Prospective Randomized Controlled Trial to Compare and Analyze the Effects of Sound Masking and Reduction Techniques on Heart Rate and Blood Pressure Variability in Critically Ill Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Nocturnal LF/HF ratio (a.u.)
研究概览
简要总结
The goal of the project is to determine the effects of noise masking and noise reduction on stress related physiological parameters in critically ill patients admitted to the intensive care unit.
详细描述
Sleep deprivation is common in critically ill patients in the intensive care unit (ICU) and may impair recovery. While noise is widely cited as the most common cause of sleep disruption in the ICU setting, its contribution to sympathetic activity in critically ill patients is not known. This is an important knowledge gap, because noise initiates a sequence of physiological changes including vasoconstriction, raised diastolic blood pressure, pupil dilatation and muscle tension. Furthermore, noise is implicated in sympathetic arousals, resulting in a release of adrenaline which prevents relaxation and consequently prevents the patient from falling asleep.
The investigators plan to study the effect of noise masking and noise reduction on stress related physiological parameters in critically ill patients admitted to the ICU. Subjects will be randomized into 3 separate groups: control, noise reduction, and noise masking. The investigators will compare the heart rate and blood pressure variability between and within the groups to determine the effects of treatment assignment on these variables. Non-invasive measurements obtained from the bedside monitor will be collected using physiological data acquisition software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18-99 years who are expected to receive care on an adult critical care unit for at least 24 hours
排除标准
- •Admission for drug overdose or with a known substance abuse disorder
- •Untreated sleep apnea disorder, narcolepsy, REM sleep behavior disorder, parasomnia, restless leg syndrome or other sleep disorder
- •Use of hearing aids, or known significant conductive or sensory hearing loss
- •Ventilator support via an endotracheal tube
- •Use of vasopressors
- •Unresponsive or delirious
- •Subjects with known Dementia, Parkinson's disease, or other neurodegenerative disorder
- •Subjects with a pacemaker or who have received cardiac transplant
结局指标
主要结局
Nocturnal LF/HF ratio (a.u.)
时间窗: Day 1 of study
The effect of group assignment on nocturnal (8pm to 8am) low frequency/high frequency (LF/HF) ratio will be determined.
次要结局
- Hospital mortality (%)(Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.)
- Incidence of ICU delirium(Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment)
- Nocturnal heart rate (bpm)(Day 1 of study)
- Nocturnal RMSSD (ms)(Day 1 of study)
- Nocturnal blood pressure (mm Hg)(Day 1 of study)
- Hospital length of stay (days)(Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.)
- Discharged home (%, versus discharge to another health care facility or died)(Assessed at the time of hospital discharge up to a maximum of 28 days after enrollment, and averaging 6 days after enrollment.)
- ICU length of stay (days)(Assessed at the time of ICU discharge up to a maximum of 28 days after enrollment, and averaging 4 days after enrollment.)
研究者
Brian Gehlbach
Clinical Associate Professor
University of Iowa