Relationship Between Asynchronies and Sleep Disruption in Mechanically Ventilated Patients: a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies.
研究概览
简要总结
Mechanically ventilated (MV) patients in the Intensive Care Unit (ICU) are highly susceptible to sleep disruption. Several studies in the last 15 years have demonstrated an extremely poor sleep quality and abnormal sleep pattern evaluated by polysomnography (PSG) devices (the gold standard method for evaluating sleep quality and quantity).
Patient-ventilator interaction is frequently poor leading to asynchronies of varied type and consequences. Moderate-to-severe asynchronies are associated with longer mechanical ventilation, weaning failure and mortality.
The goal of this study is to look for an association between poor sleep quality and patient-ventilator asynchronies.
This study is an observational, physiological study investigating sleep quality and quantity in MV patients by recording portable PSG (from 22:00 to 08:00) at night while continuously monitoring 24h/day of patient-ventilator interaction (BetterCare system).
详细描述
This clinical physiological study took place after MV patients have survived the initial critical admission phase (severe hypoxemia or shock) and before approaching weaning.
After enrolment, a single night, sleep architecture was recorded using standard PSG (electroencephalography, right and left electrooculography, submental electromyography and electrocardiography) from 24:00 to 8:00. Pulse oximetry (SpO2) and heart rate will be recorded continuously during the PSG.
Assessment of delirium was performed using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) every 8 hours (at 08:00, 16:00 and 24:00) from day 0 until discharge.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Intubated and mechanically ventilated
排除标准
- •Presence of recent major central nervous system disease impairing consciousness with Glasgow Coma Scale ≤ 8 with intubation
- •Patients with a sleep breathing disorder when it is predominantly central sleep apnea; patients with predominantly obstructive sleep apnea can be included.
- •Severe hemodynamic instability (high dose of vasopressors).
- •Receiving muscle paralysis.
结局指标
主要结局
Correlation between sleep architecture using Odds Ratio Product (ORP) and asynchronies.
时间窗: 24 hours
ORP ranges and Sleep Architecture. Type and amount of asynchronies.
次要结局
- Comparison of sleep disturbances between diurnal and nocturnal asynchronies(24 hours)
- Correlation between asynchronies and delirium(28 days)
- Correlation between sleep disruption and delirium(28 dyas)
研究者
Carles Subirà Cuyàs
Principal Investigator
Althaia Xarxa Assistencial Universitària de Manresa