Comparison of ultrasound guided central venous catheterization in brachiocephalic vein and internal jugular vein for ease of access and incidence of complications, a clinical trial
Comparison of ultrasound guided central venous catheterization in brachiocephalic vein and internal jugular vein for ease of access and incidence of complications
Design
A study is conducted with parallel group, single blinded, randomized clinical trials.
Patients are divided into two groups based on 4 randomized permutations.
Settings and conduct
Written informed consent is obtained from all patients who are referred to department of interventional radiology of Golestan hospital of Ahvaz for central venous catheterization.Then patients are divided into two groups.
Patients are blinded to group.
Physician blinding is not possible.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Volume resuscitation
Central venous pressure monitoring
Emergent venous access
Hemodialysis
Nutritional support
Inotropes
Age 18 to 80 years
Exclusion criteria:
Venous thrombosis
Uncorrected coagulopathy
Skin site infection
Intervention groups
Patients are divided into two groups of internal jugular vein and brachiocephalic vein .
Main outcome variables
mechanical complication of central venous catheter insertion;Infectious complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170416033470N2
Registration date:2018-08-18, 1397/05/27
Registration timing:prospective
Last update:2018-08-18, 1397/05/27
Update count:0
Registration date
2018-08-18, 1397/05/27
Registrant information
Name
Aliakbar Sahrareizadeh
Name of organization / entity
Ahvaz jundishapur university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3034
Email address
sahraei.a@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of ultrasound guided central venous catheterization in brachiocephalic vein and internal jugular vein for ease of access and incidence of complications, a clinical trial
Public title
complications of catheterization
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Volume resuscitation
Central venous pressure monitoring
Emergent venous access
Hemodialysis
Nutritional support
Inotropes
age 18 to 80 years
Exclusion criteria:
venous thrombosis
uncorrected coagulopathy
skin site infection
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups based on 4 randomized permutations. Patients are blinded to group.
Physician blinding is not possible.
Blinding (investigator's opinion)
Single blinded
Blinding description
Before procedure written informed consent will obtain,and then patients are randomly assigned to one of two groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ahvaz Jundishapur University of Medical Science
Street address
golestan
City
Ahvaz
Province
Khouzestan
Postal code
00988
Approval date
2018-05-19, 1397/02/29
Ethics committee reference number
IR.AJUMS.REC.1397.141
Health conditions studied
1
Description of health condition studied
Infection due to central venous catheter
ICD-10 code
T80.21
ICD-10 code description
Infection due to central venous catheter
2
Description of health condition studied
Bloodstream infection due to central venous catheter
ICD-10 code
T80.211
ICD-10 code description
Bloodstream infection due to central venous catheter
3
Description of health condition studied
Local infection due to central venous catheter
ICD-10 code
T80.212
ICD-10 code description
Local infection due to central venous catheter
Primary outcomes
1
Description
mechanical complication of central venous catheter insertion
Timepoint
During the catheter insertion
Method of measurement
Time measurement and frequency of attempts to insert a catheter based on location
Secondary outcomes
1
Description
Infectious complications
Timepoint
from the time of catheter insertion to 48 h after catheter removal
Method of measurement
According to CDC guideline, CVC-related infection requires a combination of clinical signs of infection, a positive culture of blood aspirated from the catheter or of a catheter segment, and one or more positive blood cultures with the same pathogen taken from a different location.
Intervention groups
1
Description
Intervention group 1: Internal jugular group The steps are as follows: skin scrubbing with Povidone-iodine then CVC placement carried out bedside using the Seldinger technique .US-guided internal jugular approach with a GE voluson E6 (GE Healthcare, the austria) equipped with wide-band linear probe is done. We used real-time US needle guidance with an in-plane technique, with the operator holding the US probe in one hand and manipulating the needle with the other. The US probes and cables were protected by a sterile sheath, and a sterile gel was used for the US guidance procedure. Then under guide of fluoroscopy catheter is fixed.The CVCs were standard polyurethane catheters.
Category
Treatment - Devices
2
Description
Intervention group 2: Brachiocephalic group The steps are as follows: skin scrubbing with Povidone-iodine then CVC placement carried out bedside using the Seldinger technique .US-guided brachiocephalic approach with a GE voluson E6 (GE Healthcare, the austria) equipped with wide-band linear probe is done. We used real-time US needle guidance with an in-plane technique, with the operator holding the US probe in one hand and manipulating the needle with the other. The US probes and cables were protected by a sterile sheath, and a sterile gel was used for the US guidance procedure. Then under guide of fluoroscopy catheter is fixed.The CVCs were standard polyurethane catheters.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Golestan hospital
Full name of responsible person
Asadollah Jalil
Street address
Radiology dep.,Golestan hospital, Golestan Ave.
City
Ahvaz
Province
Khouzestan
Postal code
00988
Phone
+98 61 3374 3001
Fax
Email
sahraei.a@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
00988
Phone
+98 61 3336 2414
Fax
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Azim Motamedfar
Position
Assisstant professor
Latest degree
Subspecialist
Other areas of specialty/work
Interventional radiologist
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
00988
Phone
+98 61 3336 1984
Email
Azexious@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asadollah Jalil
Position
Radilogy resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
00988
Phone
+98 61 3336 1984
Email
asadjalilsh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Asadollah Jalil
Position
Radilogy resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
00988
Phone
+98 61 3336 1984
Email
asadjalilsh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD