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

NCT ID: NCT02038062

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tissue Oxygen Saturation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Sevoflurane

Sevoflurane Preconditioning

Group Type EXPERIMENTAL

Sevoflurane preconditioning

Intervention Type PROCEDURE

Preconditioning by transient application of sevoflurane

No Sevoflurane

No Sevoflurane Preconditioning

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sevoflurane preconditioning

Preconditioning by transient application of sevoflurane

Intervention Type PROCEDURE

Eligibility Criteria

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Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Schleswig-Holstein

OTHER

Sponsor Role lead

Responsible Party

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Axel Fudickar

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Axel Fudickar, Dr.

Role: PRINCIPAL_INVESTIGATOR

University Hospital Schleswig-Holstein

Locations

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University Hospital Schleswig-Holstein, Campus Kiel

Kiel, Schleswig-Holstein, Germany

Site Status

Countries

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Germany

References

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Fudickar A, Kunath S, Voss D, Siggelkow M, Cavus E, Steinfath M, Bein B. Effect of ischemic and pharmacological preconditioning of lower limb muscle tissue on tissue oxygenation measured by near-infrared spectroscopy--a pilot study. BMC Anesthesiol. 2014 Jul 15;14:54. doi: 10.1186/1471-2253-14-54. eCollection 2014.

Reference Type DERIVED
PMID: 25132803 (View on PubMed)

Other Identifiers

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Fudickar7

Identifier Type: -

Identifier Source: org_study_id