A comparison of open vs ultrasound-guided percutaneous insertion of central venous catheter in children weighting five kilograms or less.
Design
This study is a randomized clinical trial (balanced (permuted) block randomization) with the participation of 100 patients, in parallel groups with phase 2 and without blinding.
Settings and conduct
100 patients will be randomly divided (balanced (permuted) block randomization) into two groups (50 people in each group). Patients will go to the operating room of the Children's Hospital (Tabriz-Iran) and a central vein catheter will be inserted for them by a pediatric surgeon. The first group will receive an open catheter and the second group will receive a catheter under an ultrasound guide. No blinding will be performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria included (1) weight less than 5 kg (2) required central venous catheter implantation (3) central venous catheter implantation for the first time, and (4) consent to participate in the research project and exclusion criteria also included (1) Patients with hemophilia (2) had an INR greater than 1.5 (3) platelet counts less than 100,000 (4) a history of CPR and (5) a history of coagulation disorders.
Intervention groups
Patients will be randomly divided (balanced (permuted) block randomization) into two groups. The first group (50 people) will receive a central venous catheter open and the second group (50 people) will receive a central venous catheter under ultrasound guidance.
Main outcome variables
Success rate in central venous catheter implantation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190325043107N19
Registration date:2020-11-06, 1399/08/16
Registration timing:prospective
Last update:2020-11-06, 1399/08/16
Update count:0
Registration date
2020-11-06, 1399/08/16
Registrant information
Name
Mehdi Khanbabayi Gol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3334 7054
Email address
khanbabayimehdi69@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-30, 1399/09/10
Expected recruitment end date
2022-03-01, 1400/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of open vs ultrasound-guided percutaneous insertion of central venous catheter in children weighting five kilograms or less.
Public title
Central vein catheter implantation in children
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Weight less than 5 kg
Requires central venous catheter placement
First insertion of a central venous catheter
Consent to participate in the research project
Exclusion criteria:
Patients with hemophilia
INR rate greater than 1/5
Platelet count less than 100,000
CPR history
History of coagulation disorders
Age
From 1 year old to 3 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be divided into two groups by random allocation method. The balanced (permuted) block randomization will be used for random allocation and patients will be divided into two groups of intervention and placebo; Thus, first 6 possible modes of blocks (BAAB, ABBA, BABA, AABB, ABAB, BBAA) were listed and each block was assigned a number from 1 to 0. Then, a number between 1 and 0 was randomly selected and the subjects were assigned to the experimental group (A) and placebo (B) based on the relevant block and the selected number.
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
Ethics committee of Tabriz University of Medical Sciences
Street address
Children Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Approval date
2019-12-23, 1398/10/02
Ethics committee reference number
IR.TBZMED.REC.1398.1015
Health conditions studied
1
Description of health condition studied
The rate of infection in pediatric central venous catheter implantation
ICD-10 code
T80.21
ICD-10 code description
Infection due to central venous catheter
Primary outcomes
1
Description
The rate of infection in pediatric central venous catheter implantation
Timepoint
Once daily for up to three days after catheter placement
Method of measurement
Clinical examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will go to the operating room. Using a linear probe , the internal jugular vein is found and then the needle is inserted into the vein. After making sure that the needle is inside the vein and reads it, the guide wire enters the lumen of the left internal jugular vein through the needle. In this case, the presence of a guide wire in the internal jugular vein can also be confirmed by ultrasound. The needle is then removed but the guide wire remains inside the vein. Using a dilator, the path is cannulated through the guide wire. After this step, the dilator is removed and the central vein catheter is inserted into the internal jugular vein through the guide wire. After making sure that the catheter is inside the vein, the guide wire is removed and the catheter will be fixed on the skin using sutures.
Category
Treatment - Surgery
2
Description
Control group: Patients will enter the operating room. A small incision is made in the neck and the internal jugular vein is dissected and controlled, and a separate 5 mm long incision is made in the vein through which the central vein catheter is inserted without the use of a guidewire and under direct view through A venotomy is inserted, then repaired and fixed with an absorbable suture, and then the vein is repaired.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Childrens Hospital
Full name of responsible person
Saed Aslanabadi
Street address
Azadi Ave, Childrens Hospital
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3535 3696
Email
Salanabadi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban
Street address
Children Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165665631
Phone
+98 41 3335 7310
Email
Ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
50
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
Tabriz University of Medical Sciences
Full name of responsible person
Ibrahim Farhadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Childrens Hospital, Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ibrahim Farhadi
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Childrens Hospital, Sheshgelan Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Khanbabayi Gol
Position
MSc in Nursing Education
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Imam Reza Hospital, Azadi Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5981764863
Phone
+98 41 3334 7054
Fax
Email
Khanbabayimehdi69@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
There is no more information
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