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.: PACTR201909663728514 Date of Approval: 20/09/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasound guided central axillary vein catheterization in pediatric cardiac surgery
Official scientific title Ultrasound guided central axillary vein catheterization :- is it a good alternative to internal jugular vein in pediatric cardiac surgery?
Brief summary describing the background and objectives of the trial Insertion of a central venous catheter (CVC) into a central vein is a routine maneuver in children submitted for cardiac surgery. This procedure may be technically difficult in pediatric specially infants and neonates and may be associated with serious complications. Children undergoing cardiac surgery are usually small sized neonates and infants and any complications related central venous catheter placement such as iatrogenic pneumothorax, can be challenging. In addition, these patients will be fully anticoagulated with heparin before going on cardiopulmonary bypass, so inadvertent arterial puncture may complicate the perioperative course. CVC is most frequently inserted into internal jugular vein (IJV). Ultrasound (US) guidance is now used routinely for insertion of the central venous catheter (CVC) into the internal jugular vein (IJV). The subclavian vein (SCV) is a used as an alternative to the IJV despite of its serious complications. localization of subclavian vein by ultrasound is difficult. Anatomically, the axillary vein becomes the subclavian vein as it crosses the lateral border of the first rib and its imaging by US is much more easy than the subclavian vein. Ultrasound guided axillary vein (AXV) cannulation has been shown to be an useful and reliable technique for insertion of the central venous catheters which placed into the infraclavicular region and not the axilla. US guided axillary vein cannulation have many benefits compared to subclavian vein which include, effective control of bleeding in case of inadvertent arterial puncture by direct external compression, lower risk of pneumothorax, hemothorax, and chylothorax as the vein puncture is extrathoracic. The current study will compare the rate of success and complications of ultrasound guided IJV and AXV cannulation in pediatric cardiac surgery. The primary goal of this randomized study is to compare the first attempt success rate of these two approaches while the secondary goal is to compare the rate of mechanical complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 15/10/2019
Actual trial start date 15/12/2019
Anticipated date of last follow up 01/11/2021
Actual Last follow-up date 01/12/2021
Anticipated target sample size (number of participants) 320
Actual target sample size (number of participants) 320
Recruitment status Completed
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 Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Central axillary vein catheterization Ultrasound guided central axillary vein catheterization After induction of anesthesia For axillary vein cannulation, the US probe will be placed in the sagittal plane just below the middle third of the clavicle with probe mark toward the patient head. The US probe will be moved laterally very slowly till visualization the axillary vein and artery by short axis view. The vein can be differentiated from the artery as it is compressible, larger, not pulsating, oval while the artery is circular and finally by the colour doppler. The US probe will be rotated 90 degree to get a long axis view of AXV, the introducer needle will be advanced inan in plane technique at 45 degree to the skin under the linear probe which provide a long view to the axillary vessels, the needle tip will be seen compressing the vein wall and then puncturing it as its confirmed by aspiration of non pulsating dark blood, then the guide wire will be introduced through the needle and over it a plastic dilator will introduced followed by insertion of double or triple lumen CVC of appropriate size double (4F,5F or 5.5F)French at a depth 5 to 8cm. 160
Control Group Control group Ultrasound guided Internal jagular vein (IJV) catheterization After induction of anesthesia The patient will be placed supine with 15 degree head down position with appropriate extetnsion of the neck by placing a shoulder roll between the 2 scapulae and the head slightly rotated to the contralateral side with the arm abducted 45 degree. Complete aseptic precautions will be taken by using sterillium and isolating the area of CVC insertion with sterile drapes. IJV will be visualized using the high frequency linear vascular probe of echocardiography machine (GE, S5 ) at frequency 12-13 hz by short axis technique after its sterization with sterillium. The linear probe will be placed at apex of the triangle formed by the 2 heads of sternoclidomastoid and clavicle perpendicular to IJV and internal carotid artery. The introducer needle will be advanced 45 degree to the skin under the linear probe, the needle tip will be seen compressing the vein wall and then puncturing it as its confirmed by aspiration of non pulsating dark blood, then the guide wire will be introduced through the needle and over it a plastic dilator will introduced followed by insertion of double or triple lumen CVC of appropriate size double (4F,5F or 5.5F)French at a depth 5 to 8cm. Any changes in mean arterial pressure, heart rate and rhythm during CVC insertion will be observed. 160 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1-Children of either sex 2- Age ranging 1 mont to 12 years 3- Elective on pump cardiac surgery 1-History of failed vein cannulation 2-Occurrence of any mechanical complication during the failed trial 3-Local infection at the site of puncture 4-Coagulopathy or bleeding disorders 5-Distorted anatomy of the clavicle or the neck 6-Underlying pleural effusion or pneumothorax 7- After 3 attempts of the skin puncture with the introducing needle Child: 6 Year-12 Year,Infant: 0 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 1 Month(s) 12 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 28/08/2019 Mansoura Faculty of Medicine Institutional Research 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 The first attempt success rate It will be measured after induction of anesthesia
Secondary Outcome 1-The number of attempts, only 3 consecutive skin punctures will be allowed after which the patients will be excluded from the study. 2- Total time that will be taken to insert CVC. 3-Mechanical complications :- A-Arterial puncture which will be identified by the back flow of pulsating blood, presence of hematoma, or the arterial wave after connecting the CVC to the transducer B- Pneumothorax which will be identified after stenotomy 4- Puncture time in seconds 5- Catheter malposition, any position other than superior vena cava or right atrium which will be identified by the surgeon after sternotomy 6- Catheter occlusion after sternal retraction They will be measured after opening the chest via median sternotomy
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university children hospital Mansoura University, 2 El-Gomhouria Street, Mansoura 35516, Egypt. 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
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
Role Name Email Phone Street address
Scientific Enquiries Nabil Abd El raouf nabil_abdelraouf@yahoo.com +20100491538648 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Professor of anesthesia and surgical Intensive care
Role Name Email Phone Street address
Public Enquiries Hani Taman hani_taman@yahoo.com +201008288242 2 El-Gomhouria Street
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Lecturer of anesthesia and surgical intensive care
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes We will individual participate data and share it through the PubMed indexed journal Informed Consent Form,Study Protocol Beginning 12 months and ending 36 months following article publication We will individual participate data and share it through the PubMed indexed journal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
PubMed indexed journal 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