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IRCT20170620034666N4 IRCT 2022-01-30 Esfahan University of Medical Sciences Comparative study of pulsatile and non-pulsatile blood flow on cerebral oximetry in patients with different intensities of carotid stenosis and without stenosis Comparative study of pulsatile and non-pulsatile blood flow on cerebral oximetry in patients with different intensities of carotid stenosis and without stenosis during coronary artery bypass graft (CABG) 2021-11-22 anticipated 61 Complete https://irct.ir/trial/60277 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment. N/A Coronary artery bypass graft. Intervention 1: Intervention group: Nonpulsatil blood flow: From the start of cardiopulmonary bypass during CABG surgery, the blood flow carried by the cardiopulmonary bypass machine to the body will be nonpulsatil mode in all participants and their cerebral oxygen saturation will be recorded by the near-infrared spectroscopy (NIRS) device leads. Intervention 2: Intervention group: Pusatil blood flo: After some times of aortic cross clamping during surgery (15-20 minutes after the start of aortic cross clamping) we will change the blood flow from nonpulsatil (linear) to pulsatile blood flow for 15 minutes by cardiopulmonary bypass machine in all participants and its effects on cerebral oxygen saturation will be recorded during this 15 minutes by the leads of the Near Infrared Spectroscopy (NIRS). Yes - There is a plan to make this available What will be shared: After finishing the study the data will be available When: After publishing the article To whom: Faculty members Conditions: Contacting the scientist responsible by email causes the data to be used in order to use the data in scientific research such as meta analysis or secondary analysis Where to obtain: Scientific responsible can provide the study data to academic researchers without the name of individuals. Scientific responsible: Dr.mehran shahzamani. Address: Isfahan. Moshtagh Ave, chanran heart center. postal code: (8174673461). Call number: (+98 31 3670 1227). Mobile phone number: (+98 913 123 1453). Email: m.shahzamani@med.mui.ac.ir How to obtain: Just forwarding email to scientific responsible of this trial is enough. Email address: m.shahzamani@med.mui.ac.ir (Will be answered within a month.) Comments:
public Mehran Shahzamani
Isfahan, Hezarjarib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3670 1227 m.shahzamani@med.mui.ac.ir Esfahan University of Medical Sciences scientific مهران شاهزمانی
Isfahan, Hezarjarib Ave
Isfahan Iran (Islamic Republic of) 8174673461 +98 913 123 1453 m.shahzamani@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Elective CABG surgery patients With carotid stenosis below 70% and without carotid stenosis no limit no limit Both Recent stroke Vertebral artery stenosis I25.1 Atherosclerotic heart disease of native coronary artery Treatment - Surgery Treatment - Surgery Intervention group: Nonpulsatil blood flow: From the start of cardiopulmonary bypass during CABG surgery, the blood flow carried by the cardiopulmonary bypass machine to the body will be nonpulsatil mode in all participants and their cerebral oxygen saturation will be recorded by the near-infrared spectroscopy (NIRS) device leads. Intervention group: Pusatil blood flo: After some times of aortic cross clamping during surgery (15-20 minutes after the start of aortic cross clamping) we will change the blood flow from nonpulsatil (linear) to pulsatile blood flow for 15 minutes by cardiopulmonary bypass machine in all participants and its effects on cerebral oxygen saturation will be recorded during this 15 minutes by the leads of the Near Infrared Spectroscopy (NIRS). Cerebral oximetry. Timepoint: After aortic cross clamp, immediately before the start of the pulsatile blood flow, 15 minutes after the start of the pulsatile flow (end of the pulsatile flow) and after returning to the non-pulsatile flow. Method of measurement: By near infrared spectroscopy device monitor. Esfahan University of Medical Sciences Approved 2021-11-22 Ethics committee of Isfahan University of Medical Sciences Hezarjarib Ave, Isfahan University of Medical Sciences Isfahan Isfehan Iran (Islamic Republic of)