Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
Completed
- Conditions
- Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy
- Registration Number
- NCT02337920
- Lead Sponsor
- University Hospital, Caen
- Brief Summary
Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need complementary stenting of revascularization procedures within the 2 years after the primary surgery because of a poor blood supply in their lower limb extremity. The Near infrared spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and provide information on the quality of the local oxygen supply. The aim of our observational study is to correlate the intraoperative NIRS variations at the calf and the soles and the one-year evolution of the arteritis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 31
Inclusion Criteria
- Patients undergoing unilateral femoral endarteriectomy
Exclusion Criteria
- emergency surgery, allergy to adhesive glues, skin abnormalities of the operated leg, multiple associated revascularization procedures other than endarteriectomy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter Change - One month, six months and one year after the surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Caen University Hospital
🇫🇷Caen, Calvados, France