Defining risk for iatrogenic withdrawal syndrome in critically ill children

描述(由申请人提供)：对接受机械通风支持的危重儿科患者的人道护理需要包括镇静治疗在内的舒适度管理。危重患者很快就会对用于镇静治疗的阿片类药物和苯二氮卓类药物产生耐受性，并需要增加这些药物的剂量才能达到同样的治疗效果。反过来，在从原发病中恢复后，耐药患者迅速脱机或突然停止镇静治疗会导致医源性戒断综合征--这一问题增加了重症监护的个人和经济负担。使用一个新的概念模型，将患者、过程和系统水平的风险因素联系起来，这些因素被认为有助于医源性戒断综合征的发展，我们认为有必要从一个新的角度来解决儿科重症监护中这一可预防的并发症。我们建议使用最近完成的RESTORE研究的数据[U01HL086622和U01 HL086649；护士领导的镇静治疗对2448名因急性呼吸衰竭而需要机械呼吸的儿童的临床结果的31中心群组随机试验]进行二次分析，比较那些发生医源性戒断综合征的受试者和没有发生医源性戒断综合征的受试者之间的患者、过程和系统水平的数据。通过探索多个水平的变量，这项研究将是有史以来第一次完成的医源性戒断综合征的全面评估。这项研究将回答一个关键问题：哪些因素影响危重疾病康复中的儿科患者医源性戒断综合征的发展？此外，患者因素、过程因素和系统因素的相对贡献可以结合在一起，为危重疾病康复的儿科患者中临床上有意义的医源性戒断综合征的患者风险创建一个预测统计模型。这项拟议的研究将把医源性戒断综合症现象与其发生的独特临床环境联系起来。这项研究的结果将进一步推动NINR更好地了解症状管理和疾病原因，包括促进个性化干预发展的系统(如家庭单位、人口和/或组织)的行为的使命。

DESCRIPTION (provided by applicant): Humane care for critically ill pediatric patients supported on mechanical ventilation necessitates comfort management that includes sedation therapy. Critically ill patients quickly become tolerant to the opioids and benzodiazepines used for sedation therapy and require increasing doses of these medications to achieve the same therapeutic effect. In turn, after recovery from their primary illnesses, rapid weaning or abrupt cessation of sedative therapy in drug tolerant patients precipitates iatrogenic withdrawal syndrome - a problem that adds to the personal and financial burden of intensive care. Using a novel conceptual model relating patient-, process- and system-level risk factors that are thought to contribute to the development of iatrogenic withdrawal syndrome, we believe a new perspective for addressing this preventable complication of pediatric intensive care is warranted. We propose to use data from the recently completed RESTORE study [U01HL086622 and U01 HL086649; 31-center cluster randomized trial of nurse- led sedation management on clinical outcomes in 2448 children requiring mechanical ventilation for acute respiratory failure] to conduct a secondary analysis comparing patient-, process- and system-level data between those subjects who developed iatrogenic withdrawal syndrome and those who did not. By exploring variables at several levels, this study will be the first comprehensive evaluation of iatrogenic withdrawal syndrome ever completed. The study will answer the key question: What factors impact the development of iatrogenic withdrawal syndrome in pediatric patients recovering from critical illness? Furthermore, the relative contributions of patient, process, and systems factors can be combined to create a predictive statistical model of patient risk for clinically significant iatrogenic withdrawal syndrome in pediatric patients recovering from critica illness. The proposed study will contextualize the phenomenon of iatrogenic withdrawal syndrome within the unique clinical circumstances in which it occurs. The results of this study will further NINR's mission to better understand symptom management and the causes of disease, including the behavior of systems (e.g. family units, populations, and/or organizations) that promote the development of personalized interventions.