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.: PACTR202105582607830 Date of Approval: 17/05/2021
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ultrasonographic Relationship Between Internal Jugular Vein And Common Carotid Artery In Infants After Tracheal Tube Versus Laryngeal Mask Airway
Official scientific title Ultrasonographic Relationship Between Internal Jugular Vein And Common Carotid Artery In Infants After Tracheal Tube Versus Laryngeal Mask Airway
Brief summary describing the background and objectives of the trial Central venous cannulation (CVC) through right internal jugular vein (IJV) route is usually performed when indicated in infants undergoing major surgery and in those admitted to intensive care units. Also In infants, general anaesthesia (GA) may be required for IJV cannulation, and supraglottic airway device (SGAD) can be used for maintaining the airway in anaesthetised infants. Overlapping of the common carotid artery (CCA) by the internal jugular vein (IJV) especially jeopardizes success and increases the complication rate in catheterization mainly by facilitating the puncture of CCA with inadvertent needle advancement. The use of ultrasound is accepted to be helpful to identify the relationship between the IJV and the CCA. We hypothesise that the airway device preference may affect anatomic relationship between internal jugular vein and common carotid artery. Also, head rotation can affect the degree of carotid artery overlap and the cross-sectional area of the right IJV. This aim of this study is to find the optimal degree of head rotation for IJV cannulation after endotracheal intubation (ETT) and laryngeal mask airway (LMA) insertion in infants and to examine the impact of the laryngeal mask insertion as a supraglottic device versus endotracheal intubation on the relationship between the CCA and the IJV in infants with the aid of ultrasound device.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Anaesthesia,Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 01/06/2021
Actual trial start date
Anticipated date of last follow up 31/08/2021
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Endotracheal Tube Images will be taken before and after insertion of endotracheal tube. An 8–12 MHz linear probe will be gently placed on the skin on the right side of the neck on both upper and lower levels with the least pressure in the neutral, 30°, 45° and 60° head away positions 60
Control Group Laryngeal mask airway Images will be taken before and after insertion of laryngeal mask airway. An 8–12 MHz linear probe will be gently placed on the skin on the right side of the neck on both upper and lower levels with the least pressure in the neutral, 30°, 45° and 60° head away positions 60 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Weight less than 10 kg American Society of Anesthesiologists physical status I or II registered to undergo elective surgery (with duration less than one hour in which we can use either endotracheal tube or LMA) regardless of whether central venous cannulation was planned or not Escorts refusal of the consent. Dehydration. Any contraindication to supraglottic device. History of central venous cannulation via the right IJV. The presence of cardiovascular anomalies. Thrombosis of the left or right IJV. Infants suffering of mediastinal mass. Known or suspected anatomic abnormalities of neck and/or thorax. Predicted or confirmed difficult airway. Infant: 13 Month(s)-24 Month(s) 1 Month(s) 12 Month(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 18/06/2020 The Ethics Committee of the Faculty of Medicine Alexandria University IRB No 00012098
Ethics Committee Address
Street address City Postal code Country
17 Champollion Street, El Messalah Alexandria 21521 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Optimal degree of head rotation for IJV cannulation after endotracheal intubation and laryngeal mask airway insertion in infant
Secondary Outcome The impact of airway device on the relationship between the CCA and the IJV in infants with the aid of ultrasound device After endotracheal intubation and laryngeal mask airway insertion in infant
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Inpatient of pediatric surgical department of Shatby Hospital Faculty of Medicine University of Alexandria Suez Canal Rd, Al Azaritah WA Ash Shatebi, Qism Bab Sharqi, Alexandria Governorate Alexandria 21526 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mohamed Ahmed Abd esalam Felifel 9 elwaziry street muharram bey Alexandria 21515 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Pediatric Surgical Department Suez Canal Rd, Al Azaritah WA Ash Shatebi, Qism Bab Sharqi, Alexandria Governorate Alexandria 21526 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Ramadan Abdel Azim Ammar 17 Champollion Street, El Messalah Alexandria 21521 Egypt
Tarek Mohamed Ahmed Sarhan 17 Champollion Street, El Messalah Alexandria 21521 Egypt
Ahmed Mohamed Ahmed Elshafie 17 Champollion Street, El Messalah Alexandria 21521 Egypt
Mohamed Ahmed Abd esalam Felifel 9 elwaziry street muharram bey Alexandria 21515 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ramadan Ammar RAMADAN.AMMAR@alexmed.edu.eg 00201223115881 17 Champollion Street, El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Scientific Enquiries Tarek Sarhan tmsarhan@yahoo.com 00201024933910 17 Champollion Street, El Messalah
City Postal code Country Position/Affiliation
Alexandria 21521 Egypt Professor of Anesthesia and Surgical Intensive Care Faculty of Medicine University of Alexandria
Role Name Email Phone Street address
Public Enquiries Elsayedamr Basma elsayedamr@yahoo.com 00201223106023 30 Garden City Smouha
City Postal code Country Position/Affiliation
Alexandria 21615 Egypt Patient Information Manager
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Full excel sheet of data will be available upon completing the recruitment Informed Consent Form,Study Protocol 1 year Open access will be permitted to get the data please send e-mail to elsayedamr@yahoo.com (public relation) Researchers decided to send data when requested No quality of request is required
URL Results Available Results Summary Result Posting Date First Journal Publication Date
N/A 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