| CTRI Number |
CTRI/2021/05/033859 [Registered on: 28/05/2021] Trial Registered Prospectively |
| Last Modified On: |
27/05/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective observational study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ultrasound guided placement of catheter in the blood vessels of patient with different types leaking and narrow valves of the heart |
|
Scientific Title of Study
|
Ultrasound guided radial arterial cannulation in patient with regurgitant and stenotic left sided cardiaclesions. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rakhi Krishna C M |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research, Pondicherry |
| Address |
Department of Anaesthesiology and Critical care, Old hospital Building, JIPMER, Dhanvantari Nagar, Puducherry 605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9497304497 |
| Fax |
|
| Email |
rkchalora01@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Kumar Mishra |
| Designation |
Additional Professor |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research, Pondicherry |
| Address |
Department of Anaesthesiology and Critical care, Old hospital Building, JIPMER, Dhanvantari Nagar, Puducherry 605006
India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9344668104 |
| Fax |
|
| Email |
jipmermishra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rakhi Krishna C M |
| Designation |
Junior resident |
| Affiliation |
Jawaharlal institute of postgraduate medical education and research, Pondicherry |
| Address |
Department of Anaesthesiology and Critical care, Old hospital Building, JIPMER, Dhanvantari Nagar, Puducherry 605006, India
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9497304497 |
| Fax |
|
| Email |
rkchalora01@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal institute of postgraduate medical education and research,
Dhanvantari Nagar, Puduchherry 605006, India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and Research |
| Address |
Jawaharlal institute of postgraduate medical education and research,
Dhanvantari Nagar, Puduchherry 605006, India |
| Type of Sponsor |
Research institution and hospital |
|
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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 RAKHI KRISHNA C M |
Jawaharlal institute of postgraduate medical education and research |
Anaesthesiology office
2nd floor, hospital block
department of Anaesthesiology and critical care
Jawaharlal institute of postgraduate medical education and research,
Dhanvantari Nagar, Puduchherry 605006, India
Pondicherry
PONDICHERRY |
9497304497
rkchalora01@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER institutional ethics committee. |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All patients with underlying severe stenotic and regurgitant cardiac valvular lesions undergoing cardiac and non cardiac surgery. |
|
| ExclusionCriteria |
| Details |
1)Patients with severe mixed stenotic and regurgitatnt valvular lesions.
2)Patients with preoperative Intra Aortic Balloon Counter pulsation and prosthetic valve dysfunction.
3)Patients requiring preoperative inotropic agents. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the first attempt success rate of ultrasound guided radial artery cannulation in left sided regurgitant cardiac valvular lesions with left sided stenotic valvular lesions. |
During intervention (placement of arterial catheter)
5 minutes after catheter placement
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To compare failure rate, number of attempts, number of redirections, time taken for ultrasound guided radial artery cannulation in left sided regurgitant cardiac valvular lesion with left sided stenotic cardiac valvular lesions.
2)To compare the incidence and extent of peri arterial hematoma formation in ultrasound guided radial artery cannulation in left sided regurgitant cardiac valvular lesion with left sided stenotic cardiac valvular lesions.
|
During catheter placements
5 minutes after placement of catheter
|
|
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Target Sample Size
|
Total Sample Size="152"
Sample Size from India="152"
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)
|
10/06/2021 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study comparing ultrasound guided radial arterial cannulation in patient with regurgitant and stenotic left sided cardiac lesions. Group -1 will be patient with underlying stenotic left sided cardiac valvular lesion undergoing cardiac and non cardiac surgery. Group -2 will be patient with underlying regurgitant left sided cardiac valvular lesion undergoing cardiac and non cardiac surgery. Primary outcome measures will be first attempt success rate of ultrasound guided radial artery cannulation in each group. secondary outcomes include a)to compare failure rate, number of attempts, number of redirections, time taken for ultrasound guided radial artery cannulation in each group. b) to compare the incidence and extent of peri arterial hematoma formation in ultrasound guided radial artery cannulation in each group.
Arterial cannulation is a common and important procedure performed to allow continuous blood pressure monitoring and repeated arterial blood sampling. The most common site for arterial cannulation is the radial artery, because of the relatively low rate of complications, dual arterial supply to the hand and its superficial location. Pulse characteristics may vary with the type of cardiac valvular lesions which may pose challenges during arterial cannulation. Characteristics of pulse varies due to the changes in stroke volume in different left sided cardiac valvular lesions. therefore this study seeks to identify the difference in cannulation success in different types of left sided valvular lesion.
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