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Completed

NCT Number: NCT02038062

Tissue Oxygenation of the Tibial Anterior Muscle After Clamping of the Femoral Artery

Ischemic preconditioning is defined as protection from cell damage induced by prolonged ischemia by preceding cycles of short ischemia. Hence, ischemic preconditioning could reduce ischemic lesion during clamping a femoral artery for vascular surgery. In this prospective, randomized pilot study is investigated if clamping of the femoral artery leads to ischemia of the calf measurable by near-infrared spectroscopy. In addition to this, the effect of sevoflurane preconditioning on ischemia of the calf is measured.

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Key information

Conditions

Tissue Oxygen Saturation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

About this study

Ischemic preconditioning is performed by clamping of the femoral artery for five minutes in 40 patients. In 20 patients sevoflurane preconditioning is performed five minutes before ischemic preconditioning by inducing sevoflurane anesthesia for five minutes. Muscle tissue oxygenation is measured bilaterally in the anterior tibial muscle by near-infrared spectroscopy (INVOS, SOMANETICS, Troy, Michigan/ USA) during preconditioning and following ischemia.Clinically relevant ischemia was defined as a decrease of tissue oxygen saturation to 95 % of baseline.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

vascular surgery with clamping of a femoral artery. -

Exclusion criteria

-

Treatment and study plan

Sevoflurane preconditioning

Procedure

Preconditioning by transient application of sevoflurane

Primary outcomes

  1. Decrease of tissue oxygen saturation below 95 % of baseline

    Time frame: 4 hours

    Decrease of tissue oxygen saturation below 95 % of baseline

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

Influence of Sevoflurane Preconditioning on Tissue Oxygenation of the Tibial Anterior Muscle Measured by Near-infrared Spectroscopy After Clamping of the Femoral Artery for Vascular Surgery

Acronym: NIRSFEM

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jan 16, 2014
Registry last updated
Nov 29, 2016

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

View the official ClinicalTrials.gov record (opens in a new tab)

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.

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