| CTRI Number |
CTRI/2021/08/035731 [Registered on: 17/08/2021] Trial Registered Prospectively |
| Last Modified On: |
13/08/2021 |
| 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 ultrasound guided technique for femoral artery cannulation and waveform assisted ultrsound guided technique in children with heart diseases for surgery |
|
Scientific Title of Study
|
comparison between ultrasound guided technique for femoral artery cannulation and transducer assisted ultrasound guided technique in congenital cardiac surgical patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PRASAD S R |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayadeva institute of cardiovascular sciences and research |
| Address |
Sri Jayadeva institute of cardiovascular sciences,department of
anesthesia, Bannerghatta Main Road, Phase 3, Jayanagara 9th Block,
Bengaluru
Bangalore
KARNATAKA
560069
India |
| Phone |
09886086232 |
| Fax |
|
| Email |
drprasadsr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PRASAD S R |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayadeva institute of cardiovascular sciences and research |
| Address |
Sri Jayadeva institute of cardiovascular sciences,department of
anesthesia, Bannerghatta Main Road, Phase 3, Jayanagara 9th Block,
Bengaluru
KARNATAKA
560069
India |
| Phone |
09886086232 |
| Fax |
|
| Email |
drprasadsr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PRASAD S R |
| Designation |
Associate Professor |
| Affiliation |
Sri Jayadeva institute of cardiovascular sciences and research |
| Address |
Sri Jayadeva institute of cardiovascular sciences,department of
anesthesia, Bannerghatta Main Road, Phase 3, Jayanagara 9th Block,
Bengaluru
KARNATAKA
560069
India |
| Phone |
09886086232 |
| Fax |
|
| Email |
drprasadsr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayadeva Institute of Cardiovascular Sciences and Research |
|
|
Primary Sponsor
|
| Name |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
| Address |
Bannerghatta Main Rd, Phase 3, Jayanagara 9th Block, Jayanagar,
Bengaluru, Karnataka 560069 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prasad S R |
Sri Jayadeva Institute of Cardiovascular Sciences and Research |
first and second floor operation
theater and recovery
room,department of cardiac
anesthesia,SJIC&R,BANGALORE
Bangalore
KARNATAKA
Bangalore
KARNATAKA |
9886086232
drprasadsr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI JAYADEVA INSTITUTE ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q20-Q28||Congenital malformations of the circulatory system, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Transducer assisted ultrasound guided technique for femoral artery
cannulation |
using linear ultrasound probe femoral artery is identified then needle connected to a transducer with continuous
monitoring for the waveform is used to confirm correct position of the needle then guide wire is inserted over which the arterial cannula is threaded |
| Comparator Agent |
ultrasound guided technique for femoral artery cannulation |
a linear ultrasound probe is used to identify the femoral artery then a needle is directed in the direction of the artery ,once a free flow of blood is noted a guide wire is introduced over which the arterial cannula is threaded |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
5.00 Year(s) |
| Gender |
Both |
| Details |
60 patients posted for congenital cardiac surgery of either sex weighing less than 10 kilograms are included |
|
| ExclusionCriteria |
| Details |
.Patients with previous attempts of cannulation at decided arterial cannulation site
• unstable patient in whom an arterial line had to be placed before the randomization will be excluded. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| rate of successful cannulation at first attempt |
0 ,15,30 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total number of attempts,
time taken to cannulate, and
Any complication related to the procedure |
0,6,24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/08/2021 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
in transducer assisted ultrasound technique once the artery is located proper waveform helps to increase the chance of successful guide wire insertion and also helps to differentiate between the artery and vein in cyanotic congenital heart disease in this study we want to compare the first pass success rate time taken to cannulate and the complications with the routine ultrasound guided technique
|