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临床试验/NCT01191606
NCT01191606Unknown2 期

Pressure-controlled Versus Volume-controlled Ventilation During Protective One Lung Ventilation for Thoracic Surgery

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2010年6月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
入组人数
34
试验地点
1
主要终点
arterial oxygenation differences

研究概览

简要总结

The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.

详细描述

One-lung ventilation (OLV) during thoracic surgery, in particular, video-assisted thoracic surgery is a standard practice to facilitate surgical exposure, but arterial hypoxemia has been a serious complication during one lung ventilation. Furthermore, recent studies have shown that one lung ventilation with a conventional tidal volume can involve lung injury associated with alveolar overdistension and high airway pressure. Therefore, lung protective ventilation with a low tidal volume during one lung ventilation has been suggested, and a recent study showed that protective ventilation during lung cancer surgery was associated with improved postoperative respiratory outcomes such as reduced incidence of acute lung injury and atelectasis.

During protective one lung ventilation limiting airway pressure and using low tidal volume, it is important to provide uniform alveolar expansion and maintain adequate oxygenation. A previous study suggested that the decelerating inspiratory flow delivery used in pressure controlled ventilation improved ventilation/perfusion distribution and arterial oxygenation during one lung ventilation5. Moreover, according to a recent study during laparoscopic obesity surgery, pressure-controlled ventilation improved oxygenation compared with volume controlled ventilation, which was associated with higher instantaneous flow peaks and a better alveolar recruitment6. On the other hand, other studies showed that ventilatory mode during one lung ventilation did not affect arterial oxygenation. However, these studies were performed during mechanical ventilation using conventional tidal volume, and the effect of ventilatory mode during protective one lung ventilation on oxygenation has not been clearly determined yet.The aim of this study is to determine the effects of pressure controlled ventilation during protective one lung ventilation on blood gases, airway pressures and hemodynamic variables compared with volume controlled ventilation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients (ASA physical status I-III) undergoing elective thoracic surgery in the lateral position with at least 1 h of one lung ventilation

排除标准

  • patients with major organ dysfunction, hemodynamic instability, or increased intracranial pressure

研究组 & 干预措施

Group A

Active Comparator

the exchange of ventilatory mode from volume controlled ventilation to pressure controlled ventilation

干预措施: the change of ventilatory mode (Procedure)

Group B

Active Comparator

the exchange of ventilatory mode from pressure controlled ventilation to volume controlled ventilation

干预措施: the change of ventilatory mode (Procedure)

结局指标

主要结局

arterial oxygenation differences

时间窗: four time points during operation

(1) during two-lung ventilation using VCV before initiation of OLV (baseline); (2) during OLV 30 min after the first randomized ventilation mode; (3) 30 min after the second ventilation mode; and (4) 30 min after reestablishing two-lung ventilation.

次要结局

  • mean inspiratory pressure (Pmean)(four time points during operation)
  • plateau inspiratory pressure (Pplateau)(four time points during operation)
  • peak inspiratory pressure (Ppeak)(four time points during operation)

研究者

申办方类型
Other

研究点 (1)

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