Comparing the two different methods of the internal jugular central venous catheter in infants under one-month-old
Design
A parallel-group, double-blind, simple randomized, N/A phase clinical trial on 64 patients
Settings and conduct
Patients hospitalized in Mofid Hospital were randomly assigned to needle (22 G) or angiocath (22 G) catheterizations. After general anesthesia, patients are placed in the Trendelenburg 30 position and after sterilizing the skin, catheterization is performed by a pediatric anesthetist or fellowship under ultrasound guidance. The primary site of choice for catheterization is the right internal jugular vein. In case of unsuccessful catheterization, it will be done in the left internal jugular vein. Patients and their families were blinded to group allocation. Also, the data analyzer was blinded to the assigned group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: infants under one month old who are candidates for central venous catheterization
The lack of access to a suitable peripheral vein in critically ill babies who are hospitalized for a long time or need TPN (total parenteral nutrition).
Exclusion criteria:
Central vein anomalies
catheter site thrombosis
catheter site infection
Intervention groups
The group of internal jugular central vein catheterization with needle and angiocath in babies under one month
Main outcome variables
The number of attempts for successful venipuncture
The time required for successful venipuncture
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210505051197N2
Registration date:2023-09-26, 1402/07/04
Registration timing:prospective
Last update:2023-09-26, 1402/07/04
Update count:0
Registration date
2023-09-26, 1402/07/04
Registrant information
Name
Malek Moien Ansar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0884
Email address
ansarmoien@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-07, 1402/07/15
Expected recruitment end date
2023-11-21, 1402/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the two different methods of the internal jugular central venous catheter in infants under one-month-old
Public title
Comparing the two different methods of the internal jugular central venous catheter in infants under one-month-old
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
infants under one month old who are candidates for central venous catheterization
The lack of access to a suitable peripheral vein in critically ill babies who are hospitalized for a long time or need TPN (total parenteral nutrition)
Exclusion criteria:
Central vein anomalies
catheter site thrombosis
catheter site infection
Age
From 1 day old to 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients and their families were blinded to group allocation. Also, the data analyzer was blinded to the assigned group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Vice-Chancellor in Research Affairs - Shahid Beheshti University of Me
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
4167811969
Approval date
2022-07-24, 1401/05/02
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.191
Health conditions studied
1
Description of health condition studied
During aspiration, puncture and other catheterization
ICD-10 code
Y60.6
ICD-10 code description
During aspiration, puncture and other catheterization
Primary outcomes
1
Description
The number of attempts for successful venipuncture
Timepoint
During the procedure
Method of measurement
Number
2
Description
The time required for successful venipuncture
Timepoint
During the procedure
Method of measurement
minute
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Needle (22 G) catheterizations. After general anesthesia, patients are placed in the Trendelenburg 30 position and after sterilizing the skin, catheterization is performed by a pediatric anesthetist or fellowship under ultrasound guidance. The primary site of choice for catheterization is the right internal jugular vein. In case of unsuccessful catheterization, it will be done in the left internal jugular vein.
Category
Treatment - Surgery
2
Description
Intervention group: Angiocath (22 G) catheterization. After general anesthesia, patients are placed in the Trendelenburg 30 position and after sterilizing the skin, catheterization is performed by a pediatric anesthetist or fellowship under ultrasound guidance. The primary site of choice for catheterization is the right internal jugular vein. In case of unsuccessful catheterization, it will be done in the left internal jugular vein.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Mofid Hospital
Full name of responsible person
Dr. Seyyed Alireza Mahdavi
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
4167811969
Phone
+98 912 151 1112
Email
alirezamahdavi@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
4167811969
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Mahdavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid Children's Hospital
City
Tehran
Province
Tehran
Postal code
15468 15514
Phone
+98 21 2222 7021
Email
alirezamahdavi@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Mahdavi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid Children's Hospital
City
Tehran
Province
Tehran
Postal code
15468 15514
Phone
+98 21 2222 7021
Email
alirezamahdavi@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Alireza Mahdavi
Position
Accossiate Professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Mofid Children's Hospital
City
Tehran
Province
Tehran
Postal code
1551415468
Phone
+98 21 2222 7021
Email
alirezamahdavi@sbmu.ac.ir
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
Regarding the ethical issues
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available