Comparative evaluation of the effects of continuous positive airway pressure and zero airway pressure during cardiopulmonary bypass on cardiac de-airing after open heart surgery in patients with rheumatic heart valves diseases.
Aime of study:
Evaluation of the effect of continuous positive airway pressure during cardiopulmonary bypass on cardiac de-airing after open heart surgery
Inclusion criteria:
Patients candidate for aorta and/or mitral valve with/without tricuspid valve replacement surgery; Ejection fraction >40%; Patients without heart surgery; absence of history of dysphasia, odinophagia and previous oesophageal surgery.
Exclusion criteria:
Intra aortic balloon while weaning from CPB.
The study population was patients with rheumatismal heart valves disease that were scheduled for heart valve replacement surgery.
Sample volume: 40 patients
Intervention and oucome of study:
This randomized prospective double blind clinical trial conducted on 40 patients. Control group: During cardiopulmonary pump, the ventilator was turned off and adjustable pressure limit (APL) valve was placed in Spont position. CPAP group: After turning the ventilator off, the flow of oxygen flow was maintained at the rate of 0.5L/min and the APL valve was placed in Man position on 20mbar. During CPB weaning, the patients were observed for air bubbles in left atrium by using TEE.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013043013181N1
Registration date:2013-09-11, 1392/06/20
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-09-11, 1392/06/20
Registrant information
Name
Mojtaba Mansouri
Name of organization / entity
Isfahan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1775 0252
Email address
mansouri@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of medical science
Expected recruitment start date
2012-03-19, 1390/12/29
Expected recruitment end date
2013-03-20, 1391/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative evaluation of the effects of continuous positive airway pressure and zero airway pressure during cardiopulmonary bypass on cardiac de-airing after open heart surgery in patients with rheumatic heart valves diseases.
Public title
Effect of continues positive airway pressure on de-airing process.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients candidate for aorta and/or mitral valve with/without tricuspid valve replacement surgery; Ejection fraction >40%; Patients without heart surgery; absence of history of dysphasia, odinophagia and previous oesophageal surgery.
Exclusion criteria: Intra aortic balloon while weaning from CPB.
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan univesity of medical science
Street address
Isfahan, Hezar Jarib St.
City
Isfahan
Postal code
Approval date
2012-02-01, 1390/11/12
Ethics committee reference number
390539
Health conditions studied
1
Description of health condition studied
cardiac chamber de-airing
ICD-10 code
I05, I06,
ICD-10 code description
Chronic rheumatic heart diseases
Primary outcomes
1
Description
Time of de-airing
Timepoint
from mechanical ventilation bigining untill end of de-airing process
Method of measurement
minute
2
Description
amount of air bubble in left atrium cavity durig de-airing
Timepoint
from mechanical ventilation bigining untill end of de-airing process
Method of measurement
scale: mild, moderate, sever
Secondary outcomes
empty
Intervention groups
1
Description
After turning the ventilator off, the flow of oxygen flow was maintained at the rate of 0.5L/min and the APL valve was placed in “Man” position on 20 mbar (20 hectopascal, 15mmHg).
Category
Prevention
2
Description
During the surgery and CPB, the ventilator (Drager, Fabius) was turned off and the flow of fresh air was totally ceased and adjustable pressure limit (APL) valve was placed in “Spont” position.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Chamran heart hospital
Full name of responsible person
Mojtaba Mansouri
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan university of medical science
Full name of responsible person
Taleb Azarm
Street address
isfahan medical school
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan university of medical science
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
Isfahan Medical School
Full name of responsible person
Mijtaba Mansouri
Position
Associate Professor
Other areas of specialty/work
Street address
Chamran Heart Hospital, Salman-e-farsi St
City
Isfahan
Postal code
Phone
+98 31 1775 0252
Fax
Email
mansouri@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan Medical School
Full name of responsible person
Mojtaba Mansouri
Position
Associate Professor
Other areas of specialty/work
Street address
Chamran Heart Hospital, Salman-e-Farsi St.
City
Isfahan
Postal code
Phone
+98 31 1260 0961
Fax
Email
mansouri@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Mojtaba Mansouri
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
mansouri@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)