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临床试验/NCT03631342
NCT03631342已完成不适用

Comparison Between Different Ventilator Hyperinflation Maneuvers

Brazilian Institute of Higher Education of Censa2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2017年3月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Peak Expiratory Flow

研究概览

简要总结

The hyperinflation ventilator was performed in different modalities and ventilatory adjustments, with total pressure of 40cmH2O. The inspiratory volume, inspiratory time, mean airway pressure, inspiratory and expiratory flow, and bias flow were evaluated.

详细描述

PURPOSE: To compare different ways of applying ventilator hyperinflation. METHODS: A randomized crossover clinical trial was performed with 30 patients (66.5 ± 17.3 years) with hypersecretion. The ventilator hyperinflation was performed in five ventilatory modalities for five minutes, with an interval of 2 hours, the order being determined by randomization: controlled ventilation at volume (VCV) with constant flow of 20 (VCV20) Lpm and 40 Lpm (VCV40), controlled ventilation pressure ventilation (PCV), controlled pressure ventilation associated with inspiratory time adjustment (PCV + Tins) and support pressure ventilation (PSV). In VCV mode, the volume was increased every 50mL, until reaching a maximum pressure of 40cmH2O. In the pressure controlled modes, the inspiratory pressure was increased every 5 cmH2O until the total pressure reached 40 cmH2O. The inspiratory time was adjusted so that the inspiratory flow reached the baseline. The following variables were evaluated: tidal volume, inspiratory time (Tins), mean airway pressure (Pmean), peak inspiratory flow (PIFR) and expiratory flow (PEFR), PIFR / PEFR and Bias Flow (PEFR-PIFR).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Pulmonary infection
  • Mechanically ventilated for more than 96 hours through pressure-assisted ventilation (PSV) or pressure-controlled ventilation (PCV)
  • Static compliance between 30 and 70 mL/cmH2O
  • PEEP between 5 and 8 cmH2O.

排除标准

  • Hemodynamic instability
  • Non-drained pleural effusion or pneumothorax
  • Intracranial hypertension
  • Bronchospasm
  • Adult respiratory distress syndrome (ARDS)
  • Decompensated congestive heart failure

研究组 & 干预措施

PSV

Experimental

Pressure support ventilation mode, with progressive increases of 5 cmH2O at inspiratory pressure, until reaching Pmax of 40 cmH2O. The expiratory sensitivity was adjusted by 25% for all patients.

干预措施: PSV (Other)

VCV20

Experimental

Volume-controlled ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O.

干预措施: VCV20 (Other)

VCV40

Experimental

Volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the maximum pressure reached 40cmH2O.

干预措施: VCV40 (Other)

PCV+Tins

Experimental

Pressure controlled ventilation mode and inspiratory pressure was increased every 5cmH2O, until the maximum pressure of 40 cmH2O was reached. The inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP.

干预措施: PCV+Tins (Other)

PCV

Experimental

Pressure controlled ventilation mode, inspiratory time of 1 second. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O.

干预措施: PCV (Other)

结局指标

主要结局

Peak Expiratory Flow

时间窗: Five minutes after the onset of intervention

maximal expiratory flow in 2 cycles

PIFR/PEFR

时间窗: Five minutes after the onset of intervention

Peak inspiratory to expiratory flow ratio

Bias Flow

时间窗: Five minutes after the onset of intervention

Difference between peak inspiratory and expiratory flows

Inspiratory Volume

时间窗: Five minutes after the onset of intervention

Inspiratory volume reached in each mode of ventilator hyperinflation, under a maximum pressure of 40cmH2O

Mean Pressure

时间窗: Five minutes after the onset of intervention

airway mean pressure measured on the mechanical ventilator in 2 cycles

Peak Inspiratory Flow

时间窗: Five minutes after the onset of intervention

Maximal inspiratory flow in 2 cycles

Inspiratory time

时间窗: Five minutes after the onset of intervention

inspiratory time necessary for the inspiratory flow to reach the baseline or according to the settings of each modality

次要结局

未报告次要终点

研究者

发起方
Brazilian Institute of Higher Education of Censa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luciano Matos Chicayban

Principal Investigator

Brazilian Institute of Higher Education of Censa

研究点 (2)

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