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

Tissue Oxygen Saturation Clinical Trial

— NIRSFEM  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038062
• Other study ID #: Fudickar7
• Status: Completed
• Phase: N/A
• First received: January 14, 2014
• Last updated: November 27, 2016
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: November 2016
• Source: University of Schleswig-Holstein
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:vascular surgery with clamping of a femoral artery. -

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Tissue Oxygen Saturation

Intervention

Procedure:
• Sevoflurane preconditioning
Preconditioning by transient application of sevoflurane

Locations

Country	Name	City	State
Germany	University Hospital Schleswig-Holstein, Campus Kiel	Kiel	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
University of Schleswig-Holstein

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decrease of tissue oxygen saturation below 95 % of baseline	Decrease of tissue oxygen saturation below 95 % of baseline	4 hours	No