Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 主要终点
- local cytokine inflammatory response in the two study groups
研究概览
简要总结
This study evaluates the local cytokine inflammatory response during one lung ventilation in patients undergoing pulmonary lobectomy or wedge resection. We compare two different ventilation strategies: a conventional strategy with a protective strategy.
详细描述
One-lung ventilation (OLV) is a ventilation procedure used for pulmonary resection often causing lung injury. International guidelines have recommended for years the use of conventional ventilation (CV) with high tidal volume (VT) (8-10 ml\kg).A body of recent evidences have shown that conventional ventilation can reduce systemic oxygenation, increase inflammatory products and cause lung tissue damage. In this study we compare the conventional strategy , consisted of Vt 10 mL/kg, with the protective strategy, consisted of Vt 5 mL/kg. Both Vt were based on predicted body weight (PBW). Broncho-alveolar lavages (BAL) are selectively performed in the dependent (ventilated) lung before and at the end of the OLV. The levels of pro-inflammatory (IL-1α, IL-1β, IL-6, IL-8, TNF) and anti-inflammatory (IL-2, IL-4, IL-10, INFγ) cytokines are evaluated. We also evaluate patients clinical outcomes in terms of incidence of postoperative respiratory complications and length of stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Patients undergoing elective lobectomy and wedge resection
排除标准
- •emergency surgery, pregnancy, patient refusal, inability to give consent, age ≤ 18 years and ≥ ASA IV
研究组 & 干预措施
Conventional One-lung ventilation
The patients received a Tidal volume of 10 ml/kg (based on Predicted body weight)
干预措施: Conventional One-Lung Ventilation (Other)
Protective One-Lung Ventilation
The patients received a Tidal volume of 5 ml/kg (based on Predicted body weight)
干预措施: Protective One-lung ventilation (Other)
结局指标
主要结局
local cytokine inflammatory response in the two study groups
时间窗: Change from Baseline cytokines level and the end of surgery (about 60 minutes)
The levels of cytokines were evaluated in broncho-alveolar lavage (BAL)
次要结局
- incidence of postoperative respiratory in the two study groups(within 48 hours of the operation)
- lenght of stay in the two study groups(1 month)
研究者
Mohsen Ibrahim
Medical Director
University of Roma La Sapienza
