia(28 days)