Protocol summary

Summary
In this study , we compare left and right subclavein vein Catheter placement complications in patients who undergoing coronary artery bypass graft surgery.The patients will be studied in two groups randomly. Inclusion criteria are all patients between 19 to 100 years old that candidate for coronary artery bypass graft surgery with LIMA graft.Exclusion criteria are patients who undergone thoracic surgery previously. Numbers of patients in this study are 148. Complications of catheter placement detect with surgeon and chest x-ray and manage by surgeon and anesthesiologist.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012072110348N1
Registration date: 2012-10-29, 1391/08/08
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-10-29, 1391/08/08
Registrant information
Name
Masoud Tarbiat
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1825 1244
Email address
masoud.tarbiat@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Maevante Pajoheshi، Hamedan University of Medical Sciences
Expected recruitment start date
2012-09-22, 1391/07/01
Expected recruitment end date
2012-12-05, 1391/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of left and right subclavian vein catheter placement complications in patients who undergoing coronary artery graft. Surgery
Public title
Complications of left and right subclavian vein catheter placement.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria :All patients who undergo coronary artery graft with LIMA graft and all patients between 19 to 100 years old. Exclusion criteria:The patients who undergone thoracic surgery previously.
Age
From 19 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 148
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
Hamedan University of Medical Sciences
Street address
Hamedan University of Medical Sciences ، Shariaty cross، Hamedan
City
Hamedan
Postal code
83512544
Approval date
2012-06-16, 1391/03/27
Ethics committee reference number
1021/9/35/16/پ/د

Health conditions studied

1

Description of health condition studied
Catherization
ICD-10 code
y70
ICD-10 code description
Medical devices associated with adverse incidents in diagnostic and therapeutic use

Primary outcomes

1

Description
Catheter location(position)
Timepoint
One day after Catheterization
Method of measurement
Chest x-ray

Secondary outcomes

1

Description
LIMA injery
Timepoint
After openning chest wall
Method of measurement
Observation by sergeon

Intervention groups

1

Description
The patients of coronary artery bypass graft surgery divided in two groups randomly.In one group,the catheter will be inserted in left subclavein vein.
Category
Prevention

2

Description
In other group, the catheter will be inserted in right subclavein vein.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ekbatan Hospital
Full name of responsible person
Masoud Tarbiat
Street address
Ekbatan Hospital، Talaghani street، Hamedan
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan university of Medical Sciences
Full name of responsible person
Masoud Tarbiat
Street address
Hamedan University of Medical Sciences ، Shariaty cross، Hamedan
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Maryam Davoudi
Position
Anesthesiologist
Other areas of specialty/work
Street address
Ekbatan Hospital، Hamedan
City
Hamedan
Postal code
6516836599
Phone
+98 81 1828 0097
Fax
Email
mdavoudi10@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedam University Of Medical Sciences
Full name of responsible person
Masoud Tarbiat
Position
Anesthesiologist، Fellowship of cardiac Anesthesia
Other areas of specialty/work
Street address
Hamedam University Of Medical Sciences
City
Hamedam
Postal code
826804411
Phone
+98 81 1423 2052
Fax
+98 81 1825 1255
Email
Masoud.tarbiat@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
Masoud Tarbiat
Position
Anesthesiologist، Fellowship of cardiac Anesthesia
Other areas of specialty/work
Street address
Ekbatan Hospital، Hamedan
City
Hamedan
Postal code
826804411
Phone
+98 81 1423 2052
Fax
Email
mt_383@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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