Comparison between internal jugular central venous cannulation under ultrasound guidance and anatomical landmark method in pediatric3 months up to 6 years- randomized clinical trial
The aim of the present study was to compare the central venous cannulation of internal jugular vein using ultrasound guidance versus the anatomical landmark techniques in children aged 3 months to 6 years undergoing cardiac surgery referred to Shahid Rajaei Heart Center in Tehran.
Design
The present study is two arm, parallel, open label phase 4 randomized clinical trial that will be performed on patients undergoing cardiac surgery referred to Shahid Rajaei Heart Center in Tehran. Patients are divided into two groups: central venous catheter under ultrasound guidance (A) and anatomical landmark group (B). 120 patients are enrolled in the study. Random sequences will be generated using sealed envelope software.
Settings and conduct
In the anatomical Landmark method by the Seldinger method from the vertex of the triangle formed by the two ends of the sternocleidomastoid muscle and the clavicle bone using a 2 cc syringe (finder) with aspiration in the direction of the nipple on the same side and find the internal jugular vein and then We enter the same place and path with the main syringe and catheter. In the ultrasound guidance method, ultrasound will be performed before cannulation.
Participants/Inclusion and exclusion criteria
Children aged 3 months to 6 years
Inclusion
No thrombosis, No coagulation disorder, Central venous catheters, Absence of central other vein catheter, Infection, Acute infection,
vascular changes
exclusion
Cardiopulmonary arrest
Intervention groups
Intervention Using an ultrasound device to view the carotid artery and adjacent jugular vein and insert a central venous catheter
Control Central venous catheter placement based on anatomical position
Main outcome variables
Success in the first attempt at cannulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210905052379N1
Registration date:2022-01-22, 1400/11/02
Registration timing:registered_while_recruiting
Last update:2022-01-22, 1400/11/02
Update count:0
Registration date
2022-01-22, 1400/11/02
Registrant information
Name
Ali Sadeghi
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center, Iran University of Medical Sciences, Tehran, Iran
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2158
Email address
dr_alisadeghi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-05-20, 1401/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between internal jugular central venous cannulation under ultrasound guidance and anatomical landmark method in pediatric3 months up to 6 years- randomized clinical trial
Public title
Central venous cannulation under ultrasound guidance
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
No thrombosis
No coagulation disorder
Central venous catheters implanted or tunneled
Absence of central femoral and subclavian vein catheter
Infection in the puncture site
Acute infection
Known anatomical and/or functional vascular changes
Exclusion criteria:
Cardiopulmonary arrest
Age
From 3 months old to 6 years old
Gender
Both
Phase
4
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization will be done using seal enveloped software. The list of blocks will be written and numbers will be assigned to them (AABB (1) - ABAB (2) -ABBA (3) -BBAA (4) - BABA (5) - BAAB (6)), then random numbers between one and six ( For example, 1 4 5, etc.) will be select and finally the treatment allocation list based on previous random numbers (AABB, BBAA, BABA, etc.) will be specified.
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
research ethics committee of Rajaie cardiovascular and medical and research center
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2021-07-31, 1400/05/09
Ethics committee reference number
IR.RHC.REC.1400.037
Health conditions studied
1
Description of health condition studied
cardiac disease
ICD-10 code
I51.9
ICD-10 code description
Heart disease, unspecified
Primary outcomes
1
Description
Success in the first attempt at cannulation
Timepoint
Immediately after catheter placement
Method of measurement
Fill out the questionnaire
Secondary outcomes
1
Description
Cannulation time
Timepoint
After catheter placement
Method of measurement
Fill out the questionnaire
2
Description
Additional venous site puncture
Timepoint
Not applicable
Method of measurement
Fill out the questionnaire
3
Description
Incidence of mechanical complications
Timepoint
After cannulation
Method of measurement
Fill out the questionnaire
Intervention groups
1
Description
After induction of anesthesia and sterilization, and by using an ultrasound device and movement of the probe over the carotid artery and the adjacent jugular vein, the location of the vein is confirmed. The catheter is then inserted.
Category
Diagnosis
2
Description
In the anatomical landmark control group, after induction of anesthesia, a catheter is placed at the apex of the triangle, which consists of two parts of the sternocleidomastoid muscle and the right clavicle, according to the anatomical position of the central vein.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Shaheed Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Ali sadeghi
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
dr_alisadeghi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Samideh Khoei
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
research-MC@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Roxana Rastravan
Position
Anesthesiology Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
roxana.rastravan1349@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Ali Sadeghi
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
dr_alisadeghi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Roxana Rastravan
Position
Anesthesiology Fellowship
Latest degree
Subspecialist
Other areas of specialty/work
Anesthesiology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
roxana.rastravan1349@gmail.com
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