| CTRI Number |
CTRI/2024/05/067282 [Registered on: 14/05/2024] Trial Registered Prospectively |
| Last Modified On: |
13/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficacy of Ultrasound Guided and Palpation Technique for Arterial Line Placement in patient posted in our hospital
|
|
Scientific Title of Study
|
Comparison of Ultrasound Guided Versus Digital Palpation Technique for radial Artery cannulation in patient undergoing elective surgeries: A Randomized Control Trial.
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Durgapriya |
| Designation |
PG student |
| Affiliation |
Sri manakula vinayagar medical College and hospital |
| Address |
Division:1
No 49, iyannar Kovil st, Kodambakkam, Puducherry
Kalitheerthalkuppam madagadipet
Pondicherry - 605107
Pondicherry
PONDICHERRY
605110
India |
| Phone |
9092452198 |
| Fax |
|
| Email |
durgag1105@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suneeth P Lazarus |
| Designation |
HOD and Professor |
| Affiliation |
Sri manakula vinayagar medical College and hospital |
| Address |
Division:1
Department of Anesthesiology, first floor, hospital block,
Kalitheerthalkuppam,madagadipet
Kalitheerthalkuppam madagadipet
Pondicherry - 605107
Pondicherry
PONDICHERRY
605110
India |
| Phone |
9894332543 |
| Fax |
|
| Email |
lazarus.suneeth@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Durgapriya |
| Designation |
Post graduation student |
| Affiliation |
Sri manakula vinayagar medical College and hospital |
| Address |
Division:2
Department of Anesthesiology
First floor, hospital block
Kalitheerthalkuppam
Kalitheerthalkuppam madagadipet
Pondicherry - 605107
Pondicherry
PONDICHERRY
605110
India |
| Phone |
9092452198 |
| Fax |
|
| Email |
durgag1105@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula vinayagar medical College and hospital, kalitheerthalkuppam madagadipet,India, Pondicherry 605107 |
|
|
Primary Sponsor
|
| Name |
Durgapriya |
| Address |
Kalitheerthalkuppam madagadipet Pondicherry 606107 |
| Type of Sponsor |
Private medical college |
|
|
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 Durgapriya G |
Sri Manakula vinayagar medical College and hospital |
SMVMCH, Kalitheerthalkuppam, Puducherry 605107
Pondicherry
PONDICHERRY |
9092452198
durgag1105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Palpation method arterial cannulation |
Arterial line insertion using palpation method |
| Intervention |
USG guided arterial cannulation |
Insertion of arterial line under ultrasound guidance
For 18 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist (ASA) II-IV patients
Patients undergoing major Surgeries and patients requiring frequent ABG sampling. |
|
| ExclusionCriteria |
| Details |
Pregnancy
Patient who had negative modified Allen’s test
Patient with peripheral vascular disease
Patient with coagulopathies and bleeding disorders. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success or failure 10mins |
At the end of complete cannulation 15mims |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts |
At the end of complete cannulation |
| Time taken for cannulation |
At the end of complete cannulation |
| Complications due to cannulation |
24 hours after cannulation |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/05/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Participants will be randomly allocated into 2 groups: Group A (USG guided radial artery cannulation) and Group B (Digital palpation technique for radial arterial cannulation). On the day of surgery patients will be shifted into the operation theatre large bore I.V line access will be secured and Standard ASA monitors will be attached with non-invasive blood pressure (NIBP), electrocardiogram (ECG), heart rate, pulse oximetry. Hemodynamic parameters will be recorded. Anaesthesia protocol was standardized for drugs used in this procedure. Modified Allen’s test will be performed in the non dominant hand of the patient. Patients will be taken up to post-operative ward and will be observed for 24 hours in view of any complications related to the procedure (hematoma; infections; thrombosis; ischemia and complex pain syndrome)
|