| CTRI Number |
CTRI/2020/09/027757 [Registered on: 11/09/2020] Trial Registered Prospectively |
| Last Modified On: |
15/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
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Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
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Public Title of Study
|
Comparison of Two Methods to Cannulate an Artery using Ultrasound |
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Scientific Title of Study
|
Comparison of Ultrasound Guided Dynamic Needle Tip Positioning Technique and Conventional Long-Axis In-Plane Technique for Radial Arterial Cannulation in Adults Requiring Radial Arterial Cannulation |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAFIYA SHERRIN M K |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR |
| Address |
OASIS, VISWAS KATTACHIRA ROAD, P.O. B P ANGADI, TIRUR, MALAPPURAM, KERALA - 676102, INDIA POST GRADUATE STUDENT, DEPARTMENT OF ANAESTHESIOLOGY, AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR - 680555
KERALA Thrissur KERALA 680555 India |
| Phone |
9496809481 |
| Fax |
|
| Email |
safiyasherrin01@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
DR PAUL O RAPHAEL |
| Designation |
PROFESSOR |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR, CHAVARA BLOCK,
AMALA INSTITUTE OF MEDICAL SCIENCES,
THRISSUR FLAT C2 8123
SOBHA JADE
SOBHA CITY
PUZHAKKAL
670553
THRISSUR
KERALA Thrissur KERALA 680555 India |
| Phone |
8281804916 |
| Fax |
|
| Email |
poloralph1965@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
SAFIYA SHERRIN M K |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR |
| Address |
OASIS, VISWAS KATTACHIRA ROAD, P.O. B P ANGADI, TIRUR, MALAPPURAM, KERALA - 676102, INDIA POST GRADUATE STUDENT, DEPARTMENT OF ANAESTHESIOLOGY, AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR - 680555
KERALA Thrissur KERALA 680555 India |
| Phone |
9496809481 |
| Fax |
|
| Email |
safiyasherrin01@gmail.com |
|
|
Source of Monetary or Material Support
|
| AMALA INSTITUTE OF MEDICAL SCIENCES, THRISSUR |
|
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Primary Sponsor
|
| Name |
AMALA INSTITUTE OF MEDICAL SCIENCES |
| Address |
AMALA INSTITUTE OF MEDICAL SCIENCES, AMALANAGAR, THRISSUR - 680555 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| SAFIYA SHERRIN M K |
AMALA INSTITUTE OF MEDICAL SCIENCES |
DEPARTMENT OF ANAESTHESIOLOGY,FIRST FLOOR, CHAVARA BLOCK, AMALA INSTITUTE OF MEDICAL SCIENCES, AMALANAGAR, THRISSUR - 680555, KERALA Thrissur KERALA |
9496809481
safiyasherrin01@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AMALA INSTITUTE OF MEDICAL SCIENCES INSTITUTIONAL 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: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults from 18 to 90 years of age
2. Adult patients undergoing General Anaesthesia/Regional Anaesthesia who require arterial cannulation |
|
| ExclusionCriteria |
| Details |
patients with
1. age <18 years
2. age >90 years
3. negative modified Allen test
4. history radial artery cannulation in the previous 30 days
5. history of peripheral vascular disease |
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Method of Generating Random Sequence
|
Not Applicable |
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Method of Concealment
|
Not Applicable |
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Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of time to ultrasonographic location of radial artery and its successful cannulation |
5 minutes |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
1. Ultrasonographic measurement of radial artery diameter
2. Ultrasonographic measurement of depth of radial artery from skin |
1 minute |
|
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Target Sample Size
|
Total Sample Size="114" Sample Size from India="114"
Final Enrollment numbers achieved (Total)= "114"
Final Enrollment numbers achieved (India)="114" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2020 |
| Date of Study Completion (India) |
15/10/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not Applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
Comparison of Ultrasound Guided Dynamic Needle Tip Positioning Technique and Conventional Long-Axis In-Plane Technique for Radial Arterial Cannulation in Adults Requiring Radial Arterial Cannulation
INTRODUCTION Arterial cannulation is a common invasive procedure performed in operating theatres and intensive care units. Radial artery is most commonly selected due to its superficial course, double blood supply of the hand and lower risk of complications. Multiple failed attempts at radial arterial cannulation can lead to arterial spasm and patient dissatisfaction. The use of ultrasound increases the success rates of radial arterial cannulation. Conventionally, there are two methods of radial arterial cannulation viz., Short-Axis Out-of-Plane technique and Long-Axis In-Plane technique. The short-axis ultrasound technique has the advantage of better visualization of relevant anatomy, such as abnormal vascular anatomy, nerves, and veins during arterial cannulation. The long-axis technique can provide clear visualization of the position of the needle tip as it approaches and enters the arterial lumen and thus enhance the success rate of threading of a catheter. Dynamic needle tip positioning technique is a new technique combining the two methods. This study was done in order to compare the Dynamic Need Tip Positioning Technique with the conventional Long-Axis In-Plane method.
AIM To compare ultrasound guided dynamic needle tip positioning technique and conventional long- axis in-plane technique for radial arterial cannulation in adults requiring radial arterial cannulation.
OBJECTIVES 1.To assess the success rate among ultrasound guided dynamic needle tip positioning technique in adults adults requiring radial arterial cannulation 2.To assess the success rate among ultrasound guided long-axis, in-plane technique in adults requiring radial arterial cannulation 3.To compare the success rates among these two groups viz. ultrasound guided dynamic needle tip positional technique and ultrasound guided long-axis, in-plane technique in adults requiring radial arterial cannulation
HYPOTHESIS Ultrasound guided dynamic needle tip positioning technique is better than conventional long- axis in-plane technique for radial arterial cannulation in adults requiring radial arterial cannulation
MATERIALS AND METHODS Hospital based observational study for patients from 18 to 90 years from Amala Institute of Medical Sciences, Thrissur to be done on 114 patients with 57 each in both Dynamic Needle Tip Positioning Technique group and Long-Axis In-Plane technique group. Radial arterial cannulation will be performed by a experienced anaesthesiologists with more than 5 years experience in ultrasound guided radial arterial cannulation under strict aseptic precautions.. Instituitional Ethical Committee approval has been obtained and informed written consent will be taken in local language from all patients and relevant data will be collected. Confidentiality of the patients will be maintained. The data obtained will be coded in Microsoft Excel sheet and statistical analysis will be done using SPSS software.
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