| CTRI Number |
CTRI/2019/02/017824 [Registered on: 26/02/2019] Trial Registered Prospectively |
| Last Modified On: |
16/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing two approaches to pass a cannula in the neck veins under the ultrasound guidance |
|
Scientific Title of Study
|
Comparison of ultrasound guided internal jugular vein cannulation versus supraclavicular approach to brachiocephalic vein cannulation- a prospective randomised clinical study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Keerthi Yogeeswara Gowda |
| Designation |
Post Graduate |
| Affiliation |
SDM medical college and hospital |
| Address |
Department of Anaesthesia,
2nd floor
SDM medical college, Manjushree nagar, Sattur, Dharwad-580009
Dharwad KARNATAKA 580009 India |
| Phone |
08362777755 |
| Fax |
|
| Email |
keerthiyg30@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sameer Desai |
| Designation |
Professor |
| Affiliation |
SDM medical college and hospital |
| Address |
Department of Anaesthesia
2nd floor
SDM medical college, Manjushree nagar, Sattur, Dharwad-580009
Dharwad KARNATAKA 580009 India |
| Phone |
08362777755 |
| Fax |
|
| Email |
sameeranaes@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Keerthi Yogeeswara Gowda |
| Designation |
Post Graduate |
| Affiliation |
SDM medical college and hospital |
| Address |
Department of Anaesthesia
2nd floor
SDM medical college, Manjushree nagar, Sattur, Dharwad-580009
Dharwad KARNATAKA 580009 India |
| Phone |
08362777755 |
| Fax |
|
| Email |
keerthiyg30@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM college of medical sciences and hospital, sattur, Dharwad, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
SDM CMSH |
| Address |
SDM medical college and hospital, manjushree nagar, sattur, dharwad-580009 |
| Type of Sponsor |
Private 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 Keerthi Yogeeswara Gowda |
SDM medical college and hospital |
Department of Anaesthesia, 2nd floor
SDM medical college and hospital, Sattur, Dharwad, Karnataka-580009 Dharwad KARNATAKA |
08362777755
keerthiyg30@gmail.com |
|
|
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: X||New Technology, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided internal jugular vein cannulation group |
USG guided cannulation will be done to internal jugular vein with out of plane approach |
| Comparator Agent |
Ultrasound Guided supraclavicular Brachiocephalic vein cannulation group |
USG guided cannlation will be done to the brachiocepalic vein with USG guidance and approach from supraclavicular area
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients requiring CVC cannulation in Operation Theatre and Intensive Care Units |
|
| ExclusionCriteria |
| Details |
Uncooperative patients/refusal to consent.
Significant coagulopathy INR>1.5/ platelet count<50000.
History of previous surgical intervention at cannulation site.
Presence of CVC during past 72hrs in the same vein in which present cannulation is planned.
Infection/subcutaneous hematoma close to puncture site.
Cervical trauma with neck immobilization.
Emergency surgeries or emergency clinical situation in ICU
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate of central venous cannulation |
At the time of CVC insertion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Cannulation time |
At the time of CVC insertion |
| Preocedural difficulty |
At the time of CVC insertion |
| Complication rate |
time of CVC insertion to 24 hour after procedure |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
Final Enrollment numbers achieved (Total)= "110"
Final Enrollment numbers achieved (India)="110" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
28/02/2019 |
| Date of Study Completion (India) |
29/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
| | Title: Comparison
Of Ultrasound Guided Internal Jugular Vein Cannulation Versus Supraclavicular
Approach To Brachiocephalic Vein Cannulation- A Prospective Single Blind
Randomised Clinical Study Background and objectives:
Cannulation of veins and arteries is an important aspect of patient care for
the administration of fluids, medications and for monitoring purposes. Internal jugular vein (IJV) cannulation is
the most commonly studied site for central vein cannulation in adults.
The Brachiocephalic vein (BCV) has become a
preferred option for central venous cannulation in paediatrics, but its use in
adults remains limited and very few studies compare the BCV to other
cannulation sites. Recently, a retrospective study was done on USG guided BCV cannulation
which suggested that BCV cannulation is a safe and viable alternative to IJV. The objective of this
study is to compare the USG guided out of plane approach to IJV cannulation
with in-plane USG guided supraclavicular approach to BCV cannulation in adults
for the success rate, first attempt success rate, procedural ease and also to
record the incidence of complications related to either approach. Methodology: In this study, the 110 patients
recruited were randomly allocated into two groups of 55 patients each. The
patients demographic details like age, gender, indication for cannulation,
ventilation status and PEEP applied were noted. In group IJV, right internal
jugular vein cannulation was performed using ultrasound guidance out of plane
approach and in group BCV, right brachiocephalic vein cannulation was performed
using ultrasound guidance for supraclavicular in-plane approach. Success rate
of cannulation, number of attempts to cannulate the veins, ease of guidewire
and catheter insertion, cannulation time and any associated complications were
recorded. Result: The demographic details were
similar between the two groups. Successful cannulation was 100% in BCV group
and 98.5% in IJV group, which was statistically insignificant. The first
attempt success rate was 81.81% and 76.3% in BCV and IJV group respectively.
IJV was collapsed in 14.5% cases and BCV was collapsed in 0.9% cases, which was
significant. The needle visualisation was better with BCV group (80% in IJV
group and 94.54% in BCV group), which was statistically significant. The number
of redirections of needle was more in IJV group. The CVC cannulation time and
complication rates were similar between the groups.
Conclusion: Ultrasound guided supraclavicular
in-plane BCV cannulation is a good alternative to USG guided out of plane IJV
cannulation, by having a good calibre and better needle visualisation in the
BCV group. Overall success rate, first attempt success rate, time duration for cannulation
and complication rate remain similar between the two groups. | |