Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal (TEA-NIRS)

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• France
  • Calvados
    • Caen, Calvados, France, 14000
      • Caen University hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing unilateral femoral endarteriectomy

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Caen
• Investigators: Principal Investigator: Georges Daccache, M.D, University Hospital, Caen

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: November 27, 2014
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): July 21, 2017
• Last Update Submitted That Met QC Criteria: July 19, 2017
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: TEA-NIRS