Sedation Effects in Mechanically Ventilated Patients

描述(由申请人提供)：在成人和儿科重症监护环境中对机械通气患者进行镇静治疗的必要性得到了充分的证实。重症监护环境中镇静的总体目标是提供生理稳定性、呼吸机同步性和患者舒适性。在危重成人和儿童中使用不适当的高水平或低水平的镇静伴随着重大风险。镇静管理是一个多学科的过程，但在94%的ICU中，护士主要负责镇静药物的给药和滴定决策。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疗法是否成功地实现了所有镇静目标，就不可能设计出优化镇静评估和管理的方法。因此，这项前瞻性研究的具体目的是确定镇静在不同人群中实现镇静目标(生理稳定性、呼吸机同步性和舒适性)的效果。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。来自1个儿科ICU和3个成人ICU的200名受试者(2岁及以上)将在2年内登记。每个受试者都将接受24小时的监测，以确定镇静目标的实现情况。镇静程度将使用患者状态指数进行持续测量。生理稳定性将通过持续的HR、SpO2、RR和心率变异性来衡量。呼吸机的同步性将通过持续的气道压力和观察到的同步性来衡量。舒适度将使用连续的腕部动作图和面部和前额的连续肌电图来衡量。所有数据将由研究团队成员收集并下载到计算机进行分析。将对所有变量进行描述性统计。24小时内的自然病史将使用每次测量的时间图来描述，确定在24小时内每个受试者达到镇静目标的时间量。然后将为主要和次要结果开发重复测量Logistic回归模型，并将开发同时考虑主要结果测量的单一多变量模型。

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.