| CTRI Number |
CTRI/2020/06/025587 [Registered on: 03/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Placement of central venous line in left brachiocephalic vein in pediatric population. |
|
Scientific Title of Study
|
Comparison between in-plane and out-plane techniques for ultrasound guided cannulation of left brachiocephalic vein in pediatric population. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Chandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor, OT Complex, B -Block
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor, OT Complex, B -Block
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandni Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, Patna |
| Address |
Department of anaesthesia,Room no-503,5th floor, OT Complex, B -Block
Patna
BIHAR
801507
India |
| Phone |
7250333148 |
| Fax |
|
| Email |
chandni.doc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, AIIMS, Patna, Phulwarisharif, Bihar, India |
|
|
Primary Sponsor
|
| Name |
AIIMS Patna |
| Address |
Department of Anaesthesia, B-Block, OT complex |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| AIIMS Patna |
Department of Anaesthesia, B-Block, OT complex |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Chandni Sinha |
AIIMS, Patna |
Department of Anaesthesia, B-Block, OT complex
Patna
BIHAR |
7250333148
chandni.doc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS, Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R99||Ill-defined and unknown cause of mortality, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided in-plane cannulation of left brachiocephalic vein in pediatric population. |
We will place the linear USG probe (M‑Turbo, Fujifilm Sonosite, Inc., Bothell, WA, USA) in the left supraclavicular fossa parallel to medial end of clavicle. The probe is tilted caudally to obtain in‑plane view of BCV and venous confluence of three vessels (BCV, IJV and SCV). Doppler power will be used to differentiate subclavian and other arteries from vein. The needle will be inserted in‑plane to probe from lateral to medial direction to puncture left BCV. |
| Comparator Agent |
Ultrasound guided out-plane cannulation of left brachiocephalic vein in pediatric population. |
A linear US probe is applied longitudinally (long axis view) over the inferior portion of the IJV, keeping the caudal end of the transducer overlapping the clavicle. The venous confluence of Pirogoff is visualized. Colour Doppler is used to differentiate venous from arterial structures. The needle is inserted out of plane lateral to the transducer probe and directed medially and caudally to puncture the left BCV. |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
1.00 Year(s) |
| Gender |
Both |
| Details |
ASA I/II
Scheduled for central venous cannulation
|
|
| ExclusionCriteria |
| Details |
Patients with anatomical abnormality at the clavicular region
Local infections at supraclavicular region,
Obese: BMI more than 95 percentile for that age
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First-attempt success rate |
At the time of BCV cannulation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts
Scanning time
Cannulation time/performance time |
At the time of BCV cannulation |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
07/06/2020 |
| Date of Study Completion (India) |
30/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ultrasound guided brachiocephalic vein cannulation becomes very much useful as it fascilitates visualization of entire path of the needle, this reduces complication related to central vein cannulation. The BCV cannulation through supraclavicular route is possible though both in-plane and out-plane approach. This study designed to find out ease of insertion of two technique (in-pane vs out-plane) of BCV cannulation in pediatric population. |