Evaluation of the effect of Remote Ischemic Pre Conditioning on post operative atrial fibrillation in patients undergoing coronary artery bypass graft surgery
Evaluation of the effect of Remote Ischemic Pre Conditioning on post operative atrial fibrillation in patients undergoing coronary artery bypass graft surgery
Design
A randomized clinical trial without control group, with parallel groups, without blindness that, 80 patients randomly divided into two groups of 40 subjects with block sizes of 4 and 6.
Settings and conduct
The study population was patients aged 40-80 years referred to Ayatollah Rouhani Hospital in Babol. Patients were randomly divided into two intervention groups using a random number table and the free website WWW.randomization .com.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with coronary artery disease are candidates for coronary artery bypass grafting
Exclusion Criteria: Chronic lung disease, Liver disease, kidney disease, Emergency surgery and Thyroid diseases
Intervention groups
Intervention group: The pressure indicator cuff closes around the right arm. The pressure indicator cuff is filled alternately in three shifts of 5 minutes up to 200 mm Hg, which are separated by 5-minute rest intervals, during which the cuff breaks completely.
Control group: The pressure indicator cuff is closed around the right arm. The pressure indicator cuff is never filled and only closes around the right arm for 30 minutes.
Main outcome variables
Atrial fibrillation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20101213005381N14
Registration date:2021-03-07, 1399/12/17
Registration timing:registered_while_recruiting
Last update:2021-03-07, 1399/12/17
Update count:0
Registration date
2021-03-07, 1399/12/17
Registrant information
Name
Nadia Banihashem
Name of organization / entity
Babol University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 22 38296
Email address
nbanihashem@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-08-21, 1400/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of Remote Ischemic Pre Conditioning on post operative atrial fibrillation in patients undergoing coronary artery bypass graft surgery
Public title
Evaluation of postoperative atrial fibrillation in patients with heart surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with coronary artery disease are candidates for coronary artery bypass grafting
The patients randomly divided into two groups of 40 subjects with four and six blocks and an allocation ratio of 1: 1.The free website WWW.randomization .com was used to generate the allocation sequence. The obtained sequence was written on separate sheets and placed in sealed envelopes and given to the main researcher for study.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Babol University Of Medical Sciences
Street address
Daneshgah Square, Ganjafrooz Avenue
City
Babol
Province
Mazandaran
Postal code
47176-41367
Approval date
2020-12-05, 1399/09/15
Ethics committee reference number
IR.MUBABOL.REC.1399.409
Health conditions studied
1
Description of health condition studied
Atrial fibrillation
ICD-10 code
I48
ICD-10 code description
Atrial fibrillation and flutter
Primary outcomes
1
Description
Atrial fibrillation after CABG
Timepoint
From the end of surgery untill 72 hours after surgery
Method of measurement
Heart monitoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The pressure indicator cuff closes around the right arm. The pressure indicator cuff is filled alternately in three shifts of 5 minutes up to 200 mm Hg, which are separated by 5-minute rest intervals, during which the cuff breaks completely.
Category
Diagnosis
2
Description
Control group: The pressure indicator cuff is closed around the right arm. The pressure indicator cuff is never filled and only closes around the right arm for 30 minutes.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Ayatollah Rouhani Hospital
Full name of responsible person
Nadia Banihashem
Street address
Daneshgah Square, Ganjafrooz Avenue, Ruhani Hospital
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3233 8301
Email
n.banihashem@mubabol.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Babol University of Medical Sciences
Full name of responsible person
Reza Ghadimi
Street address
Daneshgah Square, Ganjafrooz Avenue,Vice-chancellor Of Research,
City
Babol
Province
Mazandaran
Postal code
47176-41367
Phone
+98 11 3219 7667
Email
rezaghadimi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?