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临床试验/NCT03141216
NCT03141216已完成不适用

Effects of Mechanical Ventilation on Controlled Volume, Controlled Pressure and Pressure Support in the Immediate Postoperative Period of Cardiac Surgery on Pulmonary Electrical Impedance and Patient-ventilator Asynchrony: a Parallel Clinical Trial

Universidade Federal de Pernambuco2 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2017年3月9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
入组人数
19
试验地点
2
主要终点
electrical impedance measures

研究概览

简要总结

This study evaluates the effects of VCV, PCV and PSV ventilatory modes during the immediate postoperative period on the variables resulting from regional and global pulmonary electrical impedance and diaphragmatic mobility, as well as perform ventilator synchrony analysis in PSV mode by mechanical ventilator. Half of the participants will receive VCV followed by PSV for weaning, while the other half will receive PCV followed by PSV for weaning.

详细描述

In the immediate postoperative period of cardiac surgery, patients are found under mechanical ventilatory support. Commonly, they are ventilated in controlled and assisted-controlled volume (VCV) or pressure (PCV) modes, with weaning at pressure support (PSV).

Systematic reviews indicate that there is no difference between the VCV and PCV ventilatory modes for some clinical outcomes or that the existing evidence is insufficient. The distribution of regional ventilation and diaphragmatic mobility can be measured from the use of electrical impedance tomography (EIT) and diaphragmatic ultrasonography (US) to clarify the physiological changes and / or mechanisms of adaptation of the organism submitted to controlled modes cycled at volume or at pressure and spontaneously flow cycled mode.

Besides EIT and US measures, gasometric, hemodynamic and respiratory data will also be recorded. The statistical analysis will be considered α≤0.05 for a statistically significant difference.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Double (Participant, 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

  • IMC 18.5-29.9 kg/m²
  • Two thoracic tubes (one mediastinal and one left-sided pleural)
  • under mechanical ventilation after surgery
  • submitted to intraoperative extracorporeal circulation

排除标准

  • Over 2h of cardiopulmonary bypass
  • Over 12h of post-operative mechanical ventilation
  • Post-operative bleeding above 500 ml in the first hour or above 300 ml in the first two hours
  • History of special conditions (neuromuscular and chronic pulmonary disease, thoracic deformity, abdominal distension).

研究组 & 干预措施

VCV+PSV

Experimental

volume controlled cycled, assisted-controlled cycled ventilation mode + pressure support ventilation mode. Progression of invasive ventilatory assistance as the patient recovers during post-surgery.

干预措施: VCV+PSV (Device)

PCV+PSV

Experimental

pressure controlled cycled, assisted-controlled cycled ventilation mode + pressure support ventilation mode. Progression of invasive ventilatory assistance as the patient recovers during post-surgery.

干预措施: PCV+PSV (Device)

结局指标

主要结局

electrical impedance measures

时间窗: 5 minutes of recording at each step of mechanical ventilation progression before extubation.

impedance variation data recorded by a tomograph.

次要结局

  • arterial gas blood analysis data(up to 12h, following routine care while patients are mechanically ventilated)
  • patient-ventilator synchrony(5 minutes of recording at each step of mechanical ventilation progression before extubation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Wagner Souza Leite

Master's Program student

Universidade Federal de Pernambuco

研究点 (2)

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