Intensive Care Medicine Department, School of Medicine, Pontificia Universidad Católica de Chile, Santiago, Chile.
School of Nursing, Pontificia Universidad Católica de Chile, Santiago, Chile.
PLoS One. 2023 May 25;18(5):e0286180. doi: 10.1371/journal.pone.0286180. eCollection 2023.
In critically ill patients, sleep and circadian rhythms are greatly altered. These disturbances have been associated with adverse consequences, including increased mortality. Factors associated with the ICU environment, such as exposure to inadequate light and noise levels during the day and night or inflexible schedules of daily care activities, have been described as playing an essential role in sleep disturbances. The main objective of this study is to evaluate the impact of the use of a multifaceted environmental control intervention in the ICU on the quantity and quality of sleep, delirium, and post-intensive care neuropsychological impairment in critically ill patients.
This is a prospective, parallel-group, randomized trial in 56 critically ill patients once they are starting to recover from their acute illness. Patients will be randomized to receive a multifaceted intervention of environmental control in the ICU (dynamic light therapy, auditory masking, and rationalization of ICU nocturnal patient care activities) or standard care. The protocol will be applied from enrollment until ICU discharge. Baseline parameters, light and noise levels, polysomnography and actigraphy, daily oscillation of plasma concentrations of Melatonin and Cortisol, and questionnaires for the qualitative evaluation of sleep, will be assessed during the study. In addition, all patients will undergo standardized follow-up before hospital discharge and at 6 months to evaluate neuropsychological impairment.
This study is the first randomized clinical trial in critically ill patients to evaluate the effect of a multicomponent, non-pharmacological environmental control intervention on sleep improvement in ICU patients. The results will provide data about the potential synergistic effects of a combined multi-component environmental intervention in ICU on outcomes in the ICU and long term, and the mechanism of action.
ClinicalTrials.gov, NCT. Registered on January 10, 2023. Last updated on 24 Jan 2023.
在危重症患者中，睡眠和昼夜节律会发生很大的改变。这些紊乱与不良后果有关，包括死亡率增加。与 ICU 环境相关的因素，如白天和夜间光照和噪声水平不足，或日常护理活动时间表不灵活，被认为在睡眠紊乱中起重要作用。本研究的主要目的是评估 ICU 中使用多方面环境控制干预对危重症患者睡眠量和质量、谵妄和重症监护后神经心理障碍的影响。
这是一项前瞻性、平行组、随机临床试验，纳入 56 名从急性疾病中开始恢复的危重症患者。患者将被随机分配接受 ICU 环境控制的多方面干预（动态光照疗法、听觉掩蔽和 ICU 夜间患者护理活动的合理化）或标准护理。方案将从入组开始实施，直到 ICU 出院。将在研究期间评估基线参数、光照和噪声水平、多导睡眠图和活动记录仪、褪黑素和皮质醇的血浆浓度日波动，以及睡眠质量的定性评估问卷。此外，所有患者将在出院前和 6 个月进行标准化随访，以评估神经心理障碍。
这是第一项在危重症患者中评估多成分非药物环境控制干预对 ICU 患者睡眠改善影响的随机临床试验。研究结果将提供有关 ICU 中联合多成分环境干预对 ICU 内和长期结果的潜在协同作用以及作用机制的数据。
ClinicalTrials.gov，NCT。于 2023 年 1 月 10 日注册。于 2023 年 1 月 24 日更新。
