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)
Primary Purpose
Neurological Injury, Stroke, Postoperative Cognitive Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
aortic no-touch OPCABG
OPCABG with partial clamp applying carbon dioxide
OPCABG with partial clamp
Sponsored by
About this trial
This is an interventional treatment trial for Neurological Injury focused on measuring Brain Injuries, Neurological Injury, Stroke, Postoperative Cognitive Dysfunction, Postoperative Delirium, Coronary Artery Disease, Coronary Artery Bypass Grafting, Coronary Artery Bypass Surgery, Bypass surgery, Beating Heart Coronary Artery Bypass, Off-Pump Coronary Artery Bypass
Eligibility Criteria
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)
Sites / Locations
- Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
aortic no-touch OPCABG
OPCABG with partial clamp applying carbon dioxide
OPCABG with partial clamp
Arm Description
aortic no-touch OPCABG
OPCABG with partial clamp applying carbon dioxide
OPCABG with partial clamp
Outcomes
Primary Outcome Measures
New lesions on control brain magnetic resonance imaging.
Appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
Secondary Outcome Measures
New focal neurological deficits.
Prevalence of new focal neurological deficits in the first 7 days after surgery.
Occurence of postoperative cognitive dysfunction
Occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery
Incidence of delirium
Incidence of delirium in the first 7 days after surgery.
Full Information
NCT ID
NCT03074604
First Posted
February 28, 2017
Last Updated
February 3, 2020
Sponsor
Collegium Medicum w Bydgoszczy
1. Study Identification
Unique Protocol Identification Number
NCT03074604
Brief Title
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.
Acronym
CANON
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
February 28, 2017 (Actual)
Primary Completion Date
July 1, 2018 (Actual)
Study Completion Date
July 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Collegium Medicum w Bydgoszczy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurological Injury, Stroke, Postoperative Cognitive Dysfunction, Postoperative Delirium, Coronary Artery Disease, Coronary Artery Bypass Surgery, Off-Pump Coronary Artery Bypass
Keywords
Brain Injuries, Neurological Injury, Stroke, Postoperative Cognitive Dysfunction, Postoperative Delirium, Coronary Artery Disease, Coronary Artery Bypass Grafting, Coronary Artery Bypass Surgery, Bypass surgery, Beating Heart Coronary Artery Bypass, Off-Pump Coronary Artery Bypass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
192 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aortic no-touch OPCABG
Arm Type
Experimental
Arm Description
aortic no-touch OPCABG
Arm Title
OPCABG with partial clamp applying carbon dioxide
Arm Type
Experimental
Arm Description
OPCABG with partial clamp applying carbon dioxide
Arm Title
OPCABG with partial clamp
Arm Type
Active Comparator
Arm Description
OPCABG with partial clamp
Intervention Type
Procedure
Intervention Name(s)
aortic no-touch OPCABG
Intervention Description
(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.
Intervention Type
Procedure
Intervention Name(s)
OPCABG with partial clamp applying carbon dioxide
Intervention Description
(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.
Intervention Type
Procedure
Intervention Name(s)
OPCABG with partial clamp
Intervention Description
(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp.
Primary Outcome Measure Information:
Title
New lesions on control brain magnetic resonance imaging.
Description
Appearance of new lesions on control brain magnetic resonance imaging 3 days after surgery.
Time Frame
3 days after surgery
Secondary Outcome Measure Information:
Title
New focal neurological deficits.
Description
Prevalence of new focal neurological deficits in the first 7 days after surgery.
Time Frame
7 days after surgery
Title
Occurence of postoperative cognitive dysfunction
Description
Occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery
Time Frame
1 week or 3 months after surgery
Title
Incidence of delirium
Description
Incidence of delirium in the first 7 days after surgery.
Time Frame
7 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Krzysztof Szwed, M.D. Ph.D.
Organizational Affiliation
Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alina Borkowska, Professor
Organizational Affiliation
Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital
City
Bydgoszcz
State/Province
Kujawsko-Pomorskie
ZIP/Postal Code
85-001
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study are available from the corresponding author upon reasonable request.
IPD Sharing Time Frame
Available without time limits.
IPD Sharing Access Criteria
The data that support the findings of this study are available from the corresponding author upon reasonable request.
Citations:
PubMed Identifier
28698347
Citation
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.
Results Reference
derived
Learn more about this trial
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.
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