| CTRI Number |
CTRI/2023/09/057978 [Registered on: 22/09/2023] Trial Registered Prospectively |
| Last Modified On: |
26/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison of placement of cathethar into a large vein(Internal jugular vein ans brachiocephalic vein) usually around neck using ultrasound in neonates and infants |
|
Scientific Title of Study
|
Comparison of Ultrasound guided Brachiocephalic and internal jugular vein cannulation in neonates and infants:A prospective randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Raylene Dias |
| Designation |
Assistant Professor and Incharge;Department of pediatric anesthesia;KEM Mumbai |
| Affiliation |
Seth GS medical college and KEM Hospital Mumbai. |
| Address |
Department of paediatric anesthesia ,3 rd floor old building Seth GS medical College and KEM Hospital Mumbai
607 B sea flama B wing dosti famingo sewri ,mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
09930608191 |
| Fax |
|
| Email |
raylene.dias@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Raylene Dias |
| Designation |
Assistant Professor and Incharge;Department of pediatric anesthesia;KEM Mumbai |
| Affiliation |
Seth GS medical college and KEM Hospital Mumbai. |
| Address |
Department of Paediatric Anaesthesia,3 rd floor old building ,seth GS medical college and KEM hoapital Mumbai
MAHARASHTRA
400012
India |
| Phone |
09930608191 |
| Fax |
|
| Email |
raylene.dias@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raylene Dias |
| Designation |
Assistant Professor and Incharge;Department of pediatric anesthesia;KEM Mumbai |
| Affiliation |
Seth GS medical college and KEM Hospital Mumbai. |
| Address |
Department of paediatic Anaesthesia,3 rd floor old building seth GS medical college and KEM Hospital Mumbai.
MAHARASHTRA
400012
India |
| Phone |
09930608191 |
| Fax |
|
| Email |
raylene.dias@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of pediatric anaesthesia(3 rd floor old building -paediatric OT) Seth GS medical college and KEM Hospital Mumbai. |
|
|
Primary Sponsor
|
| Name |
Seth GSmedical college and KEM Hospital Mumbai |
| Address |
Department of Pediatric anesthesia ,Seth GS Medical college and KEM Hospital mumbai |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Institution KEM hospital mumbai |
Seth GS medical college KEM hospital mumbai |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr uditi parmar |
Seth GS medical College and KEM Hospital Mumbai |
department of pediatric anesthesia 3 rd floor old building paediatric OT
Mumbai
MAHARASHTRA |
7869865207
uditsa7411@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe (IEC)-1for clinical trial,bioavailability and bioequivalence study and relating to biomedical and health research(BHR) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Neonates and infants with congenital anomaly ,With respiratory infection,abdominal surgical emergencies |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided left brachiocephalic vein cannulation |
comparison of 1 st attempt success rate,cannulation time,cannulation attempts,overall success rate and complications |
| Comparator Agent |
Ultrasoung guided right IJV cannulation |
1 st attempt success rate,cannulation time,cannulation attempts ,overall success rate and complicatios. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
A total of 80 patients of both sexes ,neonates(including low birth weight) and infants upto 1 year of age requiring central venous cannulation under general anesthesia with controlled ventilation as a part of their routine medical care were included in the study |
|
| ExclusionCriteria |
| Details |
. Infection at the site of insertion
2.uncorrected severe coagulopathy (platelet count<50,000),on anticoagulant or antiplatelet medications.
3. Patients with hemodynamic instability intolerant to general anaesthesia.
4. known venous thrombosis of vessel
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare ultrasound guided in plane right IJV cannulation with & in plane supraclavicular left brachiocephalic vein cannulation with respect to the first attempt success rate .
|
the first attempt success rate ,overall success rate ,cannulation time noted at baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare Ultrasound guided in plane right IJV & in plane supraclavicular left brachiocephalic vein cannulation with respect to overall success rate, cannulation time & complications |
Any complication occuring with in 48 hours of cannulation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
30/09/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
COMPARISON OF ULTRASOUND GUIDED BRACHIOCEPHALIC AND INTERNAL JUGULAR VEIN CANNULATION IN NEONATES AND INFANTS:A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL recently an supraclavicular brachiocephalic vein cannulationhas emerged as newer approach with several advantages specially in difficult situations.However,to date there are only few studies comparing ultrasound guided in plane brachiocephalic vein cannulation to other approaches in pediatric patients and therefore a well designed randomized trials are warranted as most of the available data comes from non randomized studies,case series and case reports.The purpose of thid study is to compare USG guided in plane IJV vs supraclavicular in plane brachiocephalic vein cannulation. MATERIAL AND METHODS:A total of 80 neonates and infants satisfying the inclusion criteria will be randomly alloted into one of the two groups(group A or Group B).After anesthesia induction,in group A for IJV cannulation,standord longitudinal in plane approach will be used and in group B Ultrasound guided left brachiocephalic vein cannulation will be done.The study parameters will be recorded by independent observor and will include the 1 st attempt success rate,cannulation time,number of cannulation attempts ,overall success and complications if any.On completion of procedure,furthur maintenance and subsequent anesthesia recovery would be as per anesthesiologist incharge. STATISTICAL ANALYSIS:The data will be collected,compiled and analysed using EPI info.The qualitative variables will be expressed in terms of percentages.The quantitative variables will be categorised ad expressed in terms of percentages or mean and standord deviations.For normal data,difference between two groups will be analysed using paired or unpaired student t test.For non normal data,Mann whitney U test will be used.The difference between two proportion will be analysed usingchie -square or fisher exact test.All analysis will be two tailed ,and the significance level will be set at 0.05. |