| CTRI Number |
CTRI/2025/07/090582 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of ultrasound guided vein cannulation in paediatric patients undergoing neurosurgery- A Pilot Study |
|
Scientific Title of Study
|
Comparison of ultrasound guided Brachiocephalic and Internal jugular vein cannulation in paediatric patients undergoing neurosurgery - A pilot study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhishm Barthwal |
| Designation |
Assistant professor |
| Affiliation |
Army Hospital (R&R) |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral
South West
DELHI
110010
India |
| Phone |
7300703246 |
| Fax |
|
| Email |
bhishm09642w@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhishm Barthwal |
| Designation |
Assistant Professor |
| Affiliation |
Army Hospital (R&R) |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral
South West
DELHI
110010
India |
| Phone |
7300703246 |
| Fax |
|
| Email |
bhishm09642w@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhishm Barthwal |
| Designation |
Assistant Professor |
| Affiliation |
Army Hospital (R&R) |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral
South West
DELHI
110010
India |
| Phone |
7300703246 |
| Fax |
|
| Email |
bhishm09642w@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Hospital Research and Referral, Delhi Cantt-110010 (Delhi) -India |
|
|
Primary Sponsor
|
| Name |
Army Hospital Research and Referral |
| Address |
Army Hospital Research and Referral, Delhi Cantt-110010 (Delhi)- India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhishm Barthwal |
Army Hospital (Research and Referral) |
Department of Anaesthesiology and Critical Care, second floor, Delhi Cantt, 110010 (Delhi)- India
South West
DELHI |
7300703246
bhishm09642w@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Army hospital research and referral, Delhi cantt |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C719||Malignant neoplasm of brain, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided in plane supraclavicular left brachiocephalic vein cannulation. |
To evaluate the success rate and time required for successful cannulation |
| Comparator Agent |
Ultrasound guided out of plane right Internal Jugular vein cannulation |
To evaluate the success rate and time required for successful cannulation |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients of both sexes, upto 12 years of age undergoing craniotomy, requiring central venous cannulation under general anaesthesia with controlled ventilation |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
a) To evaluate the success rate of ultrasound guided out of plane right IJV cannulation and in plane supraclavicular left brachiocephalic vein cannulation in paediatric patients undergoing neurosurgery
b) To compare the time required for successful cannulation between the two approaches |
Compare time required for successful cannulation between the two approach |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a) To assess the number of attempts required for successful cannulation
b) To compare the complication rates associated with each technique |
Compare the time required for cannulation between two approaches |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 1 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhishm09642w@gmail.com].
- For how long will this data be available start date provided 03-06-2027 and end date provided 03-06-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Central venous cannulation is an essential procedure in critically ill patients and for major surgeries for better hemodynamic monitoring and management. Ultrasound guided brachiocephalic vein cannulation in paediatric age group has become recently due to high success rate with less life- threatening complications. This is a prospective, randomized pilot study comparing ultrasound-guided in-plane supraclavicular left brachiocephalic vein cannulation with out-of-plane right internal jugular vein cannulation in paediatric patients undergoing neurosurgery. The primary aim is to compare first- attempt success rates and cannulation times. Secondary objectives include evaluating the number of attempts and complications. A total of 64 children will be enrolled ( 32 per group) at army hospital research and referral, Delhi cantt. Patients will be randomized post- induction of anaesthesia, and cannulation will be performed under ultrasound guidance using the modified seldinger technique. Outcomes will be recorded by an independent observer. The study will adhere to ethical guidelines with informed consent and assent as applicable. |