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.

Stroke Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074604
• Other study ID #: KB 60/2017
• Status: Completed
• Phase: N/A
• Start date: February 28, 2017
• Est. completion date: July 1, 2018

Study information

• Verified date: February 2020
• Source: Collegium Medicum w Bydgoszczy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 192
• Est. completion date: July 1, 2018
• Est. primary completion date: July 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Coronary Artery Bypass Surgery
• Coronary Artery Disease
• Coronary Disease
• Delirium
• Myocardial Ischemia
• Neurological Injury
• Off-Pump Coronary Artery Bypass
• Postoperative Cognitive Dysfunction
• Postoperative Delirium
• Stroke
• Trauma, Nervous System
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Poland	Department of Cardiac Surgery, Dr Antoni Jurasz Memorial University Hospital	Bydgoszcz	Kujawsko-Pomorskie

Sponsors (1)

Lead Sponsor	Collaborator
Collegium Medicum w Bydgoszczy

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	New focal neurological deficits.	Prevalence of new focal neurological deficits in the first 7 days after surgery.	7 days after surgery
Secondary	Occurence of postoperative cognitive dysfunction	Occurrence of postoperative cognitive dysfunction at either 1 week or 3 months after surgery	1 week or 3 months after surgery
Secondary	Incidence of delirium	Incidence of delirium in the first 7 days after surgery.	7 days after surgery