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.

NCT ID: NCT03074604

Last Updated: 2020-02-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 192 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-28
• Study Completion Date: 2018-07-01

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.

Conditions

Neurological Injury; Stroke; Postoperative Cognitive Dysfunction; Postoperative Delirium; Coronary Artery Disease; Coronary Artery Bypass Surgery; Off-Pump Coronary Artery Bypass

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

aortic no-touch OPCABG

aortic no-touch OPCABG

Group Type: EXPERIMENTAL

aortic no-touch OPCABG

Intervention Type: 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.

OPCABG with partial clamp applying carbon dioxide

OPCABG with partial clamp applying carbon dioxide

Group Type: EXPERIMENTAL

OPCABG with partial clamp applying carbon dioxide

Intervention Type: 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

OPCABG with partial clamp

Group Type: ACTIVE_COMPARATOR

OPCABG with partial clamp

Intervention Type: PROCEDURE

(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp.

Interventions

aortic no-touch OPCABG

(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

OPCABG with partial clamp applying carbon dioxide

(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

OPCABG with partial clamp

(Study arm 3) This is the control arm undergoing "traditional" OPCABG with partial clamp.

Intervention Type: PROCEDURE

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)

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Collegium Medicum w Bydgoszczy

OTHER

Sponsor Role: lead

Responsible Party

Krzysztof Szwed

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Krzysztof Szwed, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland

Alina Borkowska, Professor

Role: STUDY_CHAIR

Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland

Locations

Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 28698347 (View on PubMed)

Other Identifiers

KB 60/2017

Identifier Type: -

Identifier Source: org_study_id