Sedation Effects in Mechanically Ventilated Patients

成人和儿科重症监护环境中机械通气患者对镇静治疗的需求 是公认的。在重症监护环境中镇静的总体目标是提供生理性的 稳定性、呼吸机同步性和患者舒适度。使用不适当的高或低水平的镇静剂， 重症成人和儿童伴随着重大风险。镇静管理是一种 多学科的过程，但在94%的ICU，护士主要负责决策， 给药和镇静滴定。护士根据广泛的非系统性 可能导致镇静不足或过度的信息。如果不清楚地了解 无论目前使用的镇静疗法是否成功地达到了所有的镇静目的， 设计优化镇静评估和管理的方法。因此，这一具体目标 前瞻性研究是确定镇静在达到镇静目标（生理稳定性， 呼吸机同步性和舒适性）。第二个目标是 确定影响镇静目标实现的受试者和镇静因素。共200名受试者 (ages 2岁及以上）将在2年内从1个儿科ICU和3个成人ICU入组。每个 受试者将被监测24小时以确定镇静目标的实现。镇静剂的浓度 使用患者状态指数连续测量。生理稳定性将通过连续测量 HR、SpO2、RR和心率变异性。将通过连续气道测量呼吸机同步性 压力和观察到的同步。将使用连续腕关节活动记录仪测量舒适度， 面部和前额做鬼脸的连续肌电图。所有数据将由研究团队成员收集， 下载到电脑上进行分析将对所有变量进行描述性统计。自然 将使用每个测量的时间图描述24小时期间的历史， 在24个周期内，每个受试者达到镇静目标的时间量。重复测量 然后将为主要和次要结局开发逻辑回归模型， 将开发多变量模型，同时考虑主要结局指标。

The need for sedative therapy in mechanically ventilated patients in adult and pediatric critical care settings is well established. The overall goals of sedation in the critical care setting are to provide physiologic stability, ventilator synchrony and patient comfort. The use of inappropriately high or low levels of sedation in critically ill adults and children is accompanied by significant risks. Sedation management is a multidisciplinary process but in 94% of ICUs, nurses are primarily responsible for decision-making about administration and titration of sedation. Nurses adjust sedation based on a wide range of non-systematic information which may result in either inadequate or excessive sedation. Without a clear understanding of whether present use of sedative therapy is successful in achieving all sedation goals, it is not possible to devise methods to optimize the evaluation and management of sedation. Therefore the specific aim of this prospective study is to determine the effect of sedation in achieving sedation goals (physiologic stability, ventilator synchrony and comfort) in mechanically ventilated patients across populations. A secondary aim is to identify subject and sedative factors that affect achievement of sedation goals. A total of 200 subjects (ages 2 years and older) from one pediatric and 3 adult ICUs will be enrolled over a 2 year period. Each subject will be monitored for 24 hours to determine achievement of sedation goals. Sedation level will be measured continuously using the Patient State Index. Physiologic stability will be measured by continuous HR, SpO2, RR and heart rate variability. Ventilator synchrony will be measured by continuous airway pressure and observed synchrony. Comfort will be measured using continuous wrist actigraphy and continuous EMG of facial and forehead grimacing. All data will be collected by research team members and downloaded to a computer for analysis. Descriptive statistics of all variables will be performed. The natural history over the 24-hour period will be described using time plots for each of the measurements, identifying amount of time in a 24 period that sedation goals have been achieved for each subject. Repeated-measures logistic regression models will then be developed for primary as well as secondary outcomes and a single multivariable model will be developed with the primary outcome measures considered simultaneously.