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探究运动加速度计作为一种睡眠监测技术的应用以及重症监护环境对睡眠质量的临床负担:澳大利亚一项前瞻性观察性研究的研究方案。

Investigating the application of motion accelerometers as a sleep monitoring technique and the clinical burden of the intensive care environment on sleep quality: study protocol for a prospective observational study in Australia.

作者信息

Delaney Lori J, Currie Marian J, Huang Hsin-Chia Carol, Litton Edward, Wibrow Bradley, Lopez Violeta, Haren Frank Van

机构信息

Faculty of Nursing, University of Canberra, Canberra, Australia.

College of Health and Medicine; Australian National University, Canberra, Australia.

出版信息

BMJ Open. 2018 Jan 21;8(1):e019704. doi: 10.1136/bmjopen-2017-019704.

Abstract

INTRODUCTION

Sleep is a state of quiescence that facilitates the significant restorative processes that enhance individuals' physiological and psychological well-being. Patients admitted to the intensive care unit (ICU) experience substantial sleep disturbance. Despite the biological importance of sleep, sleep monitoring does not form part of standard clinical care for critically ill patients. There exists an unmet need to assess the feasibility and accuracy of a range of sleep assessment techniques that have the potential to allow widespread implementation of sleep monitoring in the ICU.

KEY MEASURES

The coprimary outcome measures of this study are to: determine the accuracy and feasibility of motion accelerometer monitoring (ie, actigraphy) and subjective assessments of sleep (nursing-based observations and patient self-reports) to the gold standard of sleep monitoring (ie, polysomnography) in evaluating sleep continuity and disturbance. The secondary outcome measures of the study will include: (1) the association between sleep disturbance and environmental factors (eg, noise, light and clinical interactions) and (2) to describe the sleep architecture of intensive care patients.

METHODS AND ANALYSIS

A prospective, single centre observational design with a within subjects' assessment of sleep monitoring techniques. The sample will comprise 80 adults (aged 18 years or more) inclusive of ventilated and non-ventilated patients, admitted to a tertiary ICU with a Richmond Agitation-Sedation Scale score between +2 (agitated) and -3 (moderate sedation) and an anticipated length of stay >24 hours. Patients' sleep quality, total sleep time and sleep fragmentations will be continuously monitored for 24 hours using polysomnography and actigraphy. Behavioural assessments (nursing observations) and patients' self-reports of sleep quality will be assessed during the 24-hour period using the Richards-Campbell Sleep Questionnaire, subjective sleepiness evaluated via the Karolinska Sleepiness Scale, along with a prehospital discharge survey regarding patients' perception of sleep quality and disturbing factors using the Little Sleep Questionnaire will be undertaken. Associations between sleep disturbance, noise and light levels, and the frequency of clinical interactions will also be investigated. Sound and luminance levels will be recorded at 1 s epochs via Extech SDL600 and SDL400 monitoring devices. Clinical interactions will be logged via the electronic patient record system Metavision which documents patient monitoring and clinical care.

ETHICS AND DISSEMINATION

The relevant institutions have approved the study protocol and consent procedures. The findings of the study will contribute to the understanding of sleep disturbance, and the ability to implement sleep monitoring methods within ICUs. Understanding the contribution of a clinical environment on sleep disturbance may provide insight into the need to address clinical environmental issues that may positively influence patient outcomes, and could dispel notions that the environment is a primary factor in sleep disturbance. The research findings will be disseminated via presentations at national and international conferences, proceedings and published articles in peer-reviewed journals.

TRIAL REGISTRATION NUMBER

ACTRN12615000945527; Pre-results.

摘要

引言

睡眠是一种静止状态,有助于促进重要的恢复过程,从而增强个体的生理和心理健康。入住重症监护病房(ICU)的患者会经历严重的睡眠障碍。尽管睡眠具有生物学重要性,但睡眠监测并非重症患者标准临床护理的一部分。目前存在未满足的需求,即评估一系列睡眠评估技术的可行性和准确性,这些技术有可能在ICU中广泛实施睡眠监测。

关键指标

本研究的共同主要结局指标是:确定运动加速度计监测(即活动记录仪)和睡眠主观评估(基于护理的观察和患者自我报告)相对于睡眠监测金标准(即多导睡眠图)在评估睡眠连续性和干扰方面的准确性和可行性。该研究的次要结局指标将包括:(1)睡眠障碍与环境因素(如噪音、光线和临床互动)之间的关联,以及(2)描述重症监护患者的睡眠结构。

方法与分析

一项前瞻性、单中心观察性设计,对睡眠监测技术进行受试者内评估。样本将包括80名成年人(18岁及以上),包括通气和非通气患者,入住三级ICU,Richmond躁动 - 镇静量表评分在+2(躁动)至 - 3(中度镇静)之间,预期住院时间>24小时。将使用多导睡眠图和活动记录仪对患者的睡眠质量、总睡眠时间和睡眠碎片化情况进行连续24小时监测。在24小时期间,将使用理查兹 - 坎贝尔睡眠问卷评估行为评估(护理观察)和患者的睡眠质量自我报告,通过卡罗林斯卡嗜睡量表评估主观嗜睡程度,并使用小睡眠问卷进行出院前调查,了解患者对睡眠质量和干扰因素的感知。还将研究睡眠障碍、噪音和光线水平以及临床互动频率之间的关联。声音和亮度水平将通过Extech SDL600和SDL400监测设备以1秒的时间间隔进行记录。临床互动将通过电子病历系统Metavision进行记录,该系统记录患者监测和临床护理情况。

伦理与传播

相关机构已批准研究方案和同意程序。该研究的结果将有助于理解睡眠障碍,以及在ICU中实施睡眠监测方法的能力。了解临床环境对睡眠障碍的影响可能有助于洞察解决可能对患者结局产生积极影响的临床环境问题的必要性,并可能消除认为环境是睡眠障碍主要因素的观念。研究结果将通过在国内和国际会议上的报告、会议论文集以及在同行评审期刊上发表文章的方式进行传播。

试验注册号

ACTRN12615000945527;预结果。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f8d4/5781106/e18dacd77818/bmjopen-2017-019704f01.jpg

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