Carbon Dioxide Surgical Field Flooding and Aortic No-touch Off-pump Coronary Artery Bypass Grafting to Reduce Neurological Injuries After Surgical Coronary Revascularization (CANON): a Randomised, Controlled, Investigator and Patient Blinded Single Center Superiority Trial With Three Parallel Arms.

Collegium Medicum w Bydgoszczy

Status: Completed

Conditions: Coronary Artery Disease; Off-Pump Coronary Artery Bypass; Stroke; Neurological Injury; Postoperative Delirium; Coronary Artery Bypass Surgery; Postoperative Cognitive Dysfunction

Treatments: Procedure: aortic no-touch OPCABG; Procedure: OPCABG with partial clamp; Procedure: OPCABG with partial clamp applying carbon dioxide

Study type: Interventional

Funder types: Other

Identifiers

NCT03074604

KB 60/2017

Details and patient eligibility

About

The objective of this study is to investigate the value of employing the aortic no-touch off-pump coronary artery bypass technique and the practice of carbon dioxide surgical field flooding for the prevention of type 1 and 2 neurological injuries following surgical coronary revascularization.

Full description

Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offset survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue, is off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved outcomes. The objective of this study is to examine whether the neuroprotective effect of OPCABG can be further pronounced by the use of two state-of-the-art operating techniques.

In this randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms a total of 360 patients will be recruited. They will be allocated in a 1:1:1 ratio to two treatment and one control arms. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with a partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG. The primary endpoint will be the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery. Secondary endpoints will include the prevalence of new focal neurological deficits in the first 7 days after surgery, the occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery and the incidence of delirium in the first 7 days after surgery. Data will be analysed on intention-to-treat principles and a per protocol basis.

Enrollment: 192 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• elective and/or urgent coronary artery bypass

Exclusion criteria

• emergent and salvage setting
• score below age- and education-adjusted cut-off scores in mini mental state examination
• score above 8 on the subscales of hospital anxiety and depression scale
• neurologic deficit of any etiology
• previous psychiatric illness
• use of tranquilizers or antipsychotics
• alcohol or drug abuse
• history of cardiac surgery
• left ventricular ejection fraction less than 30%
• extracranial carotid artery stenosis of more than 70%
• body mass index of more than 35 kg/m2
• any contraindication for magnetic resonance imaging (e.g., magnetic resonance imaging - incompatible implantable device and claustrophobia)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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192 participants in 3 patient groups

aortic no-touch OPCABG

Experimental group

Description:

aortic no-touch OPCABG

Treatment:

Procedure: aortic no-touch OPCABG

OPCABG with partial clamp applying carbon dioxide

Experimental group

Description:

OPCABG with partial clamp applying carbon dioxide

Treatment:

Procedure: OPCABG with partial clamp applying carbon dioxide

OPCABG with partial clamp

Active Comparator group

Description:

OPCABG with partial clamp

Treatment:

Procedure: OPCABG with partial clamp