| CTRI Number |
CTRI/2021/07/034529 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
02/07/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between direct feel method for radial artery cannulation and waveform visualization method in adult cardiac surgical patients |
|
Scientific Title of Study
|
Comparison between digital palpation technique for radial artery cannulation and transducer technique in adult 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 |
| Address |
Sri Jayadeva institute of cardiovascular sciences,department of anesthesia,
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Jayanagar, Bengaluru,
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Jayanagar, Bengaluru, Karnataka 560069
Bangalore
KARNATAKA
560069
India |
| Phone |
9886086232 |
| 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 |
| Address |
Sri Jayadeva institute of cardiovascular sciences,department of anesthesia,
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Jayanagar, Bengaluru,
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Jayanagar, Bengaluru, Karnataka 560069
Bangalore
KARNATAKA
560069
India |
| Phone |
9886086232 |
| 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 |
| Address |
Sri Jayadeva institute of cardiovascular sciences,department of anesthesia,
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Jayanagar, Bengaluru,
Bannerghatta Main Road, Phase 3, Jayanagara 9th Block, Jayanagar, Bengaluru, Karnataka 560069
Bangalore
KARNATAKA
560069
India |
| Phone |
9886086232 |
| Fax |
|
| Email |
drprasadsr@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Jayadeva institute of cardiovascular sciences |
|
|
Primary Sponsor
|
| Name |
Sri Jayadeva Institute of Cardiovascular Sciences and Researc |
| 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 |
Department of anesthesia,1st and 2nd floor operation theater,
Sri Jayadeva Institute of Cardiovascular Sciences and Research
Jayanagar 9th Block,
Bannerghatta Road
Bangalore - 560 069
Karnataka, India
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: I251||Atherosclerotic heart disease of native coronary artery, (2) ICD-10 Condition: I083||Combined rheumatic disorders of mitral, aortic and tricuspid valves, (3) ICD-10 Condition: O||Medical and Surgical, (4) ICD-10 Condition: I52||Other heart disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
blind palpatory technique |
After palpating the artery cannula is inserted once backflow in the flash chamber is seen ,cannula is threaded into the artey blindly assuming that the cannula to be inside the artery |
| Intervention |
Transducer technique for radial artery cannulation |
A 20g cannula connected to a transducer with continuous monitoring for the arterial pressure waveform is used to guide the cannula into the artery, which provides definitive evidence of cannula inside the artery, once cannulation is done the procedure is completed but the patient will be observed for 24 hours for any complications |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
hundred patients posted for cardiac surgery of either sex aged between 18 to 60 years |
|
| ExclusionCriteria |
| Details |
• Patients with previous attempts at arterial cannulation during the same
• unstable patient in whom an arterial line had to be placed before the study, randomization will be excluded.
• Patients with peripheral vascular disease
• Patients with subclavian artery stenosis
• Abnormal Allen’s test
|
|
|
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 of radial artery |
first attempt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total number of attempts,
• The time taken to cannulate, and
• Any complication related to the procedure
|
0,6,24 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
10/07/2021 |
| 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
|
PROSPECTIVE RANDOMISED CONTROL TRIAL. Compare the novel transducer technique which provides more objective evidence in threading the cannula during arterial cannulation and reduces its complications |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Transducer technique is a novel method for cannulation of the artery for blood pressure monitoring and sampling of blood for arterial blood gas analysis, in this study we want to compare the first pass success rate, time taken to cannulate, and complications in this novel method as compared to the traditional palpatory method of radial artery cannulation |