Comparison of volumetric mechanical ventilation with compressive mechanical ventilation after cardiac surgery
Design
Double-blind clinical trial
Settings and conduct
After obtaining written approval from the Ethics Committee of Tabriz University of Medical Sciences and obtaining written informed consent from all patients, the number ... , According to a randomized list in one of two groups.
Participants/Inclusion and exclusion criteria
All patients over 18 years of age who are candidates for elective cardiac surgery with the help of cardiopulmonary pump at Shahid Madani Hospital.
Intervention groups
Volume mechanical ventilation group A group with pressure mechanical ventilation and comparison between them after cardiac surgery.
Comparing volume control versus pressure control mechanical ventilation after cardiac surgery on respiratory parameters
Public title
Effect of mechanical ventilation mode after cardiac surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patient upper 18 year old of elective candid cardiac surgury to cardiacpulmonary pump in the madani hospital
Exclusion criteria:
Less than 18 years old
Emergency surgery
Emergency surgery is not use cardiopulmonary pump
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Adult Patients Candidate for Elective Cardiac Surgery with Cardiopulmonary Pump at Shahid Madani Heart Hospital Refer to the Operating Room, respectively, according to a randomized list in one of two groups ...
Patients are randomly selected in a time series using volumetric mechanical and pressure mechanical ventilation during and after surgery.
Blinding (investigator's opinion)
Double blinded
Blinding description
Adult patients who are candidates for elective cardiac surgery with cardiopulmonary pump at Shahid Madani Heart Hospital are randomly assigned to one of two groups according to the prepared list and participants are blinded to medical treatment.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Research in Tabriz University of Medical Sciences
Street address
Daneshgah street
City
Tabriz
Province
East Azarbaijan
Postal code
5719915674
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.TBZMED.REC.1398.1235
Health conditions studied
1
Description of health condition studied
Comparison of volumetric mechanical ventilation with compression after cardiac surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The effect of age, sex, weight, type of cardiac surgery, duration of cardiopulmonary period, need for mechanical ventilation and duration of ICU hospitalization on compressive and volumetric mechanical ventilation
Timepoint
Up to 12 months
Method of measurement
weight and hour
Secondary outcomes
1
Description
Complications after cardiac surgery with different mechanical ventilation modalities
Timepoint
From 6 hours after surgery until discharge after surgery
Method of measurement
Time control of complications with different mechanical ventilation modes
Intervention groups
1
Description
People receiving voluntary mechanical ventilation after cardiac surgery will be considered as the control group, and those undergoing pressure mechanical ventilation will be considered as the intervention group, early and late complications and duration of hospital discharge will be assessed.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani hospital
Full name of responsible person
Tohid mahooti
Street address
Daneshgah street.madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5719915674
Phone
+98 44 3343 3633
Email
hi.hooti1992@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohamadreza ardalan
Street address
Daneshgah street.madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5719915674
Phone
+98 44 3343 3633
Email
hi.hooti1992@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Organization
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
Tabriz University of Medical Sciences
Full name of responsible person
Tohid mahooti
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Daneshgah street.madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5719915674
Phone
+98 44 3343 3633
Email
hi.hooti1992@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tohid mahooti
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Daneshgah street.madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5719915674
Phone
+98 44 3343 3633
Email
hi.hooti1992@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Tohid mahooti
Position
Medical student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Daneshgah street.madani hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5719915674
Phone
+98 44 3343 3633
Email
hi.hooti1992@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Data can be played back with respect to patients' rights and their satisfaction
When the data will become available and for how long
Access after printing is completed
To whom data/document is available
Anyone can use it.
Under which criteria data/document could be used
No special conditions for now.
From where data/document is obtainable
E-mail and phone calls and websites. hi.hooti1992yahoo.com, 00989146328349
What processes are involved for a request to access data/document
Refer to thesis reference and use thesis text if needed