| CTRI Number |
CTRI/2026/01/100235 [Registered on: 02/01/2026] Trial Registered Prospectively |
| Last Modified On: |
31/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two ultrasound methods using small linear probe for placing an artery line in adult patients undergoing major surgery |
|
Scientific Title of Study
|
Comparison of Ultrasound guided Short axis and Long axis technique of radial artery cannulation with small linear probe in adult patients undergoing major surgery- A Prospective randomized comparative study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dinkar Laxman Mahale |
| Designation |
Secondary DNB Resident, Department of Anaesthesia |
| Affiliation |
Fortis Hospitals Limited, Mumbai |
| Address |
Department of Anaesthesia,
Fortis Hospitals Limited,
Mulund Goregaon Link Road, Bhandup West, Mumbai
Mumbai
MAHARASHTRA
400078
India |
| Phone |
02241114111 |
| Fax |
|
| Email |
mdinesh8411@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dipti Haridas |
| Designation |
Consultant, Department of Anaesthesia |
| Affiliation |
Fortis Hospitals Limited, Mumbai |
| Address |
Department of Anaesthesia,
Fortis Hospitals Limited,
Mulund Goregaon Link Road, Bhandup West, Mumbai
Mumbai
MAHARASHTRA
400078
India |
| Phone |
70218 25755 |
| Fax |
|
| Email |
diptidhake@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dinkar Laxman Mahale |
| Designation |
Secondary DNB Resident, Department of Anaesthesia |
| Affiliation |
Fortis Hospitals Limited, Mumbai |
| Address |
Department of Anaesthesia,
Fortis Hospitals Limited,
Mulund Goregaon Link Road, Bhandup West, Mumbai
MAHARASHTRA
400078
India |
| Phone |
02241114111 |
| Fax |
|
| Email |
mdinesh8411@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Fortis Hospitals Limited Mumbai |
| Address |
Fortis Hospitals Limited, Mulund Goregaon Link Road, Bhandup West, Mumbai, Maharashtra, India.
Pin code 400078 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Dipti Haridas |
Fortis Hospitals Limited, Mumbai |
Operation theatre,Fortis Hospitals Limited,
Mulund Goregaon Link Road, Bhandup West, Mumbai
Mumbai
MAHARASHTRA |
70218 25755
diptidhake@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided radial artery cannulation – Long axis technique |
Radial artery cannulation performed under ultrasound guidance using long axis approach with a small linear probe in adult patients undergoing elective major surgery.
Total duration of intervention: From skin puncture to successful arterial cannulation or abandonment of attempt, maximum 5 minutes per participant. |
| Intervention |
Ultrasound guided radial artery cannulation – Short axis technique |
Radial artery cannulation performed under ultrasound guidance using short axis approach with a small linear probe in adult patients undergoing elective major surgery.
Total duration of intervention: From skin puncture to successful arterial cannulation or abandonment of attempt, maximum 5 minutes per participant. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult patients aged 18 to 65 years
2.ASA physical status I to III
3.Scheduled for elective major surgeries requiring invasive arterial monitoring.
|
|
| ExclusionCriteria |
| Details |
1 Patients with negative Allen test
2 Peripheral vascular disease of upper limb
3 Coagulation disorders
4 Morbid obesity Body mass index more than 35
5 Refusal to consent
6 atherosclerotic vascular disease
7 previous surgery or deformity in wrist area |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success of radial artery cannulation |
Time point of assessment: Assessed during the procedure, immediately after the first cannulation attempt for each participant. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts required for successful radial artery cannulation |
Time point of assessment: Assessed during the procedure, at completion of cannulation. |
| Cannulation time |
Time point of assessment: Assessed during the procedure, From skin puncture to successful arterial catheter placement. |
| Ease of cannulation |
Time point of assessment: Assessed immediately after successful cannulation. |
| Complications related to radial artery cannulation |
Time point of assessment: Assessed during the procedure & immediately after cannulation. |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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)
|
12/01/2026 |
| 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="9"
Days="0" |
|
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
|
This prospective randomized comparative study aims to compare ultrasound guided short axis and long axis techniques of radial artery cannulation using a small linear probe in adult patients undergoing elective major surgery requiring invasive arterial blood pressure monitoring. Adult patients aged 18 to 65 years with ASA physical status I to III will be randomly allocated into two groups. One group will undergo radial artery cannulation using the ultrasound guided short axis technique and the other group using the long axis technique. The primary outcome will be first attempt success of radial artery cannulation. Secondary outcomes will include number of attempts required for successful cannulation, cannulation time, ease of cannulation, and complications related to radial artery cannulation. The study aims to identify the technique with higher success rate and better procedural efficiency to improve patient safety and procedural outcomes. |