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.: PACTR202005873888902 Date of Registration: 22/05/2020
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Long axis versus short axis ultrasound guided femoral artery catheterization in neonates and infants
Official scientific title Long axis versus short axis ultrasound guided femoral artery catheterization in neonates and infants
Brief summary describing the background and objectives of the trial Continuous and real-time blood pressure (BP) monitoring through an arterial catheter is frequently used to optimize a patient’s hemodynamics in the operating theatre and the ICU. However, arterial catheterization is often challenging, especially in infants under 12 months of age (Ueda K, et al. 2013). Moreover, repeated failed attempts can cause arterial spasm or haematoma, making successful arterial catheterization even more difficult (Staniloae CS, et al 2009). Several recent studies have shown that guidance by realtime two-dimensional ultrasound, which has been shown clearly to be effective for the placement of a central venous catheter, (Augoustides JG, et al. 2005, Milling TJ Jr, et al. 2005, Hosokawa K, et al. 2007) improves the first-pass success rate in radial arterial catheterization in both adult and pediatric patients (Gao YB, et al. 2015). However, there are few randomized and controlled trials that demonstrate the usefulness of ultrasound guidance in the placement of an arterial catheter in an infant population (Schwemmer U,et al.2006, Ishii S, et al. 2013). Because infants are generally considered to be the most difficult population for arterial catheterization, (Ueda K, etal. 2013) the usefulness of an ultrasound-guided technique should also be evaluated in this group. Aim of the work and hypothesis We hypothesized that the long axis ultrasound-guided femoral arterial catheterization will be more effective than the short axis technique in neonate and infants under 12 months of age. The primary aim of the study will be the comparison of the first-pass success rate between long and short axis ultrasound-guided femoral arterial catheterization in neonates and infants undergoing elective cardiac surgery.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 30/05/2020
Actual trial start date 30/05/2020
Anticipated date of last follow up 30/12/2020
Actual Last follow-up date 20/01/2021
Anticipated target sample size (number of participants) 126
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL DOI:https://doi.org/10.1053/j.jvca.2021.05.036
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Palpation The arterial catheter will be inserted into the femoral artery guided by palpation. After induction of anesthesia The arterial catheter will be inserted into the femoral artery guided by palpation. 42 Active-Treatment of Control Group
Experimental Group Short Axis The arterial catheter will be inserted into the femoral artery guided by short axis ultrasound technique. After induction of anesthesia The arterial catheter will be inserted into the femoral artery guided by short axis ultrasound technique. 24
Experimental Group Long Axis The arterial catheter will be inserted into the femoral artery guided by long axis ultrasound technique. After induction of anesthesia The arterial catheter will be inserted into the femoral artery guided by long axis ultrasound technique. 42
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
neonates infants elective cardiac surgery. refusal of their guardians coarctation of aorta hypoplastic aortic arch redo cardiac surgery local infection of the skin and subcutaneous tissue at the site of needle puncture coagulation disorders renal, hepatic or pulmonary disease, heart failure moderate to severe pulmonary hypertension. Infant: 0 Month(s)-12 Month(s),New born: 0 Day-1 Month 1 Day(s) 365 Day(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 12/04/2020 Mansoura Faculty of Medicine Institutional Review Board
Ethics Committee Address
Street address City Postal code Country
2 El-Gomhouria Street Mansoura 35516 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome comparison of the first-pass success rate between long and short axis ultrasound-guided femoral arterial catheterization in neonates and infants undergoing elective cardiac surgery. After induction
Secondary Outcome Any complications during the procedures (e.g. hematoma formation, arterial spasm or ischemic signs) will be also documented just after femoral arterial catheterization. perioperative period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university children hospital 2 El-Gomhouria Street Mansoura 35516 Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Ibrahim Ibrahim Abd Elbaser 2 El-Gomhouria Street Mansoura 35516 Egypt
Nabil Abd El raouf Abd El mageed 2 El-Gomhouria Street Mansoura 35516 Egypt
Mohamed Maher El Morsy 2 El-Gomhouria Street Mansoura 35516 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ibrahim Abd Elbaser ibrahimbaser2010@yahoo.com +201004976825 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
Role Name Email Phone Street address
Public Enquiries Nabil Abdelraouf nabil_abdelraouf@yahoo.com +201001538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care at faculty of medicine Mansoura university
Role Name Email Phone Street address
Scientific Enquiries Mohamed Elmorsy dr.sevo.anesthesia@gmail.com +201112582480 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of Anesthesia and Surgical Intensive Care at Mansoura University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will provide individual participant data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Beginning 6 months and ending 12 months following article publication We will provide individual participant data and share it through the PubMed indexed journal
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