Sedation Effects in Mechanically Ventilated Patients

描述（由申请人提供）：在成人和儿童重症监护环境中，对机械通气患者进行镇静治疗的需求是明确的。在重症监护环境镇静的总体目标是提供生理稳定，呼吸机同步和患者舒适。在危重成人和儿童中使用不适当的高或低剂量镇静会带来重大风险。镇静管理是一个多学科的过程，但在94%的icu中，护士主要负责镇静给药和滴定的决策。护士根据广泛的非系统信息调整镇静，这可能导致镇静不足或过度。如果不清楚目前使用的镇静治疗是否能成功实现所有镇静目标，就不可能设计出优化镇静评估和管理的方法。因此，本前瞻性研究的具体目的是确定镇静对实现人群机械通气患者镇静目标（生理稳定性、呼吸机同步性和舒适性）的影响。第二个目的是确定受试者和影响镇静目标实现的镇静因素。共有200名受试者（年龄在2岁及以上），来自1名儿科icu和3名成人icu，将在2年的时间内入组。每个受试者将被监测24小时以确定是否达到镇静目标。使用患者状态指数持续测量镇静水平。生理稳定性将通过持续的HR， SpO2， RR和心率变异性来测量。呼吸机同步性将通过持续气道压力和观察同步性来测量。舒适度将通过连续的手腕活动仪和面部和前额鬼脸的连续肌电图来测量。所有数据将由研究小组成员收集并下载到计算机中进行分析。将对所有变量进行描述性统计。24小时内的自然历史将使用每个测量的时间图来描述，确定每个受试者在24小时内达到镇静目标的时间量。然后将为主要结果和次要结果开发重复测量逻辑回归模型，并将同时考虑主要结果测量开发单一多变量模型。

DESCRIPTION (provided by applicant): 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.