Contribution to the Understanding of the Involvement of Mechanical Ventilation in ICU Patients Sleep Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Sleep fragmentation index
研究概览
简要总结
Sleep's deficiencies are very common in intensive care. Mechanical ventilation is a known factor in this deterioration.The investigators hypothesize that close-loop ventilation mode (Intellivent-ASV) is able to minimize sleep deterioration, adjusting ventilation to the patient needs.
详细描述
In intensive care, conventional mechanical ventilation (pressure support) generates apneas and asynchronies during sleep. Intellivent-ASV would be able to avoid apneas, providing controlled cycles when respiratory rate become too low. Moreover, the constant adjustment of ventilatory parameters to the patient needs would avoid asynchronies between the ventilator and the patient ventilatory drive.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 94 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patient under invasive mechanical ventilation since at least 6 hours and for expected at least 48 hours duration, including a continuous period of 24h, from 2 p.m. to 2 p.m. the next day.
- •Age > 18 years
- •Body Mass Index < 40
- •informed consent signed by the family
排除标准
- •patient requiring neuo-muscular blocking agent or deep sedation enough to abolish spontaneous ventilatory effort
- •patient with encephalopathy regardless of origin
- •Patient with Glasgow coma scale score < 8
- •Patient abusing of drug or alcohol
- •patient with a contraindication for placement of a nasogastric tube such that sufferers of esophageal or gastric ulcer, tumors, diverticulitis or bleeding varices or patients with sinusitis epistaxis or having recently been operated on the nose or pharynx
- •Patient with bleeding disorders
- •Patient with unstable respiratory situation as defined by a arterial oxygen partial pressure and inspired oxygen fraction ratio (PaO2/FiO2) < 100 mmHg with positive end expiratory pressure (PEEP) > 12 cmH2O
- •Patient with unstable hemodynamic situation as defined by Systolic Blood Pressure (SBP) < 75 mmHg despite a therapeutic optimization
- •Inclusion in another research protocol submitted to consent
结局指标
主要结局
Sleep fragmentation index
时间窗: 12 hours
= number of awakenings and arousals per hour of sleep
次要结局
- duration of sleep episodes(12 hours)
- Distribution of the sleep(12 hours)