Vascular Disease，Peripheral
Conditions
Brief summary
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.
Detailed description
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. Study design: This study will be a prospective cohort study. Study population: Adult patients undergoing a revascularization of the lower extremity due to peripheral artery disease. Such revascularization can be bypass surgery, thrombo-endarterectomy (TEA), or endovascular percutaneous transluminal angioplasty (PTA). Intervention: Patients will undergo peri-operative and post-operative LSCI. Main study parameters/endpoints: The main study parameters are the quantified perfusion parameters measured with LSCI. Nature and extent of the burden and risks associated with participation. The use of the LSCI device is not expected to cause any adverse effects, as it employs a low-intensity near-infrared laser to illuminate the skin. The photon energy and illumination power used are well below levels that could cause tissue damage and are therefore considered safe for human skin. All measurements are performed alongside standard assessments or routine outpatient clinic appointments. The intraoperative measurement does not extend the duration of the surgical procedure. Given the short duration of each measurement (5-10 seconds), no additional burden on patients is anticipated.
Interventions
DIAGNOSTIC_TESTLaser Speckle Contrast Imaging
Measurement with LSCI device
Sponsors
Leiden University Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Scheduled for lower-extremity revascularization * Undergoing pre- and postoperative indocyanine near-infrared fluorescence perfusion measurements
Exclusion criteria
Any condition that the investigator considers to be potentially jeopardizing the patient's wellbeing or the study objectives
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the feasibility and the quantification of laser speckle contrast imaging for monitoring of perfusion of the lower extremities during and following revascularization | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Temperature |
| 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) | ICG |
| 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 | Correlation of quantified LSCI recordings to clinical outcomes |
| Effect of anesthesia induction on quantified LSCI perfusion values | Pre-anesthesia induction and within 15 minutes post-anesthesia induction | Exploratory comparison of quantified laser speckle perfusion units (LSPU) in the plantar region of interest measured before versus within 15 minutes after induction of anesthesia (prior to revascularization), to assess whether anesthesia induction is associated with a change in LSCI-derived perfusion values. Measurement setup and non-invasive LSCI acquisition procedure are unchanged from the pre-anesthesia measurement; no additional burden or risk to participants. |
| 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) | Exploratory, opportunistic analysis performed only in the subset of participants for whom intraoperative INVOS regional oximetry data are available as part of standard care; not assessed in all participants |
Countries
Netherlands
Outcome results
None listed