Tissue Oxygenation of the Tibial Anterior Muscle After Cl... | NCT02038062

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

NCT02038062

Sponsor

University Hospital Schleswig-Holstein

Status

Completed

Last Update Posted

Nov 29, 2016Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Tissue Oxygen Saturation

Interventions

Sevoflurane preconditioning

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Jan 14, 2014

First Submission Date that Met QC Criteria

Jan 15, 2014

First Posted Date

Jan 16, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 27, 2016

Last Update Posted Date

Nov 29, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Axel Fudickar, Dr., University Hospital Schleswig-HolsteinPrincipal Investigator

Lead Sponsor

University Hospital Schleswig-HolsteinOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sevoflurane	Experimental	Sevoflurane Preconditioning	Procedure: Sevoflurane preconditioning
No Sevoflurane	No Intervention	No Sevoflurane Preconditioning

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sevoflurane preconditioning	Procedure	Preconditioning by transient application of sevoflurane	Sevoflurane

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decrease of tissue oxygen saturation below 95 % of baseline	Decrease of tissue oxygen saturation below 95 % of baseline	4 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Axel Fudickar, Dr.	University Hospital Schleswig-Holstein	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Schleswig-Holstein, Campus Kiel		Kiel	Schleswig-Holstein	24105	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25132803	Derived	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.