Cannulation of the Artery Axiliaris for Extracorporeal Circulation

Not Applicable

• Conditions: Neurologic Manifestations
• Interventions: Procedure: cannulation

• Registration Number: NCT01615172
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

Comparision of two different cannulation techniques on the neurological outcome in cardiac surcical procedures. Study hypothesis: Cannulation of the axilaris artery can reduce neurolocical side effects.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-06-04
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-08
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-06
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Cardiac procedure with ecc Age 40-85 years CABG and/or valve

Exclusion Criteria

• Stenosis of a.subclavia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
axilaris cannulation	cannulation	new type of cannulation
Aortic cannulation	cannulation	routine placement of aortic cannula

Primary Outcome Measures

Name	Time	Method
Surrogat endpoint: Number of participants with change from baseline in Neurolocial events at 5th postoperative day (POD) and 3 month after operation	Participants will be followed for the duration of hospital stay (5 POD) and a follow up visit 3 months after discharge	Neurological events were detected by:NIRO (Near-infrared spectroscopy), EEG (Electrencenphalographie), MRI (Magnet resonance imaging) and test battery (Mini mental status test, HAWIE-R)

Trial Locations

Locations (1)

Goethe Universität; 🇩🇪 Frankfurt, Hessen, Germany