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.
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.
Registry Overview
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Recruitment status
completed
Actual enrollment (reported)
192 participants
Study completion date
July 1, 2018
Actual (reported)
Listed locations
1 countries · 1 sites
Trial Relationships
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Study Timeline
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
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
Secondary Outcomes (3)
New focal neurological deficits.
7 days after surgery
Occurence of postoperative cognitive dysfunction
1 week or 3 months after surgery
Study Arms (3)
aortic no-touch OPCABG
EXPERIMENTAL
aortic no-touch OPCABG
Procedure: aortic no-touch OPCABG
OPCABG with partial clamp applying carbon dioxide
EXPERIMENTAL
OPCABG with partial clamp applying carbon dioxide
Procedure: OPCABG with partial clamp applying carbon dioxide
OPCABG with partial clamp
ACTIVE COMPARATOR
OPCABG with partial clamp
Procedure: OPCABG with partial clamp
Interventions
aortic no-touch OPCABGProcedure
(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.
aortic no-touch OPCABG
OPCABG with partial clamp applying carbon dioxideProcedure
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.
Nervous System DiseasesWounds and InjuriesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesPostoperative ComplicationsPathologic Processes
Study Officials
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
Enrollment
192 participants (actual enrollment reported by the registry).
Study Design
Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
(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 applying carbon dioxide
OPCABG with partial clampProcedure
(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp.
OPCABG with partial clamp
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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)
Contact the study team to confirm eligibility.
Pathological Conditions, Signs and Symptoms
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Coronary Disease
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Craniocerebral Trauma
Study Start
February 28, 2017
Actual (reported)
Primary Completion
July 1, 2018
Actual (reported)
Study Completion
July 1, 2018
Actual (reported)
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
IPD Sharing
Will share
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Shared Documents
STUDY PROTOCOL, CSR
Time Frame
Available without time limits.
Access Criteria
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Source record
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Source: ClinicalTrials.gov.
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