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.: PACTR201509001229209 Date of Approval: 10/08/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Comparing out of plane versus in-plane ultrasound views for internal jugular vein cathterization
Official scientific title Comparing out of plane versus in-plane ultrasound views for internal jugular vein cathterization
Brief summary describing the background and objectives of the trial Comparing out of plane versus in-plane short axis views for internal jugular vein cathterization
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied venous access
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/08/2015
Actual trial start date 31/10/2015
Anticipated date of last follow up 02/08/2015
Actual Last follow-up date 31/10/2015
Anticipated target sample size (number of participants) 60
Actual target sample size (number of participants) 60
Recruitment status Stopped early/ terminated
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 randomisation using a randomisation table from a statistics book Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group ultrasound guided out of plane short axis view 10-15 linear ultrasound probe before start of operation till patient discharge to ward ultrasound guided out of plane short axis view 30
Experimental Group ultrasound guided in -plane short axis view 10-15 linear ultrasound probe before start of operation till patient discharge to ward ultrasound guided in-f plane short axis view 30
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
patients admitted to surgeries requiring central venous catheter insertion sepsis at site of entry coagulopathy mass at site of entry 40 Year(s) 60 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
No medical research institute
Ethics Committee Address
Street address City Postal code Country
165 horreya road Alexandria 21561 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome cannulation sucess within 2 minutes
Secondary Outcome number of cannulation attempts withdrawing the needle followed by another skin puncture, is defined as a new cannulation attempt
Secondary Outcome redirection attempts withdrawing the needle followed by redirecting it within the same skin puncture is defined as a redirection attempt
Secondary Outcome cannulation time within 120 seconds from skin puncture to viewing catheter inside vessel
Secondary Outcome complications measured during the process of cannulation
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
medical research institute 165 horreya road Alhadara-Alexandria Alexandria 21561 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
medical research institute 165 horreya road Alhadara-Alexandria Alexandria 21561 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor medical research institute 165 horreya road Alhadara-Alexandria Alexandria 21561 Egypt University
COLLABORATORS
Name Street address City Postal code Country
medical research institute 165 horreya road Alhadara-Alexandria Alexandria 21561 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Sherif Abdelhamid dr_shereif@hotmail.com 01001459756/002 165 horreya road Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anesthesia and surgical intensive care-Alexandria university
Role Name Email Phone Street address
Public Enquiries mohamed ellakany mlakany@yahoo.com 01001459756/002 165 horreya road Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anesthesia and surgical intensive care-Alexandria university
Role Name Email Phone Street address
Scientific Enquiries Sherif Abdelhamid dr_shereif@hotmail.com 01001459756/002 165 horreya road Alhadara
City Postal code Country Position/Affiliation
Alexandria 21561 Egypt lecturer of anesthesia and surgical intensive care-Alexandria university
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information