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

Sponsor
University Hospital, Caen (Other)
Overall Status
Completed
CT.gov ID
NCT02337920
Collaborator
(none)
31
Enrollment
1
Location
12
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    31 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
    Actual Study Start Date :
    Feb 1, 2015
    Actual Primary Completion Date :
    Feb 1, 2016
    Actual Study Completion Date :
    Feb 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Caen University Hospital Caen Calvados France 14000

    Sponsors and Collaborators

    • University Hospital, Caen

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Caen
    ClinicalTrials.gov Identifier:
    NCT02337920
    Other Study ID Numbers:
    • TEA-NIRS
    First Posted:
    Jan 14, 2015
    Last Update Posted:
    Jul 21, 2017
    Last Verified:
    Jul 1, 2015

    Study Results

    No Results Posted as of Jul 21, 2017