Comparison of effect of 1:1 and 1:2 frequency of Intra-aortic balloon pump on hemodynamic situation in patients with medium dose of inotrope after Coronary Artery Bypass Graft
Comparison of effect of 1:1 and 1:2 frequency of Intra-aortic balloon pump on hemodynamic situation in patients with medium dose of inotrope after Coronary Artery Bypass Graft
Design
quasi-experimental , with pretest - post test, no blinding,
Settings and conduct
Cases are patients who need Intra-aortic balloon pump after coronary artery bypass graft in Isfahan Chamran Heart Hospital, the device is set to 1: 1 frequency and it changes to 1:2 frequency for 20 minutes after reaching a median dose of inotropes, then cardiac parameters are recorded at two frequencies by echocardiography.
Participants/Inclusion and exclusion criteria
Entry Conditions: People who underwent CABG but due to low cardiac output, mean arterial blood pressure less than 80 mmHg failed to separate from the cardiopulmonary pump device and required postoperative IABP.
Patients who are consenting to participate in the project, which will be obtained from the legal guardian if the patient is unconscious.
Non-Entry Conditions: People performing CABG at the same time as aortic valve and arch-related operations such as: aortic valve replacement, Bental surgery, etc.
Intervention groups
This design is a quasi-experimental study of pre-test - posttest that compares all those who were at the 1: 1 frequency before and at the start of the intervention with the 1: 2 frequency step.
Main outcome variables
Cardiac index; Cardiac output; Systolic blood pressure; Diastolic blood pressure; Arterial mean pressure; Heart rate; Integrated aortic blood flow at diastolic time
General information
Reason for update
Acronym
IABP
IRCT registration information
IRCT registration number:IRCT20190922044844N1
Registration date:2020-03-03, 1398/12/13
Registration timing:registered_while_recruiting
Last update:2020-03-03, 1398/12/13
Update count:0
Registration date
2020-03-03, 1398/12/13
Registrant information
Name
Moniresadat Afzali arani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7753 1154
Email address
m.afzali@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-07, 1398/07/15
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of effect of 1:1 and 1:2 frequency of Intra-aortic balloon pump on hemodynamic situation in patients with medium dose of inotrope after Coronary Artery Bypass Graft
Public title
Comparison of effect of two different frequencies of Intra-aortic balloon pump on hemodynamic situation in patients after Coronary Artery Bypass Graft
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People who underwent CABG but due to low cardiac output, mean arterial blood pressure less than 80 mmHg failed to separate from the cardiopulmonary pump device and required postoperative IABP.
Patients who are consenting to participate in the project, which will be obtained from the legal guardian if the patient is unconscious.
Exclusion criteria:
People who perform CABG at the same time as aortic valve and arch operations such as: aortic valve replacement, Bental surgery, etc.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
9
More than 1 sample in each individual
Number of samples in each individual:
2
The hemodynamic parameters defined in the article are first measured in patients with a 1: 1 frequency of the intra-aortic balloon pump and then re-measured in the phase when patients are at a 1: 2 frequency.
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
Unit 24, No. 73, Hoquqi Ave., Somayeh Cross., Shariaty Ave.
City
Tehran
Province
Tehran
Postal code
1611812345
Approval date
2019-07-28, 1398/05/06
Ethics committee reference number
IR.MUI.MED.REC.1398.229
Health conditions studied
1
Description of health condition studied
Influence of 1: 1 and 1: 2 frequency balloon pumps
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The rate of change in the velocity time integral of aortic blood flow during systole
Timepoint
In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again.
Method of measurement
The velocity time integral value of aortic blood flow during systole is measured by echocardiography.
2
Description
The measurement of area left ventricular outflow tract ( area LVOT)
Timepoint
At moderate doses of inotropic drugs, this variable is measured before the intervention begins.
Method of measurement
This variable is measured by echocardiography,
3
Description
Rate of change in systolic blood pressure in patients
Timepoint
In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again.
Method of measurement
it's measured by a built-in arterial line for patients and cardiac monitoring devise
4
Description
Rate of change in diastolic blood pressure in patients
Timepoint
In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again.
Method of measurement
it's measured by a built-in arterial line for patients and cardiac monitoring devise
5
Description
Rate of change in heart rates in patients
Timepoint
In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again.
Method of measurement
it's measured by a cardiac monitoring devise
6
Description
Rate of change in mean arterial blood pressure in patients
Timepoint
In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again.
Method of measurement
it's measured by a built-in arterial line for patients and cardiac monitoring devise
7
Description
The measure of body surface area
Timepoint
At moderate doses of inotropic drugs, this variable is measured before the intervention begins.
Method of measurement
This variable is measured by echocardiography,
8
Description
Rate of change in cardiac output of patients
Timepoint
In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again.
Method of measurement
It will be calculated by the formula and collected required data
9
Description
Rate of change in cardiac index of patients
Timepoint
In average dose of Inotropes, this parameter is measured at 1:1 frequency,then the frequency is switched to 1:2 and after 20 minutes, it's measured at 1:2 frequency again.
Method of measurement
It will be calculated by the formula(cardiac output divided by body surface area) and collected required data
Secondary outcomes
empty
Intervention groups
1
Description
This design is a quasi-experimental study of pre-test - posttest that compares all those who were at the 1: 1 frequency before and at the start of the intervention with the 1: 2 frequency step.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan shahid chamran hospital
Full name of responsible person
Amir Mirmohammadsadeghy
Street address
Shahid chamran Hospital, After city bridge, Third Ave, Bozorgmehr Square
City
Isfahan
Province
Isfehan
Postal code
۸۱۵۸۳۸۸۹۹۴
Phone
+98 31 3303 3710
Email
am_sadeghi@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Amir Mirmohammadsadeghy
Street address
Isfahan University of Medical Sciences and Health Services, Hezar Jerib Ave, Azadi Square.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Email
am_sadeghi@med.mui.ac.ir
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 mirmohammadsadeghy
Position
Assistant Professor of Medical School
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Beginning of the Tower Garden 1, Corner of the Tower, Nizwan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
1611812345
Phone
+98 31 3773 3390
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 mirmohammadsadeghy
Position
Assistant Professor of Medical School
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Beginning of the Tower Garden 1, Corner of the Tower, Nizwan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
1611812345
Phone
+98 31 3773 3390
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 mirmohammadsadeghy
Position
Assistant Professor of Medical School
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Beginning of the Tower Garden 1, Corner of the Tower, Nizwan, Isfahan
City
Isfahan
Province
Isfehan
Postal code
1611812345
Phone
+98 31 3773 3390
Email
am_sadeghi@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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