The present study is a randomized, single-blind, non-placebo controlled and single-center clinical trial.
The aim of this study is comparison of pleural effusion in Jackson-Pratt drain versus chest-tube after coronary artery bypass graft surgery.
Inclusion criteria: Patients 18-75 year-old who are candidates of coronary artery bypass graft (CABG) surgery based on medical history, physical examination, echocardiographic and angiographic findings.
Exclusion criteria: Patients who are treating by anti-coagulant drugs. Also patients who are not accessible to be followed up and patients with congenital heart disease will be excluded.
First intervention group: After CABG surgery in the operation room, we insert chest tube through left pleural space under the sub-xiphoid region and its size is based on the surgeon idea and patient's condition. Then we put 19-French Jackson drain in mediastinum under the sub-xiphoid region.
Second intervention group: After CABG surgery in the operation room, we insert chest tube through left pleural space under the sub-xiphoid region and its size is based on the surgeon idea and patient's condition. Then we put another chest tube in mediastinum under the sub-xiphoid region.
The sample size in each group according to the formula that compare two ratios calculated 97 individuals for each group.
After admitting the patient in recovery unit or cardiac care unit, total amount of drainage (24 hours after operation) will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201701193362N3
Registration date:2017-04-02, 1396/01/13
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-04-02, 1396/01/13
Registrant information
Name
Mohsen Mir Mohammad Sadeghi
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1260 2512
Email address
mirmohammadsadeghi@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for reseach, Isfahan University of Medical Sciences
Expected recruitment start date
2015-10-22, 1394/07/30
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of comparison of pleural effusion in Jackson-Pratt drain versus mediastinal chest-tube after coronary artery bypass graft surgery
Public title
Comparison of pleural effusion in Jackson-Pratt drain versus chest-tube after coronary artery bypass graft surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
18 to 75 years patients; patients according to there examination, medical history and results of echocardiography and angiography, need coronary artery bypass surgery
Exclusion criteria:
Patients treated with anticoagulant drugs; unable to follow-up; requiring repeated surgery; patients with congenital heart disease
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
194
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done by Random allocation.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjerib street, Isfahan
City
Isfahan
Postal code
Approval date
2015-05-28, 1394/03/07
Ethics committee reference number
IR.MUI.REC.1394.3.795
Health conditions studied
1
Description of health condition studied
Pleural effusion
ICD-10 code
J90
ICD-10 code description
Pleural effusion, not elsewhere classified
Primary outcomes
1
Description
Pleural effusion
Timepoint
A month after operation
Method of measurement
Chest X-ray
Secondary outcomes
1
Description
Amount of drainage
Timepoint
24 hours after operation
Method of measurement
Observation
2
Description
Pain score after the operation
Timepoint
2 hours after hospitalization in public sector, 24 hours after operation, 48 hours after operation, at the time of discharge
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1:
After CABG surgery in the operation room, we insert chest tube through left pleural space under the sub-xiphoid region and its size is based on the surgeon idea and patient's condition. Then we put 19-French Jackson Pratt drain in mediastinum under the sub-xiphoid region.
Category
Treatment - Other
2
Description
Intervention group 2:
After CABG surgery in the operation room, we insert chest tube through left pleural space under the sub-xiphoid region and its size is based on the surgeon idea and patient's condition.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Cardiology Clinic of Chamran hospital in Isfahan
Full name of responsible person
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Dr. Pejman Pourazari Najafabadi
Street address
Alzahra hospital, Sofe treet, Isfahan
City
Isfahan
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Vice chancellor for research, Isfahan University of Medical Sciences