Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02337920

Acronym

TEA-NIRS

Enrollment

Registered

2015-01-14

Start date

2015-02-28

Completion date

2016-02-29

Last updated

2017-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results