| CTRI Number |
CTRI/2022/09/046019 [Registered on: 29/09/2022] Trial Registered Prospectively |
| Last Modified On: |
24/03/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of new technique of ultrasound-guided central venous access in adult surgical patents. |
|
Scientific Title of Study
|
Dynamic needle tip positioning versus short axis technique for ultrasound-guided internal jugular venous cannulation in adult surgical patients: a randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NA |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NIRAJ KUMAR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no – 709
7th floor
Deptt of Neuroanesthesiology Critical Care
Neuroscience center
AIIMS Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9013770806 |
| Fax |
|
| Email |
drnirajaiims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NIRAJ KUMAR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no – 709
7th floor
Deptt of Neuroanesthesiology Critical Care
Neuroscience center
AIIMS Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9013770806 |
| Fax |
|
| Email |
drnirajaiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR NIRAJ KUMAR |
| Designation |
ADDITIONAL PROFESSOR |
| Affiliation |
AIIMS, NEW DELHI |
| Address |
Room no – 709
7th floor
Deptt of Neuroanesthesiology Critical Care
Neuroscience center
AIIMS Delhi-110029
New Delhi
DELHI
110029
India |
| Phone |
9013770806 |
| Fax |
|
| Email |
drnirajaiims@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 NIRAJ KUMAR |
AIIMS, NEW DELHI |
Room no – 709, 7th floor, Deptt of Neuroanesthesia and Critical Care Neurocenter AIIMS Delhi 110029
New Delhi
DELHI |
9013770806
drnirajaiims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dynamic needle tip positioning (DNTP) technique of IJV cannulation |
ultrasound-guided Dynamic needle tip positioning (DNTP) technique of IJV cannulation in adult ssurgical patients |
| Comparator Agent |
short-axis technique of IJV cannulation |
ultrasound- guided short-axis technique of IJV cannulation in adult surgical patients |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients (18 to 60 years old) with ASA classification I and II, undergoing general anaesthesia for elective neurosurgical procedure that require IJV catheterization will be included in this study |
|
| ExclusionCriteria |
| Details |
Patient will be excluded if they are Less than 18 or more than 60 years old, Hemodynamically unstable or shock (SBP less than 60 OR on vasoactive drugs), Having infection, inflammation, trauma and hematoma at the cannulation site, Having significant coagulopathy, Morbid obesity (BMI more than 40)
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate |
At the point of successful US-guided IJV cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Overall success rate
• No. of attempts
• No. of redirection
• Cannulation time
• Procedural time
• Incidence of complications (carotid artery puncture, PWVP, hematoma, pneumothorax haemothorax).
|
At the point of successful US-guided IJV cannulation |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2022 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Nil |
|
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
- 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 [drnirajaiims@gmail.com].
- For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2030?
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
|
This study is a randomized, double blind, parallel group, single-centre trial comparing the first attempt success rate between dynamic needle tip positioning (DNTP) versus short axis (SA) of ultrasound -guide IJV cannulation in adult surgical patients, that will be conducted in one center (AIIMS, New Delhi) in India. The primary outcome measures will be first attempt success rate. The secondary outcomes will be overall success rate, no. of attempts, no. of redirection, cannulation time, procedural time, incidence of complications (carotid artery puncture, PWVP, hematoma, pneumothorax and haemothorax) during ultrasound -guide IJV cannulation. |