CArbon dioxide surgical field flooding and aortic NO-touch off-pump coronary artery bypass grafting to reduce Neurological injuries after surgical coronary revascularisation (CANON): protocol for a randomised, controlled, investigator and patient blinded single-centre superiority trial with three parallel arms

Szwed Krzysztof, Pawliszak Wojciech, Serafin Zbigniew, Kowalewski Mariusz, Tomczyk Remigiusz, Perlinski Damian, Szwed Magdalena, Tomaszewska Marta, Anisimowicz Lech, Borkowska Alina, Szwed Krzysztof, Pawliszak Wojciech, Serafin Zbigniew, Kowalewski Mariusz, Tomczyk Remigiusz, Perlinski Damian, Szwed Magdalena, Tomaszewska Marta, Anisimowicz Lech, Borkowska Alina

Abstract

Introduction: Neurological injuries remain a major concern following coronary artery bypass grafting (CABG) that offsets survival benefit of CABG over percutaneous coronary interventions. Among numerous efforts to combat this issue is the development of off-pump CABG (OPCABG) that obviates the need for extracorporeal circulation and is associated with improved neurological 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.

Methods and analysis: In this randomised, controlled, investigator and patient blinded single-centre 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 arms and one control arm. Treatment arms undergoing either aortic no-touch OPCABG or OPCABG with partial clamp applying carbon dioxide surgical field flooding will be compared against control arm undergoing OPCABG with partial clamp. The primary endpoint will be the appearance of new lesions on control brain MRI 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.

Ethics and dissemination: Ethical approval has been granted for this study. Results will be disseminated through peer-reviewed media.

Trial registration number: NCT03074604; Pre-results.

Date and version identifier: 10-Mar-2017 Original.

Keywords: Coronary heart disease; Coronary intervention; Delirium & cognitive disorders; Neurological injury; Neuroradiology; Stroke.

Conflict of interest statement

Competing interests: None declared.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

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Figure 1
Single patient diagnostics process.

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