Pilot Study of Intraoperative Tissue Differentiation and Vascular Perfusion Using Intraoperative Hyperspectral Imaging (HSI) in Benign and Malignant Diseases of the Lung, Pleura and Mediastinum
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Oxygenation: Bronchus before lung resection
研究概览
简要总结
The aim of this study is to find out whether hyperspectral imaging enables bronchus stump and bronchus anastomosis oxygenation.
详细描述
The bronchus before lung resection and the bronchus stump or bronchus anastomosis, respectively, are investigated. The hyperspectral imaging camera head is placed and aligned over the surgical (camera and object distance: 30 cm for all measurements). The Field of view is illuminated by 8 halogen spots (20 W each) and 100 wavelengths in the wavelength range from 500 to 1000 nm were applied. The software calculates the tissue oxygenation [%] , organ-hemoglobin-index, near-infrared-Index and the tissue-water-index of the investigated tissue. The study was designed to investigate tissue oxygenation in the superficial (app. 1mm) and deeper layers (app. 4-6mm) of the bronchus before and after lung resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lung resection or other resection via thoracotomy
排除标准
- •Restriction of the ability to consent
结局指标
主要结局
Oxygenation: Bronchus before lung resection
时间窗: directly before lung resection
Tissue perfusion of the bronchus before lung resection: Oxygenation (StO2) in %: Relative O2 saturation of the blood in superficial tissue layers (penetration depth: approx. 1 mm)
Near Infrared Perfusion Index: Bronchus before lung resection
时间窗: directly before lung resection
Tissue perfusion of the bronchus before lung resection: Near Infrared Perfusion Index: Tissue perfusion in deeper tissue layers (penetration depth: 4-6mm)
Oxygenation: Bronchus stump or bronchus anastomosis after lung resection
时间窗: 10-15 minutes after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Oxygenation (StO2) in %: Relative O2 saturation of the blood the in superficial tissue layers (penetration depth: approx. 1 mm)
Tissue-Hemoglobin index: Bronchus before lung resection
时间窗: directly before lung resection
Tissue perfusion of the bronchus before lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue
Tissue-Water-Index: Bronchus stump or bronchus anastomosis after lung resection
时间窗: 10-15 minutes after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Water-Index: Existing water distribution in the tissue
Tissue-Water-Index: Bronchus before lung resection
时间窗: directly before lung resection
Tissue perfusion of the bronchus before lung resection: Tissue-Water-Index: Existing water distribution in the tissue
Near Infrared Perfusion Index: Bronchus stump or bronchus anastomosis after lung resection
时间窗: 10-15 minutes after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Near Infrared Perfusion Index: Tissue perfusion in deeper tissue layers (penetration depth: 4-6mm)
Tissue-Hemoglobin index: Bronchus stump or bronchus anastomosis after lung resection
时间窗: 10-15 minutes after lung resection
Tissue perfusion of the bronchus stump or bronchus anastomosis after lung resection: Tissue-Hemoglobin index: Existing hemoglobin distribution in the tissue
次要结局
未报告次要终点