Selecting the Best Ventilator Hyperinflation Settings (VHI1)
2017年10月27日 更新者：Fernando Silva Guimaraes、Centro Universitário Augusto Motta
Selecting the Best Ventilator Hyperinflation Settings Based on Physiologic Markers: Randomized Controlled Study
Ventilator hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique.
Thus, the aim of this study was to compare six modes of VHI, concerning physiological markers of efficacy and safety criteria, in order to support the optimal VHI settings selection for mechanically ventilated patients.
In a randomized, controlled and crossover study, 30 mechanically ventilated patients underwent 6 modes of ventilator hyperinflation.
The maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), overdistension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.
研究概览
详细说明
Background: Ventilator Hyperinflation (VHI) has been shown to be effective in improving respiratory mechanics, secretion removal, and gas exchange in mechanically ventilated patients; however, there are no recommendations on the best ventilator settings to perform the technique. Thus, the aim of this study was to compare six modes of VHI, concerning physiological markers of efficacy and safety criteria, in order to support the optimal VHI settings selection for mechanically ventilated patients.
Methods: In a crossover study, every included mechanically ventilated patient underwent six modes of VHI in a randomized order: Volume Control Continuous Mandatory Ventilation (VC-CMV) with inspiratory flow = 20Lpm (VC-CMV20), VC-CMV with inspiratory flow = 50Lpm (VC-CMV50), Pressure Control Continuous Mandatory Ventilation (PC-CMV) with inspiratory time = 1s. (PC-CMV1), PC-CMV with inspiratory time = 3s. (PC-CMV3), Pressure Support Ventilation (PSV) with cycling off = 10% of peak inspiratory flow (PSV10), and PSV with cycling off = 25% of peak inspiratory flow (PSV25). The maximum expansion (tidal volume), expiratory flow bias criteria (inspiratory and expiratory flow patterns), over-distension (alveolar pressure), asynchronies and hemodynamic variables (mean arterial pressure and heart rate) were assessed during the interventions.
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients under mechanical ventilation for more than 48h
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
无干预：BASELINE
The subjects were kept in their current ventilatory mode.
|
|
|
实验性的：VC-CMV20
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 20Lpm.
|
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV).
The inspiratory flow was set at 20Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved.
After achieving the target pressure, this ventilatory regimen lasted 15 minutes.
Positive end expiratory pressure and the inspired oxygen fraction were not modified.
|
|
实验性的：VC-CMV50
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory flow of 50Lpm.
|
Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV).
The inspiratory flow was set at 50Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved.
After achieving the target pressure, this ventilatory regimen lasted 15 minutes.
Positive end expiratory pressure and the inspired oxygen fraction were not modified.
|
|
实验性的：PC-CMV1
Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 1 second.
|
Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1).
The inspiratory time was set at 1 second and the pressure control was increased until a peak pressure of 40cmH2O was achieved.
After achieving the target pressure, this ventilatory regimen lasted 15 minutes.
Positive end expiratory pressure and the inspired oxygen fraction were not modified.
|
|
实验性的：PC-CMV3
Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1) with an inspiratory time of 3 seconds.
|
Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1).
The inspiratory time was set at 3 seconds and the pressure control was increased until a peak pressure of 40cmH2O was achieved.
After achieving the target pressure, this ventilatory regimen lasted 15 minutes.
Positive end expiratory pressure and the inspired oxygen fraction were not modified.
|
|
实验性的：PSV10
Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 10% of peak inspiratory flow.
|
Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV).
The cycling off was set at 10% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved.
After achieving the target pressure, this ventilatory regimen lasted 15 minutes.
Positive end expiratory pressure and the inspired oxygen fraction were not modified.
|
|
实验性的：PSV25
Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV) with a cycling off of 25% of peak inspiratory flow.
|
Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV).
The cycling off was set at 25% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved.
After achieving the target pressure, this ventilatory regimen lasted 15 minutes.
Positive end expiratory pressure and the inspired oxygen fraction were not modified.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Peak inspiratory to expiratory flow ratio
大体时间：Ten minutes after the onset of intervention.
|
Dichotomous variable, defined as achieving a peak inspiratory flow rate (PIFR) less than 90% of the peak expiratory flow rate (PEFR)
|
Ten minutes after the onset of intervention.
|
|
Peak expiratory flow higher than 40 Lpm
大体时间：Ten minutes after the onset of intervention.
|
Dichotomous variable, defined as achieving a PEFR higher than 40 l/min
|
Ten minutes after the onset of intervention.
|
|
Difference between peak inspiratory and expiratory flows.
大体时间：Ten minutes after the onset of intervention.
|
Dichotomous variable, defined as achieving a difference higher than 17Lpm.
|
Ten minutes after the onset of intervention.
|
|
Pulmonary expansion
大体时间：Ten minutes after the onset of intervention.
|
Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).
|
Ten minutes after the onset of intervention.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Mean arterial pressure
大体时间：Ten minutes after the onset of intervention.
|
Mean arterial pressure verified using the multi-parameter monitor.
|
Ten minutes after the onset of intervention.
|
|
Heart Rate
大体时间：Ten minutes after the onset of intervention.
|
Heart rate verified using the multi-parameter monitor.
|
Ten minutes after the onset of intervention.
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：FERNANDO S GUIMARAES, PhD、Centro Universitário Augusto Motta
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Berney S, Denehy L. A comparison of the effects of manual and ventilator hyperinflation on static lung compliance and sputum production in intubated and ventilated intensive care patients. Physiother Res Int. 2002;7(2):100-8. doi: 10.1002/pri.246.
- Lemes DA, Zin WA, Guimaraes FS. Hyperinflation using pressure support ventilation improves secretion clearance and respiratory mechanics in ventilated patients with pulmonary infection: a randomised crossover trial. Aust J Physiother. 2009;55(4):249-54. doi: 10.1016/s0004-9514(09)70004-2.
- Thomas PJ. The effect of mechanical ventilator settings during ventilator hyperinflation techniques: a bench-top analysis. Anaesth Intensive Care. 2015 Jan;43(1):81-7. doi: 10.1177/0310057X1504300112.
- Ntoumenopoulos G, Shannon H, Main E. Do commonly used ventilator settings for mechanically ventilated adults have the potential to embed secretions or promote clearance? Respir Care. 2011 Dec;56(12):1887-92. doi: 10.4187/respcare.01229. Epub 2011 Jun 17.
- Anderson A, Alexanders J, Sinani C, Hayes S, Fogarty M. Effects of ventilator vs manual hyperinflation in adults receiving mechanical ventilation: a systematic review of randomised clinical trials. Physiotherapy. 2015 Jun;101(2):103-10. doi: 10.1016/j.physio.2014.07.006. Epub 2014 Oct 6.
- Davies JD, Senussi MH, Mireles-Cabodevila E. Should A Tidal Volume of 6 mL/kg Be Used in All Patients? Respir Care. 2016 Jun;61(6):774-90. doi: 10.4187/respcare.04651.
- de Wit M. Monitoring of patient-ventilator interaction at the bedside. Respir Care. 2011 Jan;56(1):61-72. doi: 10.4187/respcare.01077.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年7月1日
初级完成 (实际的)
2017年8月1日
研究完成 (实际的)
2017年8月1日
研究注册日期
首次提交
2017年10月27日
首先提交符合 QC 标准的
2017年10月27日
首次发布 (实际的)
2017年10月31日
研究记录更新
最后更新发布 (实际的)
2017年10月31日
上次提交的符合 QC 标准的更新
2017年10月27日
最后验证
2017年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.