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临床试验/NCT03942393
NCT03942393已完成不适用

Noise in the Intensive Care Care Unit and Its Influence on Cortical Arousals: a Prospective Cohort Study

Università degli Studi di Brescia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Number of cortical arousals per hour

研究概览

简要总结

This is a prospective observational study in an Italian general-neurologic ICU. Sleep was monitored during the night, using a simplified polysomnography(PSG), for a maximum of five consecutive nights. Adults patients were eligible for the study if they remained in the ICU for at least 24 hours

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • older than 18
  • recovered in ICU
  • remained in the ICU for at least 24 hours.

排除标准

  • 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

结局指标

主要结局

Number of cortical arousals per hour

时间窗: Up to 5 consecutive nights from 10:00 pm to 7:00 am

analyzed as binary variables:\< 43 or \> 43per hour regression

次要结局

  • presence of REM phases(Up to 5 consecutive nights from 10:00 pm to 7:00 am)
  • Duration of SWS phases(Up to 5 consecutive nights from 10:00 pm to 7:00 am)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisa Seghelini,MD

Principal Investigator

Università degli Studi di Brescia

研究点 (1)

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