| CTRI Number |
CTRI/2024/04/065155 [Registered on: 03/04/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two different techniques of central line insertion in ICU Patients in terms of time, success and complications. |
|
Scientific Title of Study
|
Comparison of pen holding technique with conventional needle holding technique for ultrasound guided internal jugular venous cannulation in ICU patients. |
| 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 Tarun Yadav |
| Designation |
Associate Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak |
| Address |
Department of Anaesthesiology,
Room no 25,
Second Floor,
New OT cum ICU Complex,
PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8826444011 |
| Fax |
|
| Email |
drtarunyadav@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tarun Yadav |
| Designation |
Associate Professor |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak |
| Address |
Department of Anaesthesiology,
Room no 25,
Second Floor,
New OT cum ICU Complex,
PGIMS, Rohtak, Haryana
Rohtak
HARYANA
124001
India |
| Phone |
8826444011 |
| Fax |
|
| Email |
drtarunyadav@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Twinkle Bhagat |
| Designation |
PG Student |
| Affiliation |
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
Room no 25, Second Floor, Department of Anaesthesiology,
New OT Complex, PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9306040947 |
| Fax |
|
| Email |
twinklebhagat26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt. of Haryana,
Director, Director Office, Pandit Bhagwant Dayal Sharma Post Graduate Institute of Medical Science Rohtak, Haryana, India
Pincode-124001
|
|
|
Primary Sponsor
|
| Name |
Government of Haryana _ Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences |
| Address |
PGIMS Campus, Rohtak, Haryana, India Pincode - 124001
|
| Type of Sponsor |
Government medical college |
|
|
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 Tarun Yadav |
Pt BDS PGIMS |
Room no 25, Second Floor, Department of Anaesthesiology,Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak
Rohtak
HARYANA |
8826444011
drtarunyadav@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee Pt. B.D. Sharma PGIMS/UHS, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional needle holding technique |
Internal Jugular Vein will be cannulated using conventional needle holding technique
Duration - time from skin puncture to placement of guidewire in IJV |
| Intervention |
Pen holding technique
|
Internal Jugular Vein will be cannulated using proximal pen holding technique.
Duration - time from skin puncture to placement of guidewire in IJV |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients aged between 18-60 years, of either sex requiring central venous cannulation admitted in intensive care unit. |
|
| ExclusionCriteria |
| Details |
Patients with Bleeding tendency, Cervical spine disorders, Neck surgery/pathology, Burns patients, Patients on high doses of inotropes/vasopressors, Pregnant females and patients unwilling to participate will be excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare time taken for successful guidewire insertion. |
T1 - At successful placement of guidewire in IJV |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare number of attempts to localize the vein.
|
T1 - At successful placement of guidewire in IJV |
| To compare ease of procedure. |
T2 - At successful placement of CVP catheter in IJV |
| To compare incidence of posterior vessel wall puncture |
T1 - At successful placement of guidewire in IJV |
| To compare incidence of any other complications |
T2 - At successful placement of CVP catheter in IJV |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/04/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Title :Comparison of pen holding technique with conventional needle holding technique for ultrasound guided internal jugular venous cannulation in ICU patients. Aim :To compare proximal pen-holding technique with conventional technique to cannulate right internal jugular vein under ultrasound guidance.
Primary Objective: 1. To compare time taken for successful guidewire insertion
Secondary objectives:
1. To compare number of attempts to localize the vein.
2. To compare ease of procedure.
3. To compare incidence of posterior vessel wall puncture. 4. To compare incidence of any other complications.
Inclusion criteria: Adult patients aged between 18-60 years, of either sex requiring central venous cannulation admitted in intensive care unit.
Exclusion criteria:
Patients with Bleeding tendency, Cervical spine disorders, Neck surgery/pathology, Burns patients.
Patients on high doses of inotropes/vasopressors, Pregnant females and Unwilling to participate
will be excluded.
Sample Size: 132 (66 in each arm)
Group allocation
Patients will be allocated into one of the following groups using computer generated randomization table.
Group P (n=66) will be cannulated with proximal pen holding technique.
Group C (n=66) will be cannulated with conventional needle holding technique.
Assessment :
1)Time taken for successful guidewire placement in seconds, Number of attempts required to localize the vein,Number of redirections in each attempt, Ease of the procedure, Incidence of PVWP, Any other complications ,Adverse events and Failure
Analysis :
Data will be compiled, compared and appropriate statistical test will be applied to analyse the results. |