Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal

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.

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Key information

Conditions

Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Caen University Hospital

Caen, Calvados, 14000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Relationship between the Maximum NIRS difference before and during the femoral artery clamping and the increase of walking perimeter

Time frame: Change - One month, six months and one year after the surgery

Sponsors and collaborators

Lead sponsor

University Hospital, Caen

Other

Registry information

Acronym: TEA-NIRS

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Jan 14, 2015
Registry last updated: Jul 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.