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IRCT20190807044469N1 IRCT 2020-01-12 Esfahan University of Medical Sciences The effect of pulsatile flow on sleep quality Comparing sleep quality of patients after coronary artery bypass grafting by pulsatile flow and non-pulsatile flow in cardiopulmonary bypass 2019-07-31 anticipated 50 Complete https://irct.ir/trial/42050 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Sampling method is a simple Non-probability and randomization using SPSS software, Blinding description: Each participant is numbered randomly using SPSS software. The patient and the rater are unaware of the type of procedure. N/A Sleep Quality. Intervention 1: Intervention group: Pittsburgh questionnaire was completed two days before and a month after surgery. The same methods for anesthesia and surgery, heart-lung machine, oxygenator, arterial filter and cannula was used for all patients. During surgery, body temperature of patients was reduced to 34 celsius degrees and the mean arterial pressure was kept between 80-90 mmHg. After the clamping aorta and injection of cardioplegia and heart arrest, patients of intervention group were under pulsatile blood flow during clamping aortic. Intervention 2: Control group: All condition are the same as the intervention group except that patients were under non pulsatile blood flow in all the time CPB. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of secondary data analyze
public Amir Mirmohammadsadeghi
Chamran Hospital, Salman Farsi st.
Isfahan Iran (Islamic Republic of) 81661-73414 +98 31 3260 0961 am_sadeghi@med.mui.ac.ir Esfahan University of Medical Sciences scientific Amir Mirmohammadsadeghi
Chamran Hospital, Salman Farsi st.
Isfahan Iran (Islamic Republic of) 81661-73414 +98 31 3260 0961 am_sadeghi@med.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients under CABG surgery Patient consent The age of less than 70 years The BMI of less than 35 Ability to respond correctly to the questionnaire no limit 70 years Both History of any stroke Poor sleep quality before surgery Chronic consumption of alcohol and antidepressants Treatment - Surgery Treatment - Surgery Intervention group: Pittsburgh questionnaire was completed two days before and a month after surgery. The same methods for anesthesia and surgery, heart-lung machine, oxygenator, arterial filter and cannula was used for all patients. During surgery, body temperature of patients was reduced to 34 celsius degrees and the mean arterial pressure was kept between 80-90 mmHg. After the clamping aorta and injection of cardioplegia and heart arrest, patients of intervention group were under pulsatile blood flow during clamping aortic. Control group: All condition are the same as the intervention group except that patients were under non pulsatile blood flow in all the time CPB Sleep quality. Timepoint: Before and one month after surgery. Method of measurement: Pittsburgh Sleep Quality Index. Esfahan University of Medical Sciences Approved 2019-07-31 Ethics committee of Isfahan University of Medical Sciences Hezar Jerib Isfahan Isfehan Iran (Islamic Republic of)