Noise in the Intensive Care Care Unit and Its Influence on Cortical Arousals and Sleep Phases
Noise in the Intensive Care Care Unit and Its Influence on Cortical Arousals: a Prospective Cohort Study
研究概览
地位
条件
详细说明
This is a prospective observational study conducted from April 2016 to October 2017 in the general-neurologic ICU In a university-affiliated hospital serving a population of 1 million habitant in the north-east of Italy. Patients were considered eligible if they were older than 18 and remained in the ICU for at least 24 hours. Patients with anamnestic severe dementia, severely decreased mental state defined as Richmond Agitation-Sedation Scale (RASS) lower than -3, and language barrier were excluded. Patients coming from other hospitals were excluded, because they might have been treated with long-lasting sleep or sedative drugs, which could deeply modify sleep quality. Patients needing continuous infusion of sedative drugs were also excluded since this could interfere with the interpretation of PSG data. Finally, patients with frontal wounds, brain lesions in the frontal lobes, external ventricular drainage and noninvasive mechanical ventilation were excluded because of the impossibility to position the PSG device.
The study was conducted in accordance with the Declaration of Helsinki and was approved by the local Ethics Committee of Brescia (NP 23332). Patients' informed consent was waived due to the lack of definition of a legal representative of temporarily incapacitated adult patients in the Italian legislation. The informed consent was obtained from the surviving patients as soon as they regained their mental competency. Family members received detailed information on the study scope and protocol. .
Sleep was monitored using a simplified PSG, Sleep Profiler (Advanced Brain Monitoring) with the device placed by the nursing staff, from 10:00 pm to 7:00 am, for a minimum of one night to a maximum of five consecutive nights . In case of occurrence of any of the exclusion criteria, such as positioning of external ventricular drainage, the PSG monitoring was interrupted. The authors collected data on age, sex, the Simplified Acute Physiology Score (SAPS II) reason for ICU admission, length of ICU stay, and presence of delirium, assessed three times daily using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). Any administration of drugs that could influence sleep were also recorded, including benzodiazepine as anxiolytics, opioids, dexmedetomidine, zolpidem, and melatonin.
The Sleep Profiler consists of a band with three channels for EEG, one channel for the electromyography of the masseter muscle (a touch proof connector with two electrodes), a plethysmography for heart rate, a microphone to register both ICU noise and patient snoring, and a 3D accelerometer to record head movements23. The registered parameters were then analyzed by a software that identifies sleep stages and Cortical Arousals (CA), and a report was generated for each night.
The authors analyzed the association of nocturnal noise, defined as the percentage of Total Sleep Time (TST) during which noise exceeds 40 decibel (dB), with duration of Rapid Eye Movement (REM )and Slow Wave Sleep (SWS) phases, expressed as a percentage of TST, and number of CAs.
STATISTICAL ANALYSIS Characteristics of the study population were summarized as number (percentage) for binary variables, and as mean (standard deviation, SD) or median (interquartile range, IQR), as appropriate, for continuous variables.
The study outcomes were duration of the REM and SWS stages and number of CAs, all analyzed as binary variables: REM: 0% or > 0% of the TST; SWS: ≤9% or > 9% of TST (threshold previously used in the literature24,25); CAs: ≤43 or >43 CAs per hour (threshold corresponding to the median value in our ICU, in the absence of information from the literature).
The association of noise with REM, SWS and CAs was analyzed using mixed-effect logistic regression models for repeated measures (measurements over nights for each patient), adjusting for SAPS II, age and sex as potential confounders. A sensitivity analysis were also performed in which further adjustment for the administration of drugs influencing sleep were added. Results are presented as odds ratio (OR) and 95% confidence interval (95% CI).
All statistical analyses were performed using STATA (Stata Corp, Texas, USA).
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Brescia、意大利、25123
- Spedali Civili, Anestesia e Rianimazione 2
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- older than 18
- recovered in ICU
- remained in the ICU for at least 24 hours.
Exclusion Criteria:
- patients with anamnestic severe dementia
- patients with severely decreased mental state (defined as Richmond Agitation-Sedation Scale, RASS, lower than -3)
- presence of language barrier
- patients coming from other hospitals
- patients needing continuous infusion of sedative drugs
- patients with frontal wounds, brain lesions in the frontal lobes, external ventricular drainage and noninvasive mechanical ventilation were excluded because of the impossibility to position the PSG device
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of cortical arousals per hour
大体时间:Up to 5 consecutive nights from 10:00 pm to 7:00 am
|
analyzed as binary variables:< 43 or > 43per hour regression
|
Up to 5 consecutive nights from 10:00 pm to 7:00 am
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
presence of REM phases
大体时间:Up to 5 consecutive nights from 10:00 pm to 7:00 am
|
analyzed as binary variables:0% or > 0% of Total sleep time
|
Up to 5 consecutive nights from 10:00 pm to 7:00 am
|
Duration of SWS phases
大体时间:Up to 5 consecutive nights from 10:00 pm to 7:00 am
|
analyzed as binary variables: < 9% or > 9% of Total Sleep Time
|
Up to 5 consecutive nights from 10:00 pm to 7:00 am
|
合作者和调查者
调查人员
- 首席研究员:ELISA SEGHELINI、II Servizio Rianimazione,, Spedali Civili Brescia
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.