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临床试验/NCT02902549
NCT02902549已完成不适用

Real-time Quantitative Optical Perfusion Imaging in Surgery: a Prospective, Observational, In-vivo, Human, Single-center Study

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
26
试验地点
1
主要终点
Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with FI.

研究概览

简要总结

Surgeons are nowadays unable to visualize and quantitatively evaluate microvascularisation in real-time during surgery. Complications due to vascular compromise are a major problem, especially in reconstructive surgery. Poor blood perfusion leads to ischemia and even tissue necrosis. If, however, perfusion and ischemia could be monitored during surgery, then surgeons could change their reconstructive design and the anaesthesiologists could improve perfusion with fluids, inotropes or vasopressors, if necessary. Surgeons therefore need a tool that is able to image in high resolution (microvascularisation), direct, intra-operative, in 3D (to image thrombosis, luminal narrowing or distinct overlaying vessels) and that produces quantitative data to objectify image interpretation.

Optical techniques, based on the interaction of light with tissue, are able to image tissue at high resolution and in real-time. These techniques are FDA-approved and have emerged as powerful diagnostic tools in different departments of medicine, such as ophthalmology for visualizing retina vascularisation and dermatology for skin diagnostics.

In this study, investigators hypothesize that four novel optical technologies: Fluorescence Imaging, Laser Speckle Contrast Imaging, Optical Coherence Tomography and Sidestream Darkfield Microscopy are able to quantitatively image perfusion in real-time during surgery.

详细描述

Primary objective - Perfusion will be measured with all the techniques focussed on 4 areas; from 'good' to 'decreased' perfusion (biologically)

Fluorescence Imaging (FI): Time to intensity measurements at four sides Laser Speckle Contrast Imaging (LSCI): Perfusion Units Optical Coherence Tomography (OCT): Vessel density & decorrelation time Sidestream Darkfield Microscopy (SDF): Total vessel density, proportion of perfused vessels, perfused vessel density, max flow index, De Backer score, perfusion in mm/sec.

Differences in parameters between the four sites will be statistically be compared.

Secondary objectives

  • Relation of parameters to patient outcome in terms of adverse events.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥ 18 years - Scheduled for reconstructive surgery with free flap reconstruction or laparoscopic transhiatal and 3-stage transthoracic gastric tube surgery.

排除标准

  • Allergic to iodide (indocyanine green)
  • Hyper-thyroidism
  • Breastfeeding
  • No informed consent
  • Allergic to ephedrine
  • Ischaemic heart disease
  • Thyrotoxicosis
  • Autonomic thyroid adenomas
  • Intraoperative hypertension or tachycardia

结局指标

主要结局

Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with FI.

时间窗: 1 year

intensity/time (FI)

Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.

时间窗: 1 year

- Perfusion will be imaged with OCT and measured in total vessel density.

Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with LSCI.

时间窗: 1 year

flux in perfusion units (LSCI)

Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.

时间窗: 1 year

Perfusion will be imaged with SDF and measured in microvascular flow index.

次要结局

  • Distance of watershed to fundus (GT) or artery to tip (flap)(1 year)
  • Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with OCT.(1 year)
  • Difference in perfusion between the antrum and fundus (GT) or the artery origin and tip (free flap) measured with SDF.(1 year)
  • Measurement-time during surgery(30 minutes)
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(1 year)

研究者

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

S.S. Gisbertz

dr.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

研究点 (1)

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