Comparison sleep quality of patients after coronary artery bypass grafting by pulsatile flow and non-pulsatile flow in cardiopulmonary bypass
Design
Double blinded clinical trial with control group that has two parallel groups with sample size of 47 persons.
Settings and conduct
Patients that referred to Isfahan Chamran Hospital who were included in the study were randomly divided into two groups. Patients in the intervention group during aortic cross clamp gave pulsatile blood flow. Pittsburgh sleep quality questionnaire was completed before and one month after surgery by rater.This study was double_blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients under CABG surgery, Patient consent, The BMI of less than 35, The age of less than 70 years and ability to respond correctly to the questionnaire.
Exclusion criteria: History of any stroke, Poor sleep quality before surgery, Chronic consumption of alcohol and antidepressants.
Intervention groups
26 patients were under pulsatile flow during aortic clamp.
Main outcome variables
Sleep quality score based on PSQI questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190807044469N1
Registration date:2020-01-12, 1398/10/22
Registration timing:retrospective
Last update:2020-01-12, 1398/10/22
Update count:0
Registration date
2020-01-12, 1398/10/22
Registrant information
Name
Nahid Jahannama
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5364 3792
Email address
jahannama@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-31, 1398/05/09
Expected recruitment end date
2019-11-19, 1398/08/28
Actual recruitment start date
2019-07-31, 1398/05/09
Actual recruitment end date
2019-11-20, 1398/08/29
Trial completion date
2019-12-20, 1398/09/29
Scientific title
Comparing sleep quality of patients after coronary artery bypass grafting by pulsatile flow and non-pulsatile flow in cardiopulmonary bypass
Public title
The effect of pulsatile flow on sleep quality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
History of any stroke
Poor sleep quality before surgery
Chronic consumption of alcohol and antidepressants
Age
To 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
50
Actual sample size reached:
47
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method is a simple Non-probability and randomization using SPSS software
Blinding (investigator's opinion)
Double blinded
Blinding description
Each participant is numbered randomly using SPSS software. The patient and the rater are unaware of the type of procedure.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Approval date
2019-07-31, 1398/05/09
Ethics committee reference number
IR.MUI.MED.REC.1398.235
Health conditions studied
1
Description of health condition studied
Sleep Quality
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Sleep quality
Timepoint
Before and one month after surgery
Method of measurement
Pittsburgh Sleep Quality Index
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
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
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran Hospital
Full name of responsible person
Nahid Jahannama
Street address
Chamran Hospital, Salman Farsi st.
City
Isfahan
Province
Isfehan
Postal code
81661-73414
Phone
+98 31 3260 0961
Email
jahannama@resident.mui.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Vice-Chancellor for Research and Technology - Isfahan University of Medical Sciences
Street address
Hezar Jerib
City
Isfahan
Province
Isfehan
Postal code
73461-81746
Phone
+98 31 3792 9096
Email
research@mui.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac Surgery
Street address
Chamran Hospital, Salman Farsi st.
City
Isfahan
Province
Isfehan
Postal code
81661-73414
Phone
+98 31 3260 0961
Email
am_sadeghi@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac Surgery
Street address
Chamran Hospital, Salman Farsi st.
City
Isfahan
Province
Isfehan
Postal code
81661-73414
Phone
+98 31 3260 0961
Email
am_sadeghi@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiac Surgery
Street address
Chamran Hospital, Salman Farsi st.
City
isfahan
Province
Isfehan
Postal code
81661-73414
Phone
+98 31 3260 0961
Email
am_sadeghi@med.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Because of secondary data analyze
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available