The aim of this study was to investigate the complications of
Midpoint versus lateral approaches for subclavian vein catheterization
during coronary artery bypass graft (CABG) surgery
Design
Two arm parallel group randomised clinical trial with blinded postoperative care and outcome assessment.
Settings and conduct
This study is a randomized clinical trial that is performed in Farshchian Heart hospital in hamadan.The patients were randomly assigned to one of the two groups (Midpoint or lateral approach for subclavian vein catheterization) of the trial using block randomization method (size of block = 4). The blindness of physician was not possible, Therefore, It is a Single blinded study.
Participants/Inclusion and exclusion criteria
ّInclusion criteria: Four hundred and forty patients of aged between 25 and
89 years who schedule to undergo coronary artery bypass graft surgeries are enrolled for the study.
Exclusion criteria: Previously thoracic surgery; Infection in catheterizetion site and emergency surgery
Intervention groups
After induction of anesthesia and tracheal intubation, The cannulations will done through Midpoint(Inserting the needle 2 to 3 cm inferior to the midpoint of the clavicle) or Lateral Approach(Inserting the needle1 to 2 cm lateral to the midclavicular line) for subclavian vein catheterization.
Main outcome variables
Success of catheterization and
Complications of subclavian vein catheterization:
Malposition, subclavian artery puncture, Pneomotorax, Hematoma at puncture
site.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120721010348N5
Registration date:2018-05-29, 1397/03/08
Registration timing:registered_while_recruiting
Last update:2018-05-29, 1397/03/08
Update count:0
Registration date
2018-05-29, 1397/03/08
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
Expected recruitment start date
2018-04-29, 1397/02/09
Expected recruitment end date
2018-10-31, 1397/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Influence of cannulation point during infraclavicular subclavicular vein catheterization in coronary artery bypass graft surgery
Public title
complications of subclavicular vein catheterization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients of aged between 25 and 89 years who schedule to undergo coronary artery bypass graft surgeries are enrolled for the study.
Exclusion criteria:
Previously thoracic surgery;
Infection in catheterizetion site
Emergency surgery
Age
From 25 years old to 89 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Outcome assessor
Data analyser
Sample size
Target sample size:
440
Randomization (investigator's opinion)
Randomized
Randomization description
The patients were randomly assigned to one of the two groups ( Lateral or Midpoint Approach for catheterization) of the trial using randomly blocks(size of block = 4)
Blinding (investigator's opinion)
Single blinded
Blinding description
All patients are randomized selected as L (lateral apprqach) or M (Midpoint approach) papers for catheterization. Outcome assessor and Data analyser only encounter with L or M papers.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Fahmedah street, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
08138381747
Approval date
2018-04-28, 1397/02/08
Ethics committee reference number
IR.UMSHA.REC.1397.35
Health conditions studied
1
Description of health condition studied
External causes of morbidity and mortality
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
Control group: The catheter will be inserted in right subclavein vein through Midpoint approach.
Category
Prevention
2
Description
Intervention group: The catheter will be inserted in right subclavein vein through Lateral approach.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Masoud Tarbiat
Street address
Hamadan University of Medical Sciences، Fahmideh Street، Hamedan, IRAN
City
Hamadan
Province
Hamadan
Postal code
38381742
Phone
+98 81 3820 1506
Fax
+98 81 3838 1742
Email
masoudtarbiat@gmail.com
Web page address
http://www.umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Saeid Bashirian
Street address
Vice Cbanceller for Research and Technology of Hamadan University of Medical Sciences, Hamadan University of Medical Sciences، Fahmideh Street، Hamadan, IRAN
City
Hamadan
Province
Hamadan
Postal code
3831742
Phone
+98 81 3820 1506
Fax
+98 81 3838 1745
Email
mt_383@yahoo.com
Web page address
http://www.umsha.ac.ir
Grant name
Vice Cbanceller for Research and Technology of Hamedan University of Medical Sciences
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
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Masoud Tarbiat
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Nomber 293، West Block 22، Kashani Street، Hamadan
City
Hamadan
Province
Hamadan
Postal code
64517669644
Phone
+98 81 3820 1506
Fax
+98 81 1826 8034
Email
masoud.tarbiat@umsha.ac.ir
Web page address
http://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
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Nomber 293، West Block 22، Kashani Street، Hamadan
City
hamadan
Province
Hamadan
Postal code
6517669644
Phone
+98 81 3820 1506
Fax
+98 81 1826 8034
Email
masoud.tarbiat@umsha.ac.ir
Web page address
htpp://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
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Nomber 293، West Block 22، Kashani Street، Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517669644
Phone
+98 81 3820 1506
Fax
+98 81 1826 8034
Email
masoud.tarbiat@umsha.ac.ir
Web page address
http://www.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available