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临床试验/NCT03056885
NCT03056885已完成不适用

Does a Protective One Lung Ventilation Strategy Reduce the Inflammatory Cytokine Local Response After Pulmonary Resection?

University of Roma La Sapienza0 个研究点目标入组 28 人开始时间: 2015年11月2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
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

Experimental

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

Experimental

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

发起方
University of Roma La Sapienza
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohsen Ibrahim

Medical Director

University of Roma La Sapienza

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