Perfusion monitoring in lower limbs of patients with peripheral arterial occlusive disease with continuous ICG video angiography - A pilot study

• Conditions: Peripheral arterial occlusive disease; 10003216

• Registration Number: NL-OMON51744
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

Patients:

- Written informed consent
- Rutherford class 4-6
- Occlusion at the level of the iliac or femoral arteries
- Unilateral disease. Control leg must have an ABI >= 0.8, no rest pain, and no
ulcers

Exclusion Criteria

- Insufficient knowledge of the Dutch language, illiteracy, or language barrier.
- Lower leg fracture within the past 12 months.
- (Partial) amputation of one of the feet and/or legs.
- Known hypersensitivity to indocyanine green or to sodium iodide.
- Hyper-thyroidism and autonomic thyroid adenomas.
- Renal insufficiency.
- Concomitant use of the following: anticonvulsants, bisulphite compounds,
haloperidol, heroin, meperidine, metamizole, methadone, morphium,
nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, cyclopropane,
probenecid, and rifamycin.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Success of skin perfusion measurements of lower limb tissue with continuous<br /><br>ICG-VA in PAOD patients (Rutherford class 4-6). Success is defined as the<br /><br>ability to detect hypo perfusion in the diseased leg in comparison with the<br /><br>patient's contralateral control leg with continuous ICG-VA in at least half the<br /><br>patients with good signal quality and sufficient sound to noise ratio. Good<br /><br>signal quality defined as: anatomy of interest identifiable and centred in the<br /><br>camera's field of view; no interference from natural lights (e.g. daylight); no<br /><br>rapid movements of camera relative to anatomy of interest; no change in<br /><br>distance from camera to anatomy of interest. Good SNR defined as: change in<br /><br>fluorescent (ICG) intensity following each ICG bolus is larger than 5x the<br /><br>noise level at baseline (before any ICG is injected).</p><br>