In this study, we compare complications between supraclavicular and subclavicular methods in subclavian vein catheterization in patients who undergoing cardiac surgery. The patients will be studied in two groups randomly. Numbers of patients in this study are 280. Inclusion criteria: All patients between 25 to 100 years old that candidate for cardiac surgery. Exclusion criteria: Previously thoracic surgery and infection in catheterizetion site. 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:IRCT2014102210348N3
Registration date:2014-11-30, 1393/09/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-11-30, 1393/09/09
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
Hamedan University of Medical Sciences
Expected recruitment start date
2014-10-23, 1393/08/01
Expected recruitment end date
2015-04-21, 1394/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of associated complications between supraclavicular and subclavicular methods in subclavian vein catheterization
Public title
Complications of subclavian vein catheterization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients between 25 to 100 years old that candidate for cardiac surgery.
Exclusion criteria: Previously thoracic surgery; Infection in catheterizetion site
Age
From 25 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
280
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
2014-10-19, 1393/07/27
Ethics committee reference number
3521/9/35/16/پ
Health conditions studied
1
Description of health condition studied
Medical devices associated with adverse incidents in diagnostic and therapeutic use
ICD-10 code
Y70، Y82
ICD-10 code description
Medical devices associated with adverse incidents in diagnostic and therapeutic use
Primary outcomes
1
Description
Catheter malposition
Timepoint
One day after surgery
Method of measurement
Chest X- ray
Secondary outcomes
1
Description
Injury to subclavian artery
Timepoint
During catheterization
Method of measurement
Observation by physician
Intervention groups
1
Description
The catheter will be inserted in right subclavein vein by supraclavicular method.
Category
Prevention
2
Description
The catheter will be inserted in right subclavein vein by infraclavicular method.
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، Taleghani Street، Hamedan
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Hamedan University of Medical Sciences، Fahmideh Street، Hamedan
City
Hamedan
Grant name
معاونت تحقيقات و فناوري دانشگاه علوم پزشكي همدان
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
Masoud Tarbiat
Position
Fellowship of Cardiac Anesthesia، Anesthesiogist
Other areas of specialty/work
Street address
Nomber 293، West Block 22، Kashani Street، Hamedan
City
Hamedan
Postal code
4144775889
Phone
+98 81 3423 2052
Fax
Email
masoudtarbiat@gmail.com
Web page address
www.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University Of Medical sciences
Full name of responsible person
Masoud Tarbiat
Position
Fellowship of Cardiac Anesthesia، Anesthesiologist
Other areas of specialty/work
Street address
Nomber 293، West Block 22، Kashani Street، Hamedan
City
Hamedan
Postal code
4144775889
Phone
+98 81 3423 2052
Fax
Email
masoudtarbiat@gmail.com
Web page address
www.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University Of Medical sciences
Full name of responsible person
Masoud Tarbiat
Position
Fellowship of Cardiac Anesthesia، Anesthesiologist
Other areas of specialty/work
Street address
Nomber 293، West Block 22، Kashani Street، Hamedan
City
Hamedan
Postal code
4144775889
Phone
+98 81 3423 2052
Fax
Email
masoudtarbiat@gmail.co
Web page address
www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)