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.
CANON
1 other identifier
interventional
192
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2017
CompletedStudy Start
First participant enrolled
February 28, 2017
CompletedFirst Posted
Study publicly available on registry
March 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFebruary 5, 2020
February 1, 2020
1.3 years
February 28, 2017
February 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Incidence of delirium
7 days after surgery
Study Arms (3)
aortic no-touch OPCABG
EXPERIMENTALaortic no-touch OPCABG
OPCABG with partial clamp applying carbon dioxide
EXPERIMENTALOPCABG with partial clamp applying carbon dioxide
OPCABG with partial clamp
ACTIVE COMPARATOROPCABG with partial clamp
Interventions
(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.
(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.
(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp.
Eligibility Criteria
You may qualify if:
- elective and/or urgent coronary artery bypass
You may not qualify if:
- 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.
Sponsors & Collaborators
Study Sites (1)
Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-001, Poland
Related Publications (1)
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.
PMID: 28698347DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Krzysztof Szwed, M.D. Ph.D.
Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
- STUDY CHAIR
Alina Borkowska, Professor
Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
February 28, 2017
First Posted
March 9, 2017
Study Start
February 28, 2017
Primary Completion
July 1, 2018
Study Completion
July 1, 2018
Last Updated
February 5, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share
- 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.
The data that support the findings of this study are available from the corresponding author upon reasonable request.