Hemodynamic Repercussions of Ventilator Hyperinflation Using Volume-controlled Ventilation: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Cardiac Output
研究概览
简要总结
Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, the literature is scarce concerning its safety and adverse effects. Thus, the aim of this study is to compare the hemodynamic repercussions of VHI in volume-controlled mode. In a randomized, controlled and crossover design, 24 mechanically ventilated patients will undergo 2 modes of ventilator hyperinflation (with and without an inspiratory pause) and a control intervention. Cardiac output, cardiac index, mean arterial pressure, pulmonary vascular resistance, systolic volume and other hemodynamic variables will be recorded during the interventions.
详细描述
Background: ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, the literature is scarce concerning its safety and adverse effects. Thus, the aim of this study is to compare the hemodynamic repercussions of VHI in volume-controlled mode.
Methods: in a randomized, controlled and crossover design, 24 mechanically ventilated patients will undergo 2 modes of ventilator hyperinflation (with and without an inspiratory pause of 2 seconds) and a control intervention. For the VHI interventions, the inspiratory flow will be set at 20 Lpm, and tidal volume will be increased until a peak pressure of 40cmH2O is achieved. During the control intervention, the patients will remain in volume-control ventilation with an inspiratory flow = 60Lpm and tidal volume = 6mL/IBW. The interval between interventions (washout) will be of 10 minutes or more, according to the time needed to recover the cardiac index to baseline values (maximum difference of 10%). Cardiac output, cardiac index, mean arterial pressure, pulmonary vascular resistance, systolic volume and other hemodynamic variables will be recorded during the interventions by using impedance cardiography.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients under mechanical ventilation for more than 48h
排除标准
- •mucus hypersecretion (defined as the need for suctioning < 2-h intervals),
- •absence of respiratory drive,
- •atelectasis,
- •severe bronchospasm,
- •positive end expiratory pressure > 10cmH2O,
- •PaO2-FiO2 relationship < 150,
- •mean arterial pressure < 60mmHg,
- •inotrope requirement equivalent to >15 ml/h total of adrenaline and noradrenalin,
- •intracranial pressure > 20mmHg
结局指标
主要结局
Change in Cardiac Output
时间窗: Baseline (before) and 10 minutes after the onset of VHI modesBasel
Estimation of cardiac output variation using thoracic bioimpedance
次要结局
- Change in Systolic Volume II(Baseline (before) and 5 minutes after the end of VHI modes)
- Change in Vascular pulmonary resistance(Baseline (before) and 10 minutes after the onset of VHI modes)
- Change in Mean Arterial Pressure(Baseline (before) and 10 minutes after the onset of VHI modes)
- Change in Cardiac Index II(Baseline (before) and 5 minutes after the end of VHI modes)
- Change in Vascular pulmonary resistance II(Baseline (before) and 5 minutes after the end of VHI modes)
- Change in Mean Arterial Pressure II(Baseline (before) and 5 minutes after the end of VHI modes)
- Change in Cardiac Index(Baseline (before) and 10 minutes after the onset of VHI modes)
- Change in Systolic Volume(Baseline (before) and 10 minutes after the onset of VHI modes)
- Change in Cardiac Output II(Baseline (before) and 5 minutes after the end of VHI modes)