Introducing Laser Speckle contrast imaging in the hybrid operating theatre in patients with PAOD
- Conditions
- peripheral arterial occlusive disease
- Registration Number
- NL-OMON23881
- Lead Sponsor
- Medisch Spectrum Twente
- Brief Summary
ot applicable
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 30
Inclusion Criteria
Patients with end stage PAOD (Rutherford CLI grade 4-5-6)
- First/initial intervention for PAOD
Exclusion Criteria
- Re-interventions for PAOD
- Amputation (partial) of foot or toes in medical history
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to analyse whether LSCI could be integrated in a PAOD endovascular operation program in a HOT, for the visualisation of the foot microcirculation. <br /><br>If LSCI could be integrated, the primary objective will be extended to determine a correlation between LSCI outcome values and clinical outcome after an endovascular procedure in patients with PAOD.<br><br>
- Secondary Outcome Measures
Name Time Method Secondary Objective(s): <br /><br>- Inter-subject reproducibility for LSCI <br /><br>- Stability/continuity of the measurements, influences of movement artefacts <br /><br>- Influence of general anaesthesia on measurement outcome values <br /><br>- Analyse if there is a drift/arise of a system error, in the measurements during long measurements (>1 hour) <br /><br> oEnvironmental origin (e.g. temperature) <br /><br> oSystem induced drift<br>