| CTRI Number |
CTRI/2018/12/016762 [Registered on: 21/12/2018] Trial Registered Prospectively |
| Last Modified On: |
21/12/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Analytical Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Influence of expertise of anaesthesiologist in various domains with respect to securing a catheter/tube in large vein using ultrasound |
|
Scientific Title of Study
|
Influence of operator characteristics and different approaches on successful ultrasound guided central venous cannulation in paediatric patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nandini Dave |
| Designation |
Additional Professor |
| Affiliation |
Seth GSMC and KEM Hospital Mumbai |
| Address |
Paediatric OT, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012
Mumbai MAHARASHTRA 400012 India |
| Phone |
9819392094 |
| Fax |
|
| Email |
nandinidave@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Nandini Dave |
| Designation |
Additional Professor |
| Affiliation |
Seth GSMC and KEM Hospital Mumbai |
| Address |
Paediatric OT, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012
MAHARASHTRA 400012 India |
| Phone |
9819392094 |
| Fax |
|
| Email |
nandinidave@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Nandini Dave |
| Designation |
Additional Professor |
| Affiliation |
Seth GSMC and KEM Hospital Mumbai |
| Address |
Paediatric OT, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012
MAHARASHTRA 400012 India |
| Phone |
9819392094 |
| Fax |
|
| Email |
nandinidave@gmail.com |
|
|
Source of Monetary or Material Support
|
| Self funded by the Department of Paediatric Anaesthesia, 3rd floor Old Building, Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012 |
|
|
Primary Sponsor
|
| Name |
Department of Paediatric Anaesthesia |
| Address |
Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Swarup Ray |
Seth GSMC and KEM Hospital Mumbai |
Paediatric OT, 3rd floor, Old Building Seth GSMC and KEM Hospital, Acharya Donde Marg, Parel, Mumbai, Maharashtra 400012 Mumbai MAHARASHTRA |
9886100987
swarupswarupswarup@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) II KEM Hospital Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
|
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Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Paediatric patients less than 12 years requiring central venous catheterisation under general anaesthesia |
|
| ExclusionCriteria |
| Details |
Children with any contraindication to central line placement such as coagulopathy, platelet count <50,000/mm3, on antiplatelet or anticoagulant medications |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare operator characteristics including anaesthesiologist experience, experience in paediatric anaesthesia, experience in paediatric central lines, experience in ultrasound guided lines and experience in a particular approach to central venous cannulation with success rate of line placement |
After guidewire insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare various operator characteristics with respect to number of attempts, complications and time required for central venous cannulation |
After guidewire insertion |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "120"
Final Enrollment numbers achieved (India)="120" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/01/2019 |
| Date of Study Completion (India) |
04/09/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
04/09/2019 |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Central venous cannulation remains a mainstay procedure used in the treatment of critically ill patients as well as patients coming for major surgeries. Ultrasound guidance has improved the safety level of this procedure. However, successful line placement would vary between different operators with different experience as well as different approaches. The exact nature of these differences is unclear and yet to be defined in the paediatric population. Understanding the nature of these relationships can help define practices which would further enhance the safety and success rate of this procedure. So the aim of this study would be to investigate the various operator related factors to different approaches of central venous cannulation in children below 12 years. We want to include children below 12 years requiring central venous catheterisation under general anaesthesia. Children with any contraindication to central line placement such as coagulopathy, platelet count <50,000/mm3, on antiplatelet or anticoagulant medications would be excluded. It will be a prospective analytical study for a period of 1 year. Written informed consent will be obtained prior to the procedure from the parents. Different operators (with more than 3 years experience in anaesthesiology and who have placed more than 50 central lines) would perform central venous cannulation. Selection of operators and approach would be non-randomised and depend on the consultant anaesthesiologist and operator themselves.The primary outcome measure would be to compare operator characteristics like anaesthesiologist experience, experience in paediatric anaesthesia, experience in paediatric central lines, experience in ultrasound guided lines and experience in a particular approach to central venous cannulation with respect to success rate of line placement, number of attempts, time taken for line placement and complications. Secondary outcomes would be to compare different approaches to central venous cannulation with respect to success rate, number of attempts, complications, time for cannulation as well as to compare success rate, number of attempts, complications, time for cannulation with respect to patient age, weight, as well as anaesthetic technique. The SPSS 24.0. software will used for statistical analysis of data of this study. Chi-square test will be used to test the association of different study variables and t-test will used to compare the means. Significance level will set at ≤0.05. |