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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| aortic no-touch OPCABG | Experimental | aortic no-touch OPCABG |
|
| OPCABG with partial clamp applying carbon dioxide | Experimental | OPCABG with partial clamp applying carbon dioxide |
|
| OPCABG with partial clamp | Active Comparator | OPCABG with partial clamp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aortic no-touch OPCABG | Procedure | (Study arm 1) In this intervention only the internal mammary artery grafts will be used (i.e. left internal mammary artery graft, right internal mammary artery graft, or a Y-graft that uses right internal mammary artery graft anastomosed onto left internal mammary artery graft to allow for a wide territory of myocardial revascularization). However, in the rare event that the aforementioned approach is insufficient to reach all target vessels, a reversed (great) saphenous vein graft may be used to extend the left internal mammary artery graft or the right internal mammary artery graft. |
| Measure | Description | Time Frame |
|---|---|---|
| New lesions on control brain magnetic resonance imaging. | Appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery. | 3 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| New focal neurological deficits. | Prevalence of new focal neurological deficits in the first 7 days after surgery. | 7 days after surgery |
| Occurence of postoperative cognitive dysfunction | Occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Krzysztof Szwed, M.D. Ph.D. | Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland | Principal Investigator |
| Alina Borkowska, Professor | Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | 85-001 | Poland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28698347 | Derived | Krzysztof S, Wojciech P, Zbigniew S, Mariusz K, Remigiusz T, Damian P, Magdalena S, Marta T, Lech A, Alina B. 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. BMJ Open. 2017 Jul 10;7(7):e016785. doi: 10.1136/bmjopen-2017-016785. |
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The data that support the findings of this study are available from the corresponding author upon reasonable request.
Available without time limits.
The data that support the findings of this study are available from the corresponding author upon reasonable request.
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The CANON trial is designed as a randomised, controlled, investigator and patient blinded single center superiority trial with three parallel arms and a primary endpoint being the appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
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| OPCABG with partial clamp applying carbon dioxide | Procedure | (Study arm 2) In this intervention chest cavity will be insufflated with carbon dioxide at a flow above 5 l/min during the entire surgical procedure. |
|
| OPCABG with partial clamp | Procedure | (Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp. |
|
| 1 week or 3 months after surgery |
| Incidence of delirium | Incidence of delirium in the first 7 days after surgery. | 7 days after surgery |
| ID | Term |
|---|---|
| D020196 | Trauma, Nervous System |
| D020521 | Stroke |
| D000079690 | Postoperative Cognitive Complications |
| D000071257 | Emergence Delirium |
| D003324 | Coronary Artery Disease |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D006259 | Craniocerebral Trauma |
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