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.: PACTR202101771187923 Date of Approval: 27/01/2021
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Single operator versus two operators in ultrasound guided central venous access in neonates and infants
Official scientific title Single operator versus two operators in ultrasound guided central venous access in neonates and infants
Brief summary describing the background and objectives of the trial In recent years, several studies have encouraged the use of ultrasonography as a safe and efficient technique to assist in the venous detection and central line insertion. US guided puncture of central vein for the implantation of venous catheter system is faster by reducing procedure time; it is easier for the operator and safer for the patient than blind technique by exposing anatomical structures. Moreover US guidance reduces early complications and limits costs. The hypothesis is that two operators is superior to single operator in of ultrasound assisted central venous access in neonates and infants
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Circulatory System,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/09/2020
Actual trial start date 26/09/2020
Anticipated date of last follow up 31/03/2021
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status 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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using by using procedures such as coin-tossing or dice-rolling Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group single operator 1h The anesthesiologist will insert the CVC needle with one hand and hold the US probe with the other hand. 50 Active-Treatment of Control Group
Experimental Group two operator 1h One anesthesiologist will hold the US probe, while another anesthesiologist will insert the CVC needle. 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
aged less than 2 years both genders need for central line insertion • Refusal of their guardians • Pervious central venous cannulation, • Coagulopathy or bleeding disorders, • History of failed vein cannulation • Occurrence of any mechanical complication during the failed trial, • Local infection at the site of puncture, • distorted anatomy of the clavicle or the neck, underlying pleural effusion or pneumothorax and • After 3 attempts of the skin puncture with the introducing needle. Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,New born: 0 Day-1 Month 0 Month(s) 2 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 25/09/2020 medical research ethics committe faculty of medicine mansoura university
Ethics Committee Address
Street address City Postal code Country
2 el Gomhurria st. elmansora 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome • The first successful needle puncture attempt to approach 1h
Secondary Outcome • The number of skin puncture attempts • The number of failed CVC insertion, • The time that was taken to puncture the vein and to insert CVC and • The rate of mechanical complications. As arterial puncture, nerve injury, pneumothorax…etc. 1h
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
mansoura university children hospital 2 elgomhurria st. elmansnoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor faculty of medicine mansoura university 2 elgomhurria st. Mansoura 35516 Egypt University
COLLABORATORS
Name Street address City Postal code Country
ibrahim ibrahim abdelbaser 2 elgomhurria st Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator mohamed ahmed maher ibrahim elmorsy m.am.elmorsy@gmail.com +201112582480 2 el gomhuria st
City Postal code Country Position/Affiliation
el mansoura 35516 Egypt lecturer of anesthesia and surgical ICU
Role Name Email Phone Street address
Public Enquiries ibrahim ibrahim abdelbaser ibrahimbaser2010@yahoo.com +21004976825 2 el gomhuria st
City Postal code Country Position/Affiliation
el mansoura 35516 Egypt assistant professor of anesthesia and surgical ICU
Role Name Email Phone Street address
Scientific Enquiries Nabil Abd Elraouf Abd Elmageed Nabil_abdelraouf@yahoo.com +201001538648 2 el gomhuria st.
City Postal code Country Position/Affiliation
el mansoura 35516 Egypt professor of anesthesia and surgical ICU
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Non identified patients data will be available in excel sheets with the principle investigator for 6 months after publication of the paper Informed Consent Form,Statistical Analysis Plan,Study Protocol Documents will be available within 6 months after publication of the paper. Open access to IPD to reviewers. Data will be send directly by email upon request m.am.elmorsy@gmail.com
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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