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临床试验/NCT03630510
NCT03630510已完成不适用

Ventilator Hyperinflation With Increase of Inspiratory Time on Respiratory Mechanics: A Randomized Crossover Trial

Brazilian Institute of Higher Education of Censa2 个研究点 分布在 1 个国家目标入组 38 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
38
试验地点
2
主要终点
Static compliance of respiratory system

研究概览

简要总结

The investigators hypothesis is that the adjustment of the inspiratory time may optimize the distribution of ventilation and increase tidal volume, producing potential therapeutic effects on the displacement of secretions and respiratory mechanics. The objective of this study was To evaluate the effects of hyperinflation with the ventilator associated with increased inspiratory time on respiratory mechanics.

详细描述

A randomized crossover clinical trial was conducted with 38 mechanically ventilated patients with pulmonary infection. The order of hyperinflation or control (without changes in parameters) was randomized. Hyperinflation was performed for 5 minutes in the controlled pressure ventilation mode, with progressive increases of 5cmH2O until reaching a maximum pressure of 35cmH2O, maintaining PEEP. After reaching 35cmH2O, the inspiratory time and respiratory rate were adjusted so that the inspiratory and expiratory flows reached the baseline, respectively. Static compliance (Cest, sr), total resistance (Rsr) and airway resistance (Rva), slow pressure drop (ΔP2) and peak expiratory flow (PEF) were assessed before (PRÉ), immediately after the maneuver (POSSimed) and after aspiration (POSPasp). Two-way ANOVA was used for repeated measurements with Tukey post-test, considering a significant p <0.05.

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
None

入排标准

年龄范围
18 Years 至 80 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
  • Mucus hypersecretion (defined as the need for suctioning < 2-h intervals)

排除标准

  • Severe bronchospasm,
  • Positive end expiratory pressure > 10cmH2O,
  • PaO2-FiO2 relationship < 150,
  • Mean arterial pressure < 60mmHg,
  • Pleural effusion or pneumothorax undrained,
  • Bronchopleural or tracheoesophageal fistula,
  • Decompensated congestive heart failure.

研究组 & 干预措施

mechanical ventilator hyperinflation

Experimental

The VHI maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), 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. The maneuver was performed for 5 min, followed by tracheal aspiration.

干预措施: Ventilator hyperinflation (Other)

Control

No Intervention

To perform the control (CTRL), the patients were only positioned and aspirated, without alteration in ventilatory parameters.

结局指标

主要结局

Static compliance of respiratory system

时间窗: Baseline (before), immediately after VHI and five minutes after aspiration

Compliance was assessed through the occlusion maneuver at the end of inspiration, considering tidal volume, plateau pressure and PEEP. Three measurements were taken at each moment, the mean being used.

Total Resistance of respiratory system

时间窗: Baseline (before), immediately after VHI and five minutes after aspiration

The total resistance of the respiratory system was evaluated through the occlusion maneuver at the end of the inspiration, considering the resistive pressure, measured by the difference between the maximum plateau pressure. Three measurements were taken at each moment, the mean being used.

Airway Resistance

时间窗: Baseline (before), immediately after VHI and five minutes after aspiration

The airway resistance was assessed by means of the occlusion maneuver at the end of the inspiration, considering the rapid fall of the pressure immediately after the occlusion, measured by the difference between the maximum pressure and P1. Three measurements were taken at each moment, the mean being used.

Peak expiratory flow

时间窗: Baseline (before), immediately after VHI and five minutes after aspiration

The peak expiratory flow was evaluated through passive expiration, being considered the greatest value of the flow in the expiratory phase.

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

Chefe do Laboratório de Análise de Disfunções Pneumofuncionais (LADPF)

Brazilian Institute of Higher Education of Censa

研究点 (2)

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