The Fusion Versus The Affinity Oxygenation Systems

Hadassah Medical Center

Status: Unknown

Conditions: Complication of Coronary Artery Bypass Graft

Treatments: Device: Affinity oxygenation system; Device: fusion oxygenation system

Study type: Interventional

Funder types: Other

Identifiers

NCT02554305

0033-15-HMO

Details and patient eligibility

About

This study compares between the clinical, hematological, inflammatory and neurological outcome of patients undergoing Coronary Artery Bypass Grafting (CABG) surgery in which different oxygenation systems will be used.

Full description

In order to assess the efficacy and safety of fusion Oxygenation System in patients undergoing isolated CABG, a prospective one-to-one randomized trial comparing the fusion oxygenation to the currently used affinity oxygenation system will be conducted. Forty patients intending to undergo CABG will be divided into 2 groups according to the oxygenation system which will be used during surgery. Distribution into groups will be done randomly. Ten patients undergoing elective peripheral vascular surgical procedures under general anesthesia and 10 patients undergoing elective percutaneous coronary intervention will serve as control groups for the neurological outcomes. Clinical status, inflammatory and hematological response as well as Neurological outcome will be assessed.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients (18-75 years old) undergoing first-time, isolated CABG at the Hebrew University, Hadassah Medical Center, Jerusalem, Israel and the University Hospital of Angers, Angers, France.
• Patients undergoing elective peripheral vascular surgical procedures under general anesthesia
• Patients undergoing elective percutaneous coronary intervention will serve as control groups

Exclusion criteria

• Emergency operations
• Left ventricular ejection fraction less than 30%
• CABG with concomitant procedure
• Previous stroke or documented neurological disorder
• High grade (>70%) unilateral or bilateral carotid stenosis
• Contraindication to MRI testing.

Trial design

60 participants in 4 patient groups

Fusion oxygenation system

Active Comparator group

Description:

Fusion oxygenation machine will be used during the operation.

Treatment:

Device: fusion oxygenation system

Affinity oxygenation system

Active Comparator group

Description:

Affinity oxygenation machine will be used during the operation.

Treatment:

Device: Affinity oxygenation system

Peripheral vascular procedure

No Intervention group

Description:

No oxygenation machine will be used in this group

percutaneous coronary intervention

No Intervention group

Description:

No oxygenation machine will be used in this group