Sedation Management in Pediatric Patients with Acute Respiratory Failure

产品描述：（申请人提供）：确保接受机械通气支持的危重婴儿或儿童的安全性和舒适性是儿科重症监护实践的组成部分。人道儿科重症监护往往包括镇静管理。虽然在无法理解重症监护仪器和固定的必要性的儿科患者中使用镇静剂有明显的益处，但镇静剂的使用与医源性损伤相关。具体而言，用于镇静的药物可能会抑制自主通气并延长机械通气的持续时间。随着时间的推移，药物耐受性的发展，并可能沉淀医源性戒断综合征时，不再需要镇静。延长机械通气时间和医源性戒断综合征增加了重症监护的个人和经济负担。这项随机临床试验将测试一种创新的镇静管理方法，包括：[a]在接受机械通气支持的儿科患者中使用镇静剂的团队教育和共识，[B]团队确定患者的疾病轨迹和镇静目标的每日处方，[c]护士实施的目标导向舒适算法，指导阿片类药物和苯二氮卓类药物的即时滴定，[d]团队对镇静管理性能的反馈。干预是针对所有PICU临床医生的组织变革。随机化的单位是PICU，推断的单位是患者，我们将控制中心效应。18个儿科重症监护室（9个随机分配至镇静管理干预，9个继续提供常规护理）将入组2754名接受机械通气支持的危重婴儿和儿童。我们认为，根据镇静方案管理的患者将经历更少的机械通气天数，更少的镇静剂暴露，更少的医源性戒断症状，更短的重症监护住院时间，更少的费用，并经历更好的出院后生活质量和情绪健康。

Description: (provided by applicant): Ensuring the safety and comfort of critically ill infants or children supported on mechanical ventilation is integral to the practice of pediatric critical care. Humane pediatric intensive care often includes sedation management. Although there are clear benefits in using sedation in pediatric patients who are unable to understand the imperative nature of critical care instrumentation and immobility, sedative use is associated with iatrogenic injury. Specifically, the medications used for sedation may depress spontaneous ventilation and prolong the duration of mechanical ventilation. Over time, drug tolerance develops and may precipitate iatrogenic withdrawal syndrome when sedation is no longer necessary. Prolonging the duration of mechanical ventilation and iatrogenic withdrawal syndrome add to the personal and financial burden of intensive care. This cluster randomized clinical trial will test an innovative approach to sedation management that includes: [a] team education and consensus on the use of sedatives in pediatric patients supported on mechanical ventilation, [b] team identification of the patient's trajectory of illness and daily prescription of a sedation goal, [c] a Nurse-Implemented Goal-Directed Comfort Algorithm that guides moment-to-moment titration of opioids and benzodiazepines, and [d] team feedback on sedation management performance. The intervention is an organizational change directed at all PICU clinicians. The unit of randomization is the PICU, the unit of inference is the patient, and we will control for center effects. Eighteen pediatric intensive care units (9 randomized to the sedation management intervention and 9 to continue to provide usual care) will enroll 2754 critically-ill infants and children supported on mechanical ventilation. We believe that patients managed per sedation protocol will experience fewer days of mechanical ventilation, less sedative exposure, fewer iatrogenic withdrawal symptoms, a shorter intensive care length of stay, less costs, and experience a better post-discharge quality of life and emotional health.