| CTRI Number |
CTRI/2019/02/017491 [Registered on: 06/02/2019] Trial Registered Prospectively |
| Last Modified On: |
21/06/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Localisation of central vein using ultrasound for ease of venous line placement |
|
Scientific Title of Study
|
Pre-procedural Ultrasound for IJV Access- a pilot study |
| Trial Acronym |
PUJA study |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| version 1.2, Date-10/11/2018 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sumantra Sarathi Banerjee |
| Designation |
Clinical Associate |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Department of Anaesthesia, critical and Pain,14 MAR(E-W), New Town, Rajarhat, Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
8017182896 |
| Fax |
|
| Email |
dr.sumantra12@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sumantra Sarathi Banerjee |
| Designation |
Clinical Associate |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Department of Anaesthesia, Critical care and Pain, 14 MAR(E-W), New Town, Rajarhat, Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
8017182896 |
| Fax |
|
| Email |
dr.sumantra12@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sumantra Sarathi Banerjee |
| Designation |
Clinical Associate |
| Affiliation |
Tata Medical Center, Kolkata |
| Address |
Department of Anaesthesia, Critical care and Pain, 14 MAR(E-W), New Town, Rajarhat, Kolkata
Kolkata
WEST BENGAL
700156
India |
| Phone |
8017182896 |
| Fax |
|
| Email |
dr.sumantra12@gmail.com |
|
|
Source of Monetary or Material Support
|
| Tata Medical Center, Kolkata |
|
|
Primary Sponsor
|
| Name |
Sumantra Sarathi Banerjee |
| Address |
Saptabarna Apartment, G-12, Rabindrapally, Jyangra, Baguihati, Kolkata |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sumantra Sarathi Banerjee |
Tata Medical Center |
Operation Theatre, Department of Anaesthesia, Critical care and Pain, 14MAR(E-W), New Town, Rajarhat, Kolkata, West Bengal, 700156
Kolkata
WEST BENGAL |
8017182896
dr.sumantra12@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Tata Medical Center-Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Undergoing elective operation |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Any major surgery requiring Internal Jugular vein cannulation.
2. ASA grade I, II and III.
3. BMI: 18 to 30
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Cental venous cannulation through other routes
3. Local infection at the cannulation site.
4. Platelet deficiency (count <50,000)/ coagulopathy
5. Short neck
6. Patients posted for emergency surgery
7. Patients with COPD/ Asthma
8. Patients on multiple vasopressors/ hemodynamically unstable patients
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The actual time for which the ultrasound machine will be engaged for the cannulation of a single patient. |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of re-directions in this new approach
2. Number of re-insertions in this new approach.
3. Complications if any, with this technique
|
4 months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/02/2019 |
| Date of Study Completion (India) |
09/11/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Preparing for publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This is a pilot study where we will study 100 patients who will be posted for major surgery under general anaesthesia and will be requiring IJV cannulation. After induction of general anaesthesia the patient will be positioned in the usual manner for IJV access. The point of insertion of IJV cannula will be marked by one of the investigators using the ultrasound machine and normal saline in a syringe. The cannula insertion will then be done following the mark without the ultrasound. He will note the no of insertions, re-directions and any complications such as carotid artery puncture. The actual usage time of the US machine will be recorded . |