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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.

NCT03074604 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 192

Last updated 2020-02-05

No results posted yet for this study

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.

Conditions

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

Interventions

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.

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.

PROCEDURE

OPCABG with partial clamp

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

Sponsors & Collaborators

  • Collegium Medicum w Bydgoszczy

    lead OTHER

Principal Investigators

  • Krzysztof Szwed, M.D. Ph.D. · Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland

  • Alina Borkowska, Professor · Department of Clinical Neuropsychology, Nicolaus Copernicus University, Collegium Medicum, Poland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2018-07-01
Completion
2018-07-01

Countries

  • Poland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074604 on ClinicalTrials.gov