| CTRI Number |
CTRI/2023/09/058169 [Registered on: 29/09/2023] Trial Registered Prospectively |
| Last Modified On: |
30/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A comparative study of two types of central venous cannulations, subclavian vein and brachiocephalic vein in adult neurosurgical patients |
|
Scientific Title of Study
|
Success rate of ultrasound-guided right infraclavicular subclavian vein versus supraclavicular brachiocephalic vein cannulation in adult neurosurgical patients-An observational study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shijas m |
| Designation |
Junior resident |
| Affiliation |
Government medical college kozhikode |
| Address |
Department of Anaesthesiology
government medical college kozhikode
medical college junction,mavoor road
Kozhikode
KERALA
673008
India |
| Phone |
9562972414 |
| Fax |
|
| Email |
shijas5630@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Biji KP |
| Designation |
Professor (CAP) |
| Affiliation |
Government medical college kozhikode |
| Address |
Department of Anaesthesiology
government medical college kozhikode
medical college junction,mavoor road
Kozhikode
KERALA
673008
India |
| Phone |
9895131600 |
| Fax |
|
| Email |
drbijikp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shijas m |
| Designation |
Junior resident |
| Affiliation |
Government medical college kozhikode |
| Address |
Department of Anaesthesiology
government medical college kozhikode
medical college junction,mavoor road
KERALA
673008
India |
| Phone |
9562972414 |
| Fax |
|
| Email |
shijas5630@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goverment medical college kozhikode,medical college junction,mavoor road,kozhikode,kerala-673008 |
|
|
Primary Sponsor
|
| Name |
Shijas m |
| Address |
Junior resident
department of anaesthesiology
government medical college kozhikode,kerala 673008 |
| Type of Sponsor |
Other [Principal investigator] |
|
|
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 Shijas m |
Government medical college hospital kozhikode |
Department of Anaesthesiology/Major operation theatre complex/Neurosurgery operation theatre
Kozhikode
KERALA |
9562972414
shijas5630@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee government medical college kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients posted for elective neurosurgical procedures,requiring central venous cannulation
2.Patients with American society of anasethesiologists physical status I and II
3.Height between 150-170 cm |
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Coagulopathy
3.Infection at cannulation site
4.Patients with central venous catheter insitu/history of right sided central venous catheter in the past
5.Patients with vervical trauma with neck immobilisation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
First attempt success rate
Overall success rate |
1.5 Years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Overall success rate
2.Procedural ease
3.Difficulty in guide wire passage
4.Total Central venous cannulation time
5.Major complications |
1.5 years |
|
|
Target Sample Size
|
Total Sample Size="84"
Sample Size from India="84"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2023 |
| Date of Study Completion (India) |
21/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [shijas5630@gmail.com].
- For how long will this data be available start date provided 02-04-2025 and end date provided 04-03-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
After obtaining Institutional Research Committee and Ethical Committee approval, 84 patients will be selected based on inclusion and exclusion criteria. Informed written consent shall be obtained from the patient and a primary care giver of the patient.Eighty four patients who are willing to be a part of the study will be allocated to two groups of 42 patients each- Group SCV and Group BCV using convenient sampling.Procedure will be performed by a consultant anaesthesiologist having a 5 year of experience after induction and intubation. A portable Mindray USG scanner (2D) mode with a linear transducer probe of 5-12 MHz will be used. Under aseptic precautions, preparation and draping of the cannulation site will be done.Under usg guidence right infraclaviculae subclavian vein and supraclavicular brachiocephalic vein will be cannulated.Now the trial is ongoing. We started recruiting the subjects to both the groups based on the inclusion and exclusion criterias.
|