Protocol summary

Study aim
ِDetermination the Effect of Positive End-Expiratory Pressure (PEEP) of 15 CmH2O on the Amount of Bleeding After Emergency Coronary Artery Bypass Surgery (CABG) without Using Cardiopulmonary Bypass Pump.
Design
Blocking (blocks of four) Due to the lack of similar study and the pilot of this research, as well as the number of patients in other studies, the sample size was considered to be 50 patients in each group. This study has been proposed as a hypothesis by the researchers, and due to the lack of similar studies, it is only predicted that there is a difference in the reduction of bleeding after the operation. Considering the conditions of these patients and the importance of the issue, any reduction in bleeding is important.
Settings and conduct
All patients referred to the cardiac emergency of Imam Reza & Qaim hospitals with coronary artery occlusion who candidates for emergency coronary artery bypass surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients who have been diagnosed with coronary artery occlusion and referred to the cardiac emergency department of Imam Reza and Qaim Hospital and after performing the initial diagnostic procedures, are candidates for emergency Coronary artery bypass surgery Exclusion criteria: Patient's death, lack of consent to participate in the study
Intervention groups
In the intervention group, after bypass operation and usual treatment, including FFP injection, tranexamic acid, platelet injection and if necessary, return to the operating room, etc., patients in the ICU were treated with PEEP equivalent to 15 cm H2O until ventilators is needed. In the conventional treatment group, patients will be treated with PEEP equivalent to 5 cmH2O and other conventional treatments.
Main outcome variables
The amount of bleeding from pericardial and thoracic drains (in cc) in the first 6, 12, and 24 hours after surgery

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20231021059798N1
Registration date: 2023-11-19, 1402/08/28
Registration timing: retrospective

Last update: 2023-11-19, 1402/08/28
Update count: 0
Registration date
2023-11-19, 1402/08/28
Registrant information
Name
Ahmadreza Sadeghipour kermani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3844 8417
Email address
ahmadreza.sadeghipour22@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
2022-09-23, 1401/07/01
Actual recruitment end date
2023-05-21, 1402/02/31
Trial completion date
2023-05-21, 1402/02/31
Scientific title
Assessment the Effect of Positive End-Expiratory Pressure (PEEP) of 15 CmH2O on the Amount of Bleeding After Emergency Coronary Artery Bypass Surgery (CABG) without Using Cardiopulmonary Bypass Pump.
Public title
Assessment the Effect of Positive End-Expiratory Pressure (PEEP) of 15 CmH2O on the Amount of Bleeding After Emergency Coronary Artery Bypass Surgery (CABG) without Using Cardiopulmonary Bypass Pump
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients who referred to the cardiac emergency department of Imam Reza Hospital with coronary artery occlusion and after performing the initial diagnostic procedures, are candidates for emergency Coronary artery bypass surgery (CABG). All patients who referred to the cardiac emergency department of Qaim Hospital with coronary artery occlusion and after performing the initial diagnostic procedures, are candidates for emergency Coronary artery bypass surgery (CABG).
Exclusion criteria:
Patient's death lack of consent to participate in the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blocking (blocks of four)- In order to ensure an equal number of patients in the intervention and control groups, 2 patients are assigned to the intervention and 2 patients to the control in each block. Allocation of patients to intervention group and control group in each block is completely random. For example, the sequence of AABB- ABBA- BABA and... can be created in each block according to randomization.
Blinding (investigator's opinion)
Double blinded
Blinding description
Due to obtaining informed consent from the patients before entering the study, the patients do not know how to be assigned to the intervention or control group. Also, the data analyst does not know the group assigned to the patients.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
No. 19, Farvardin 19, Naser Khosro Ave., Ahmad Abad Bivd., Mashhad City
City
Mashad
Province
Razavi Khorasan
Postal code
9176856587
Approval date
2022-04-26, 1401/02/06
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.708

Health conditions studied

1

Description of health condition studied
Coronary artery occlusion
ICD-10 code
I21.9
ICD-10 code description
Acute myocardial infarction, unspecified

Primary outcomes

1

Description
The amount of bleeding after CABG
Timepoint
In the first 6, 12, and 24 hours after surgery
Method of measurement
The amount of bleeding from pericardial and thoracic drains (in cc)

2

Description
Blood hemoglobin level
Timepoint
In the first 6, 12, 24 and 48 hours after surgery
Method of measurement
Cell Counter

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: after bypass operation and usual treatment, including FFP injection, tranexamic acid, platelet injection and if necessary, return to the operating room, etc., patients in the ICU were treated with PEEP equivalent to 15 cm H2O until ventilators is needed.
Category
Treatment - Other

2

Description
Control group: after bypass operation and usual treatment, including FFP injection, tranexamic acid, platelet injection and if necessary, return to the operating room, etc., patients in the ICU were treated with PEEP equivalent to 5 cm H2O until ventilators is needed.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza and Qaim Hospitals
Full name of responsible person
Ahmad Reza Sadeghipour Kermani
Street address
No. 19, Farvardin Ave., Naser khosro, Ahmad Abad Blvd., Qods Town
City
Mashhad
Province
Razavi Khorasan
Postal code
9176856587
Phone
+98 915 313 8507
Email
ahmadreza.sadeghipour22@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Daneshgah Ave., Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
345 - 91375
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Reza Sadeghipour Kermani
Position
Resident Of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 19, Farvardin 19, Naser Khosro Ave., Ahmad Abad Bivd., Mashhad City
City
Mashhad
Province
Razavi Khorasan
Postal code
9176856587
Phone
+98 51 3844 8417
Email
ahmadreza.sadeghipour22@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Reza Sadeghipour Kermani
Position
Resident of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 19, Farvardin 19, Naser Khosro Ave., Ahmad Abad Bivd., Mashhad City
City
Mashhad
Province
Razavi Khorasan
Postal code
9176856587
Phone
+98 51 3844 8417
Email
ahmadreza.sadeghipour22@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Reza Sadeghipour Kermani
Position
Resident Of Surgery
Latest degree
Medical doctor
Other areas of specialty/work
General Surgery
Street address
No. 19, Farvardin 19, Naser Khosro Ave., Ahmad Abad Bivd., Mashhad City
City
Mashhad
Province
Razavi Khorasan
Postal code
9176856587
Phone
0098518448417
Email
ahmadreza.sadeghipour22@gmail.com

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
Not applicable
Data Dictionary
Not applicable
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