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临床试验/NCT03327610
NCT03327610已完成不适用

Selecting the Best Ventilator Hyperinflation Settings Based on Physiologic Markers: Randomized Controlled Study

Centro Universitário Augusto Motta0 个研究点目标入组 30 人开始时间: 2016年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
主要终点
Pulmonary expansion

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, 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.

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, 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)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

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

Pulmonary expansion

时间窗: Ten minutes after the onset of intervention.

Percentage of tidal volume above the normal tidal volume (estimated as 6mL/kg).

Peak inspiratory to expiratory flow ratio

时间窗: 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)

Peak expiratory flow higher than 40 Lpm

时间窗: Ten minutes after the onset of intervention.

Dichotomous variable, defined as achieving a PEFR higher than 40 l/min

Difference between peak inspiratory and expiratory flows.

时间窗: Ten minutes after the onset of intervention.

Dichotomous variable, defined as achieving a difference higher than 17Lpm.

次要结局

  • Mean arterial pressure(Ten minutes after the onset of intervention.)
  • Heart Rate(Ten minutes after the onset of intervention.)

研究者

发起方
Centro Universitário Augusto Motta
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Silva Guimaraes

Associate Professor

Centro Universitário Augusto Motta

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