| CTRI Number |
CTRI/2024/07/069722 [Registered on: 01/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the first attempt success rates of ultrasound guided internal jugular vein with ultrasound guided peripheral vein cannulation in patients with difficult intravenous access. |
|
Scientific Title of Study
|
Comparison of Ultrasound guided Peripheral Internal Jugular with Peripheral venous cannulation under Ultrasound guidance in patients with difficult venous access |
| 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 Vijay A |
| Designation |
PG Resident |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, ground floor, main operation theatre building, Safdarjung hospital Campus, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
7904301636 |
| Fax |
|
| Email |
anbumani6105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanya Chugh |
| Designation |
Associate Professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, ground floor, main operation theatre building, Safdarjung hospital Campus, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
9999977026 |
| Fax |
|
| Email |
vanya_chugh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vanya Chugh |
| Designation |
Associate Professor and Consultant |
| Affiliation |
VMMC and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, ground floor, main operation theatre building, Safdarjung hospital Campus, Ansari Nagar East, New Delhi
South
DELHI
110029
India |
| Phone |
9999977026 |
| Fax |
|
| Email |
vanya_chugh@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital,
Department of Anesthesiology and Intensive care,
Ground floor, Main OT complex,
VMMC and Safdarjung hospital campus, Ansari Nagar East,
New Delhi - 110029. |
|
|
Primary Sponsor
|
| Name |
Vardhman Mahavir Medical College and Safdarjung Hospital |
| Address |
Department of Anaesthesia and Intensive care, ground floor, main operation theatre building, Safdarjung hospital Campus, Ansari Nagar East, New Delhi |
| 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 Vanya Chugh |
VMMC AND SAFDARJUNG HOSPITAL |
Department of Anesthesiology and Intensive care,
Floor 1 to 4,
Main OT complex,
Safdarjung hospital Campus, Ansari Nagar East, New Delhi
South
DELHI |
9999977026
vanya_chugh@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: R652||Severe sepsis, (3) ICD-10 Condition: I999||Unspecified disorder of circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Peripheral internal jugular vein cannulation group |
Patient placed in trendelenberg position, ultrasound machine is then prepared with linear transducer probe which is covered with sterile ultrasonic gel. The area is then cleansed with chlorhexidine solution. After 30 seconds the Internal jugular vein is then visualised and 2 percent Lignocaine is used to anaesthetize the surrounding skin. Under ultrasound guidance, an 18G, 2.5 inch Angiocatheter is used to cannulate the patient. Dressing is placed over the catheter to secure in site. The site will be neatly labelled. Chest xray will be done |
| Comparator Agent |
Peripheral vein cannulation group |
In this group, tourniquet is applied proximally over the desired vein in order to get easier access. Ultrasound machine is then prepared with high frequency linear transducer probe which is covered with sterile ultrasonic gel. The area is then cleansed with chlorhexidine solution. After 30 seconds, the desired vein is then visualised and 2 percent Lignocaine is used to anaesthetize the surrounding skin. Under ultrasound guidance, an 18G, 2.5 inch Angiocatheter is used to cannulate the patient. Dressing is placed over the catheter to secure in site. The site will be neatly labelled. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Hemodynamically stable patients
Two or more failed attempts at peripheral IV cannulation
Absence of any visible or palpable veins even after application of tourniquet
|
|
| ExclusionCriteria |
| Details |
Skin infection at the site of insertion
Patients requiring central venous catheter placement at the time of intravenous access |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of first attempt success rate of ultrasound guided peripheral internal jugular with peripheral venous cannulation under ultrasound guidance in patients with difficult venous access. |
To assess the ability to cannulate the vein using ultrasound in the first attempt which is the baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total number of attempts to secure the cannula. |
To find the total number of attempts to secure the cannula
( 1 to 5 ) |
| Time taken to establish venous access |
Duration between application of tourniquet & securing the cannula in position |
| Duration of cannula patency |
To find the duration until which the cannula is patent & it is checked on daily basis ( day 1 to day 14 ) |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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)
|
08/07/2024 |
| 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 - NO
|
|
Brief Summary
|
Difficulty in establishing intravenous access is a common challenge faced by healthcare professionals, particularly in critically ill patients with compromised peripheral veins. Ultrasound guided peripheral IV cannulation is typically used but the success rates were always an issue. To tackle this, ultrasound guided peripheral internal jugular vein cannulation will be performed and the first attempt success rates, total number of attempts to secure the cannula, time taken to establish venous access and duration of cannula patency, Complications , Patient satisfaction and Pain assessment will be measured and compared between those two groups ( peripheral internal jugular vein group and peripheral vein cannulation group). We hypothesize that ultrasound guided peripheral internal jugular vein cannulation is better than peripheral venous cannulation under ultrasound guidance |