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临床试验/NCT03282032
NCT03282032已完成不适用

Preconditioning of One-lung Ventilation for Lung Protection

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2017年11月22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
136
试验地点
2
主要终点
P/F ratio

研究概览

简要总结

To observe the effect of one-lung ventilation (OLV) preconditioning on perioperative oxygenation during thoracic surgery.

详细描述

For lung isolation and better surgical view, one-lung ventilation(OLV) is essential for thoracic surgery. However, OLV may cause serious pulmonary complications due to intraoperative hypoxia.

Animal studies showed a positive effect of OLV preconditioning (Intermittent OLV before surgical intervention) on perioperative pulmonary oxygenation.

Thus, we designed a study to observe the effect of OLV preconditioning on perioperative oxygenation during thoracic surgery

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
Triple (Participant, Care Provider, 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

  • Elective thoracic surgery which requires one-lung ventilation with lateral decubitus position

排除标准

  • Patients with severe cardiopulmonary disease, COPD, previous surgical history of pulmonary disease
  • Thoracic surgery for pneumonectomy

研究组 & 干预措施

One-lung ventilation

Experimental

Before surgical incision, 2-min of OLV followed by 2-min of TLV (1 cycle) is performed for 5 cycles.

干预措施: One-lung ventilation (Other)

Two-lung ventilation

No Intervention

Maintain two-lung ventilation until surgical incision

结局指标

主要结局

P/F ratio

时间窗: 30min after surgical incision

PaO2/FIO2 ratio

Incidence of hypoxemia

时间窗: during one-lung ventilation, up to 5 hours

SpO2 \< 95%

次要结局

  • Pulmonary complications(6, 24, 48 hours after surgery, during hospital stay.)

研究者

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

Jeong-Hwa Seo

Professor

Seoul National University Hospital

研究点 (2)

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