Sedation Management in Pediatric Patients with Acute Respiratory Failure

描述：(申请人提供)：确保危重婴儿或接受机械通风支持的儿童的安全和舒适是儿科危重护理实践不可或缺的一部分。人性化的儿科重症监护通常包括镇静治疗。尽管对于不能理解重症监护器械的必要性和不能动弹的儿科患者使用镇静剂有明显的好处，但镇静剂的使用与医源性损伤有关。具体地说，用于镇静的药物可能会抑制自发通气量，延长机械通气期。随着时间的推移，药物耐受性的发展，并可能导致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停药综合症增加了重症监护的个人和经济负担。这项群组随机临床试验将测试一种创新的镇静管理方法，其中包括：[a)团队教育和对接受机械通气支持的儿科患者使用镇静剂的共识，[b)团队确定患者的病情轨迹和每日镇静目标处方，[c]护士实施的目标导向舒适算法，该算法指导阿片类药物和苯二氮卓类药物的即时滴定，以及[d]团队对镇静管理绩效的反馈。这项干预是针对所有PICU临床医生的组织变革。随机单位是PICU，推理单位是患者，我们将控制中心效应。18个儿科重症监护病房(9个随机接受镇静管理干预，9个继续提供常规护理)将招收2754名接受机械通气支持的危重婴儿和儿童。我们相信，按照镇静方案管理的患者将经历更少的机械通气天数，更少的镇静药物暴露，更少的医源性戒断症状，更短的重症监护住院时间，更低的费用，并体验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.