Objective and Background:
Postoperative pulmonary dysfunction is one of the most frequent complications after cardiac surgery that believed to result from the use of Cardiopulmonary bypass (CPB). In this study We investigated the effect of low tidal volume ventilation during Cardiopulmonary bypass on postoperative gas exchange and lung mechanics.
Methods:
This prospective randomized study included 100 patients undergoing elective coronary artery bypass graft. In 50 patients low tidal volume ventilation (T.V= 3 cc/kg , RR= 12/min , FIO2= 100% , PEEP= 5 cmH2o) was applied during CPB (group I). In the other 50 patients (group II) the lungs were open to the atmosphere without ventilation. Measurements were taken preoperatively, after CPB and before discharge.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138902283954N1
Registration date:2010-06-22, 1389/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2010-06-22, 1389/04/01
Registrant information
Name
Mohammad Hossein Bakhshaei
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1826 9403
Email address
bakhshaei@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Researcher
Expected recruitment start date
2008-01-20, 1386/10/30
Expected recruitment end date
2009-03-20, 1387/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Low Tidal Volume Ventilation during Cardiopulmonary Bypass on Pulmonary Function after Cardiac Surgery
Public title
Ventilation during Cardiopulmonary Bypass
Purpose
Supportive
Inclusion/Exclusion criteria
Exclusion criteria were: ASA (American Society of Anesthesia) class> III, age> 70 years, poor left ventricular function (LVEF <40%), valvular heart disease,
re operation, renal impairment and significant pulmonary disease as defined by preoperative FEV1 and FVC values less than 40% of predicted
Age
From 40 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
empty
Ethics committee reference number
پ/16/70/2/37597
Health conditions studied
1
Description of health condition studied
Genearl Anesthesia in Coronary Disease
ICD-10 code
I25.0
ICD-10 code description
Atherosclerotic cardiovascular disease, so described
Primary outcomes
1
Description
PaO2
Timepoint
after induction of anesthesia and endotracheal intubation and before sternotomy, 5 minutes , 2 and 4 hours after completion of CPB and after extubation in ICU
Method of measurement
mm/Hg
2
Description
FEV1
Timepoint
Time of extubation, preoperative and in the 5th postoperative day
Method of measurement
Liter
3
Description
FVC
Timepoint
Time of extubation, preoperative and in the 5th postoperative day
Method of measurement
Liter
Secondary outcomes
empty
Intervention groups
1
Description
Group I underwent low tidal volume ventilation (T.V= 3 cc/kg , RR= 12 / min , FIo2= 100% , PEEP= 5 cmH2o) during CPB period
Category
Treatment - Other
2
Description
Control group did not receive any ventilation during bypass
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Dr M.H. Bakhshaei
Street address
Ekbatan Hospital,
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research deputy of Hamedan University of Medical Sciences
Full name of responsible person
Dr M.H Bakhshaei
Street address
Hamedan University of Medical Sciences
City
Hamedan
Grant name
پایان نامه های دانشجوئی
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research deputy of Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr M.H Bakhshaei
Position
Assistat Professor, Fellowship of cardiac Anesthesia
Other areas of specialty/work
Street address
Ekbatan hospital
City
Hamedan
Postal code
65167-7-9593
Phone
+98 81 1826 9403
Fax
+98 81 1826 9835
Email
bakhshaei@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan Univrsity of Medical Sciences
Full name of responsible person
Dr M.H Bakhshaei
Position
Assistant Professor, Fellowship of cardiac Anesthesia
Other areas of specialty/work
Street address
Ekbatan Hospital
City
Hamedan
Postal code
65167-7-9593
Phone
+98 81 1826 9403
Fax
+98 81 1826 9835
Email
bakhshaei@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr M.H Bakhshaei
Position
Assistant Professor, Fellowship of Cardiac Anesthesia
Other areas of specialty/work
Street address
Ekbatan hospital
City
Hamedan
Postal code
65167-7-9593
Phone
+98 81 1826 9403
Fax
+98 81 1826 9835
Email
bakhshaei@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)