| CTRI Number |
CTRI/2018/04/013195 [Registered on: 12/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/06/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two methods of major vein access in sick patients. |
|
Scientific Title of Study
|
supraclavicular v/s infraclavicular approach of subclavian vein cannulation in ICU patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Balwinderjit Singh Walia |
| Designation |
Professor |
| Affiliation |
Punjab institute of medical sciences |
| Address |
Department of Anaesthesia Punjab institute of medical sciences jalandhar
Jalandhar
PUNJAB
144006
India |
| Phone |
9814087951 |
| Fax |
|
| Email |
drbalwinder2000@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ASHA Anand |
| Designation |
Assistant Professor |
| Affiliation |
Punjab institute of medical sciences |
| Address |
Department of Anaesthesia,Panjab institute of medical sciences Jalandhar Punjab
Jalandhar
PUNJAB
144006
India |
| Phone |
7973449563 |
| Fax |
|
| Email |
docsaasha2009@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr iqbal singh |
| Designation |
Professor and head |
| Affiliation |
Punjab institute of medical sciences |
| Address |
Department of Anaesthesia Punjab institute of medical sciences jalandhar
Jalandhar
PUNJAB
144006
India |
| Phone |
9888031025 |
| Fax |
|
| Email |
iqbal_singh1950@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia Panjab institute of medical sciences Jalandhar |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Punjab Institute of Medical Sciences, Garha Road, Jalandhar |
| 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 Balwinderjit walia |
intensive care unit complex |
First floor ,punjab institute of medical sciences
Jalandhar
PUNJAB |
0181-6606000
anaesthesia@pimsj.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PIMS ethical commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
60 Patients of either sex admitted in ICU requiring Subclavian Vein Cannulation, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
infraclavicular approach |
Infraclavicular approach of subclavian vein cannulation in ICU patients. |
| Intervention |
Supraclavicular approach |
Supraclavicular approach of subclavian vein cannulation in ICU patients |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
60 adult patients of either sex admitted in ICU requiring central venous cannulation |
|
| ExclusionCriteria |
| Details |
Patients with infection at puncture site, deranged coagulation profile, contralateral pneumothorax, distorted anatomy of neck, cervical spine trauma |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Total access time of cannulation of each technique and
Total access time of cannulation of each technique and
first attempt success rate of each technique. |
Single point of time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of complications |
Single |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/09/2015 |
| Date of Study Completion (India) |
15/03/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
TITLE: Supraclavicular versus Infraclavicular approach of subclavian vein cannulation in ICU patients Background: Subclavian vein is generally preferred in ICU for central access. Infraclavicular and supraclavicular approaches are the two techniques of subclavian venous catheterisation. Infra clavicular approach to subclavian vein has been widely used. The supraclavicular approach is less often used though this approach of subclavian vein catheterisation has some distinct advantages. So aim of our study was to compare the supraclavicular and infraclavicular approaches of subclavian vein cannulation in terms of success rate and safety profile. Material and Methods: A total of sixty critically ill patients aged between twenty-sixty years of either sex admitted in ICU, where central venous catheterisation was indicated were enrolled in the study. Group I included thirty patients where right Subclavian vein cannulation was performed using Supraclavicular approach. Group II included thirty patients where right Subclavian vein cannulation was performed using Infraclavicular approach.The parameters recorded in the study included success rate of cannulation, number of attempts to cannulate the vein, time required to obtain the access and the various complications. The results of the study were compiled, tabulated and compared statistically using unpaired t-test and Pearson’s Chi-square test. Results:The first attempt success rate in Group I (supraclavicular group) is significantally higher than in Group II (Infraclavicular group).The time required to access is also less in GroupI( supraclavicular group) as compared to Group II and is statistically significant. Conclusion: We concluded that supraclavicular approach has high first attempt success rate and also the time required to access is less as compared to infraclavicular approach. Keywords: ICU, subclavian vein, supraclavicular approach, infraclavicular approach |