Comparison of the Prevalence of Asynchronies During Mechanical Ventilation With Manual Versus Automatic Adjustment Ventilator Settings Using the INTELLISYNC+® (HAMILTON) Tool. A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Duration of asyncronies
研究概览
简要总结
Asynchronies between the patient and the artificial ventilator are a frequent problem. They may cause altered sleep, ventilator-induced lung injury, prolong length of ICU stay, cause neuro-psycologic complications and increase mortality. Although reducing their incidence through ventilator setting adjustments is possible, they frequently go undetected and it also requires that attendings remain at the bedside to repeatedly modify ventilator parameters. Ventilator systems may detect and automatically adjust parameters of mechanical ventilation. This would avoid delays in detection and adjustment if the intensivist is not immediately available. The investigators intend to study an automatic detection and adjustment tool which is incorporated in the ventilator software.
详细描述
The prevalence and time course of asynchronies will be evaluated in subjects under invasive (n=40) or non-invasive (n=40) mechanical ventilation. Intensivist-optimized ventilator settings will be compared to a software tool (Hamilton ventilators, Intellisync+) in its capacity to control and adjust the triggering and cycling by analysis of the ventilator curves.
The outcome variable is the percentage of the duration of asynchronies during the two 2-hour study periods.
This pilot study has a prospective, randomized cross-over design. The order of the 2 study periods will be randomized to either start with "control" with manual adjustment or "automated adjustment" with Intellisync+.
The total sample size is 80 subjects, 40 receiving invasive mechanical ventilation and 40 on non-invasive mechanical ventilation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Anonymized evaluation
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >17 years
- •Partial ventilatory support ("SPONT" mode) connected to Hamilton C1 model, irrespective of chronic restrictive or obstructive lung disease, categorized by RCexp (Expiratory time constant): restrictive (RCExp <0.6); obstructive (RCExp >0.9); normal (RCExp 0.6 - 0.9).
- •Software version SW3.0.0 or superior and the IntelliSync+ software tool available in invasive and non-invasive ventilation.
- •Presence of asyncronies in pressure and volume curves tracings of the ventilator.
- •Signed informed content.
排除标准
- •On extracorporeal respiratory support (ECMO or ECCO2R)
研究组 & 干预措施
Standard of Care
Optimized ventilator settings to control and reduce the number of asynchronies
Activated automatic detection and adjustment of asynchronies
Active mode of a mechanical ventilator software automatically detecting and adjusting ventilator parameters to control or reduce the number of events.
干预措施: Intellisync+ (Device)
结局指标
主要结局
Duration of asyncronies
时间窗: two hours per study arm
duration of asyncronies expressed as percentage of time during the respective 2-hour study periods
次要结局
未报告次要终点
研究者
Miguel Sanchez Garcia
Director Critical Care Department
Hospital San Carlos, Madrid