Comparison of continuation or cessation of ventilation during cardiopulmonary bypass on postoperative respiratory function in smokers undergoing cardiac surgery
Comparison of establishing or stopping ventilation during cardiopulmonary bypass on postoperative respiratory parameters in smokers undergoing cardiac surgery
Design
Clinical trial with two parallel groups, double blind, randomized by flip the coin method, sample size of 40 patients
Settings and conduct
Study place: Cardiac operating room and cardiac intensive care unit of Shahid Modarres Hospital in Tehran; Study population: Smoking patients undergoing heart surgery with cardiopulmonary bypass; Type of blinding: double blind; How to blind: Postoperative caregivers and evaluators of outcomes are not aware of the study group
Participants/Inclusion and exclusion criteria
Inclusion criteria: smokers (smoking more than 100 cigarettes and consuming at least one cigarette in the last 28 days); Age over 40 years; Cardiac surgery with cardiopulmonary bypass.
Exclusion criteria: emergency surgery; Dissatisfaction with participation.
Intervention groups
Intervention group: continuation of ventilation with low tidal volume and low respiratory rate during cardiopulmonary bypass. Control group: stopping ventilation during cardiopulmonary bypass in conventional method
Main outcome variables
Arterial blood oxygen pressure (Pao2); Arterial blood carbon dioxide pressure ( Paco2) and the ratio of arterial blood oxygen pressure to the percentage of oxygen inhaled (Pao2/Fio2) by the blood gas analyzer
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180724040575N5
Registration date:2021-09-29, 1400/07/07
Registration timing:prospective
Last update:2021-09-29, 1400/07/07
Update count:0
Registration date
2021-09-29, 1400/07/07
Registrant information
Name
kamal fani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2207 4095
Email address
kamalfani@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2022-02-20, 1400/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of continuation or cessation of ventilation during cardiopulmonary bypass on postoperative respiratory function in smokers undergoing cardiac surgery
Public title
The effect of ventilation during cardiopulmonary bypass on postoperative respiratory condition
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Adult patients referred to the operating room for heart surgery
Being at the age of over 40 years old
Smokers who smoke more than 100 cigarettes and have smoked at least 1 cigarette in the last 28 days
Exclusion criteria:
Refusal to give informed consent
Emergency operation
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization by flip the coin method. The allocation of two sides of a coin to each of the study groups is determined and then the number of coin samples is thrown and recorded.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and the recorder of the research questionnaire are kept blind on stopping or continuing ventilation during cardiopulmonary pump. All patients confirm the consent but are not informed of their placement in which group. The anesthesiologist will prescribe the ventilation method based on the pre-determined group, but the person registering the questionnaire who is in the intensive care unit is not aware of the groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Anesthesia Research Center; Taleghani Hospital; Velenjak
City
Tehran
Province
Tehran
Postal code
19969111151
Approval date
2020-11-22, 1399/09/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1399.714
Health conditions studied
1
Description of health condition studied
Cardiac surgery in smoker patient
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Arterial blood oxygen pressure (Pao2)
Timepoint
Before and after surgery and at 1, 6 and 24 hours after transfer to the intensive care unit
Method of measurement
Blood Gas Analyzer
Secondary outcomes
1
Description
Arterial blood carbon dioxide pressure
Timepoint
Before and after surgery and at 1, 6 and 24 hours after transfer to the intensive care unit
Method of measurement
Blood Gas Analyzer
2
Description
The ratio of arterial blood oxygen pressure to the oxygen content of inhaled gas (Pao2/Fio2)
Timepoint
Before and after surgery and at 1, 6 and 24 hours after transfer to the intensive care unit
Method of measurement
Blood Gas Analyzer
Intervention groups
1
Description
Intervention group:In patients who smoke undergoing heart surgery, the ventilation of the lungs with 5 breaths /min. and a respiratory tidal volume of 3 ml /kg of body weight with an end expiratory pressure of 5 mm Hg continues during the establishment of cardiopulmonary bypass.
Category
Prevention
2
Description
Control group: In patients who smoke undergoing heart surgery, the ventilation of the lungs is stopped during the establishment of cardiopulmonary bypass.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Modarres Hospital
Full name of responsible person
Kamal Fani
Street address
Modarres Hospital, Saadat Abad Ave.
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4099
Email
kamalfani@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarqhi
Street address
Anesthesiology Research Center, Taleqhani Hospital, Velenjak
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4099
Email
kamalfani@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital, Saadat Abad Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4099
Email
kamalfani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital, Saadat Abad Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4099
Email
kamalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kamal Fani
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Modarres Hospital, Saadat Abad Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4099
Email
kamalfani@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