Protocol summary

Study aim
Determining the effect of mechanical ventilation with low volume and number during cardiopulmonary pump in heart surgery with the occurrence of pulmonary, renal and liver complications after surgery.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized, 60 participants
Settings and conduct
This study was conducted in Baqiyatullah Hospital with the aim of determining the effect of mechanical ventilation with low volume and number during cardiopulmonary pump in heart surgery with the occurrence of pulmonary, renal and liver complications after surgery.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1. Not a candidate for emergency surgeries 2. No history of open heart surgery 3. Not suffering from known liver, kidney and lung disease. Exclusion criteria: 1. Bleeding after surgery 2. The need for re-surgery for any reason
Intervention groups
After obtaining informed consent from ASA class 1 and 2 CABG candidates, 60 patients were randomly divided into two intervention and control groups of 30. After establishing standard monitoring and IBP and CVP, induction of anesthesia will be done with the same method in patients of both groups. After placing the patient under CPB, patients in the intervention group receive ventilation with a tidal volume (3-4 ml/kg) and a number of 6-8 breaths/minute. Control group doesn't receive any ventilation according to the hospital routine after undergoing CPB. Renal and hepatic parameters are recorded before surgery and on the first, second and third days after surgery. vital signs, duration of mechanical ventilation in ICU-OH, duration of hospitalization in ICU are recorded.
Main outcome variables
Evaluation of pulmonary, renal and hepatic complications after surgery, Evaluation of length of stay in the ICU, Evaluation of hospital costs, Evaluation of patients' satisfaction and quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220102053598N1
Registration date: 2023-02-15, 1401/11/26
Registration timing: prospective

Last update: 2023-02-15, 1401/11/26
Update count: 0
Registration date
2023-02-15, 1401/11/26
Registrant information
Name
Seyed Alireza Amouzegar Zavareh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8806 5203
Email address
s_a_amouzegar69@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-04, 1402/01/15
Expected recruitment end date
2023-07-06, 1402/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An assessment effect of low tidal volume ventilation in on-pump Coronary artery bypass graft surgery on post-operative pulmonary complications.
Public title
An assessment effect of low tidal volume ventilation in on-pump Coronary artery bypass graft surgery on post-operative pulmonary complications.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Not a candidate for emergency surgeries No history of known hepatic, renal and pulmonary disease No history of open heart surgery
Exclusion criteria:
Emergency cardiac surgery Positive history of hepatic, renal and pulmonary disease redo cardiac surgery
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
After obtaining informed consent from ASA class 1 and 2 CABG candidates, 60 patients were randomly divided into two intervention and control groups of 30. Participants were not aware of their group.
Blinding (investigator's opinion)
Double blinded
Blinding description
After obtaining informed consent from ASA class 1 and 2 CABG candidates, 60 patients were randomly divided into two intervention and control groups of 30. After establishing standard monitoring and IBP and CVP, induction of anesthesia will be done with the same method in patients of both groups. After placing the patient under CPB, patients in the intervention group receive ventilation with a tidal volume (3-4 ml/kg) and a number of 6 to 8 breaths per minute. Patients in the control group do not receive any ventilation according to the hospital routine after undergoing CPB. Kidney (BUN, Cr) and liver (SGOT, SGPT, ALKP) parameters are recorded before surgery and on the first, second and third days after surgery. In addition to laboratory parameters, vital signs, duration of mechanical ventilation in ICU-OH, duration of hospitalization in ICU are recorded by a person who does not know the exposure status of patients. The outcome registrar was not aware of the patient group. After collecting and recording data, they are analyzed using SPSS statistical software.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Baqiyatallah Hospital
Street address
no 31, Orfi shirazi Ave, North Sheikh Bahae st, Mollasadra st, Tehran
City
Tehran
Province
Tehran
Postal code
1993653991
Approval date
2022-06-18, 1401/03/28
Ethics committee reference number
Ir.BMSU.BAQ.REC.1401.046

Health conditions studied

1

Description of health condition studied
Atherosclerosis of coronary artery bypass graft(s) without angina pectoris
ICD-10 code
I25. 810
ICD-10 code description
آترواسکلروز پیوند(های) بای پس عروق کرونر بدون آنژین صدری

Primary outcomes

1

Description
Hepatic Enzymes
Timepoint
Before surgery, the fist, second and third days after surgery
Method of measurement
Serology laboratory

2

Description
Renal function parameters
Timepoint
Before surgery, the fist, second and third days after surgery
Method of measurement
Serology laboratory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: After the patient is placed under CPB, they receive ventilation with a flow volume (3-4 ml/kg) and a number of 6 to 8 breaths per minute.Control group: after placing the patient under CPB, no ventilation will be done according to the usual method, and the patient's lungs will collapse during the pump and will not be ventilated.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Baqiatallah Hospital
Full name of responsible person
Seyed Mohammad Reza Amouzegar Zavareh
Street address
Baqiatallah Hospital, st. Molasadra
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
amouzegar12@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Mohsen Saberi
Street address
Baqiatallah Hospital, Mollasadra St.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
msaberi@bmsu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Baqiatallah Hospital
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
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Amouzegar Zavareh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Baqiatallah Hospital, Mollasadra St.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
amouzegar12@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Amouzegar Zavareh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Baqiatallah Hospital, Mollasadra St.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
amouzegar12@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Bagheiat-allah University of Medical Sciences
Full name of responsible person
Seyed Mohammad Reza Amouzegar Zavareh
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Education
Street address
Baqiatallah Hospital, Mollasadra St.
City
Tehran
Province
Tehran
Postal code
1435915371
Phone
+98 21 81261
Email
amouzegar12@yahoo.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
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
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