SPECTATOR: Perfusion Monitoring Before, During and After Lower Extremity Revascularization With Laser Speckle Contrast Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To assess the feasibility and the quantification of laser speckle contrast imaging for monitoring of perfusion of the lower extremities during and following revascularization
研究概览
简要总结
This study aims to evaluate the feasibility of Laser Speckle Contrast Imaging for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.
详细描述
Rationale: Lower extremity arterial disease (LEAD) arises from atherosclerotic obstruction in the lower limbs, which in turn leads to symptoms ranging from intermittent claudication to ulcer formation. As the disease progresses, patients often require revascularization to achieve limb salvage.
To improve prediction of clinical outcomes following revascularization, various techniques have been introduced to quantify tissue perfusion. Among these, near-infrared fluorescence imaging with indocyanine green (ICG NIRF) has gained attention. This method combines a laser light source with intravenous ICG administration to visualize perfusion. Although ICG NIRF appears promising for guiding revascularization strategies and predicting outcomes, its invasive nature, requiring dye injection, limits its use in outpatient settings.
Consequently, there is a need for a non-invasive, real-time technique that enables rapid and straightforward perfusion assessment. One such promising approach is laser speckle contrast imaging (LSCI). Therefore, this study aims to evaluate the feasibility of LSCI for perioperative perfusion assessment of the lower extremity before, during, and after revascularization.
Objective:The primary objective of this study is to evaluate the feasibility of laser speckle contrast imaging (LSCI) for monitoring perfusion in the lower extremities during and following revascularization.
Secondary objectives include correlating LSCI findings with the temperature of the patient's foot, comparing LSCI with near-infrared fluorescence imaging using indocyanine green (ICG NIRF) and exploring potential quantitative approaches such as the assessment of blood flow pulsatility.
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
- 否
入选标准
- •Scheduled for lower-extremity revascularization
- •Undergoing pre- and postoperative indocyanine near-infrared fluorescence perfusion measurements
排除标准
- •Any condition that the investigator considers to be potentially jeopardizing the patient's wellbeing or the study objectives
研究组 & 干预措施
Fontaine 2
干预措施: Laser Speckle Contrast Imaging (Diagnostic Test)
Fontaine 3
干预措施: Laser Speckle Contrast Imaging (Diagnostic Test)
Fontaine 4
干预措施: Laser Speckle Contrast Imaging (Diagnostic Test)
结局指标
主要结局
To assess the feasibility and the quantification of laser speckle contrast imaging for monitoring of perfusion of the lower extremities during and following revascularization
时间窗: Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures)
Feasibility
次要结局
- Correlation of pre-, intra- and postsurgery laser speckle contrast imaging (LSCI) findings with the pre-, intra- and post-temperature of the patient's foot(Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures))
- Comparative analysis of LSCI with standard of care near-infrared fluorescence imaging using ICG(Up to 48 hours (from pre-operative baseline measurement to the final postoperative measurement, performed on the same day for PTA procedures or on postoperative day 1 for bypass and TEA procedures))
- Clinical outcomes(Clinical outcome data (wound healing, limb salvage, complications) extracted from routine postoperative follow-up assessments, up to 6 weeks after revascularization; no additional study-specific measurements are performed at this follow-up visit)
- Effect of anesthesia induction on quantified LSCI perfusion values(Pre-anesthesia induction and within 15 minutes post-anesthesia induction)
- Exploratory assessment of blood flow pulsatility using LSCI(Intraoperative, during the reperfusion phase (in the subset of participants undergoing TEA or PTA procedures with intraoperative regional oximetry monitoring))
研究者
Joost R. van der Vorst, MD, PhD
dr
Leiden University Medical Center