Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201711002750241 Date of Approval: 07/11/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Techniques of internal jugular vein cannulation in infants
Official scientific title Ultrasound-guided Thin-wall Needle Technique vs Cannula-over-needle Technique in Internal Jugular Vein Catherization in Infants
Brief summary describing the background and objectives of the trial Internal jugular vein (IJV) is the most common site for central venous catheter (CVC) insertion in pediatric cardiac surgery, with a lower success rate than adults due to small size of pediatric IJV. Two techniques have been used for needle insertion and guidewire placement during central venous catheterization, a thin-wall introducer needle technique (TWN) (Seldinger) and a cannula-over-needle technique (CON) (modified Seldinger). the objective is To compare between the thin-wall introducer needle technique and a cannula-over-needle technique for insertion of IJV ventral venous catheter in infants in terms of success, number of attempts, catheter insertion time and complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cardiology,Circulatory System,congenital heart disease
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 14/11/2017
Actual trial start date
Anticipated date of last follow up 14/02/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised computer software program sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ULTRASOUND-GUIDED THIN-WALL NEEDLE TECHNIQUE VERSUS CANNULA-OVER-NEEDLE TECHNIQUE IN INTERNAL JUGULA success within 7 attempts Central venous catheterization was performed on the right internal jugular vein under assistance with real-time ultrasonography. Needle insertion and guidewire placement were performed using a thin-wall introducer needle technique in the thin-wall introducer needle group and a cannula-over-needle technique in the cannula-over-needle group. 60
Control Group ULTRASOUND-GUIDED THIN-WALL NEEDLE TECHNIQUE IN INTERNAL JUGULAR VEIN Central venous catheterization was performed on the right internal jugular vein under assistance with real-time ultrasonography. Needle insertion and guidewire placement were performed using a thin-wall introducer needle technique in the thin-wall introducer needle group. 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
infants less than one year scheduled for elective cardiac surgery inflammation at the catheter insertion site, previous neck surgery, anatomical variation of neck vessels, previous right-side central venous catheterization within one month. 1 Week(s) 1 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/10/2017 alexandria medical ethics committee
Ethics Committee Address
Street address City Postal code Country
alkhartoom square, elazarita street alexandria 21514 Egypt
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/10/2017 alexandria medical ethics committee
Ethics Committee Address
Street address City Postal code Country
alkhartoom square, elazarita street alexandria 21514 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare between the thin-wall introducer needle technique and a cannula-over-needle technique for insertion of IJV ventral venous catheter in infants in terms of success, number of attempts. start of anaesthesia
Secondary Outcome catheter insertion time and complications start of anaesthesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
alexandria faculty of medicine al khartoom square, elazarita alexandria 21514 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
alexandria faculty of medicine alkhartoom square, alazarita street alexandria 21514 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor alexandria faculty of medicine al khartoom square, elazarita alexandria 21514 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Amr Elsayed Hashem miamy alexandria 21616 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohamed Okasha dr.okasha88@gmail.com 00201004259282 smuha
City Postal code Country Position/Affiliation
alexandria 21523 Egypt demonstrator
Role Name Email Phone Street address
Public Enquiries ibrahim mabrouk ibrahim_wama@hotmail.com 00201224336786 eldekhila
City Postal code Country Position/Affiliation
alexandria 21517 Egypt assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries amr hashem amr.s.hashem74@gmail.com 00201065527753 miamy
City Postal code Country Position/Affiliation
alexandria 21616 Egypt lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information