| CTRI Number |
CTRI/2026/01/102112 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
26/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study comparing Posterior Tibial Arterial Line placement in two different positions (Supine versus Prone) in Adult Surgical Patients |
|
Scientific Title of Study
|
Comparison of Ultrasound-Guided Posterior Tibial Artery Cannulation in Supine Versus Prone Position in Adult Surgical Patients : A Randomised Controlled 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 |
Sudip sikdar |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical care,3rd floor,DnT block,All India Institute of Medical Sciences (AIIMS),HI Area phase 2,Basni Jodhpur
Department of Anaesthesiology and Critical care,3rd floor,DnT block,All India Institute of Medical Sciences (AIIMS),HI Area phase 2,Basni Jodhpur
Jodhpur
RAJASTHAN
342005
India |
| Phone |
8890714129 |
| Fax |
|
| Email |
sudipx.sikdar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyanka Sethi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, All India institute of Medical Sciences (AIIMS), HI Area phase II, Basni
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9352206300 |
| Fax |
|
| Email |
dr.priyanka_sethi@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanka Sethi |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, Jodhpur |
| Address |
Department of Anaesthesiology and Critical Care, 3rd floor, DnT block, All India institute of Medical Sciences (AIIMS), HI Area phase II, Basni
Jodhpur
RAJASTHAN
342005
India
Jodhpur
RAJASTHAN
342005
India |
| Phone |
9352206300 |
| Fax |
|
| Email |
dr.priyanka_sethi@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Jodhpur |
| Address |
All India Institute of Medical Sciences, AICU 3rd floor, Emergency Building DnT block, Jodhpur, Rajasthan, 342005 |
| 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 |
| Dr Sudip Sikdar |
All India Institute of Medical Sciences, Jodhpur |
Department of Anaesthesiology and Critical Care, D and T OT Block, 4th floor,All India Institute of Medical Sciences (AIIMS) Hospital, Basni Phase II , Jodhpur, RAJASTHAN
Jodhpur
RAJASTHAN |
8890714129
sudipx.sikdar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, Jodhpur |
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 |
Ultrasound-guided posterior artery cannulation in supine position |
The intervention is a single-time procedure performed intraoperatively. The duration of the intervention is from ultrasound probe contact with skin to successful arterial catheter placement and securing, with an approximate duration 5-10 minutes per participant. |
| Intervention |
Ultrasound-guided posterior tibial artery cannulation in the prone position |
The intervention is a single-time procedure performed intraoperatively. The duration of the intervention is from ultrasound probe contact with skin to successful arterial catheter placement and securing, with an approximate duration 5-10 minutes per participant. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18–60 years
2. Scheduled for elective surgery requiring prone positioning
3. Requiring intra-arterial blood pressure monitoring
4. Palpable posterior tibial artery preoperatively
5. Written informed consent obtained |
|
| ExclusionCriteria |
| Details |
1. BMI > 30 kg/m²
2. Local infection, cellulitis, or wound near the cannulation site, trauma to the medial
ankle, cannulation in the same artery/site
3. History of peripheral arterial disease
4. Previous surgery
5. PTA could not be visualised or appear thrombosed during initial scan |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Compare the first-attempt success rate of ultrasound-guided PTA cannulation between the
prone and supine positions in adult surgical patients. |
Immediately after the first cannulation attempt |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Anterior posterior arterial diameter of PTA
2. Ultrasonic assessment time (ultrasound probe contact to skin puncture)
3. Cannulation time (Time from needle insertion to successful catheter
placement with backflow)
4. Total procedure time (Includes scanning, puncture, & securing the line)
5. Total Number of attempts for successful cannulation
6. Evaluate complication rates (hematoma, ischemia, arterial spasm, thrombosis)
7. Operator-reported ease/difficulty of cannulation (5-point Likert scale) |
1. Immediately prior to skin puncture
2. During the procedure, at the time of cannulation.
3. During the procedure, at the time of successful cannulation.
4. At the completion of procedure.
5. At the completion of procedure
6. Immediately after the completion of the procedure & before shifting the patient.
7. Immediately after completion of the procedure. |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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 3 |
|
Date of First Enrollment (India)
|
06/02/2026 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 controlled trial aims to compare the effectiveness of ultrasound-guided posterior tibial artery (PTA) cannulation performed in the supine versus prone position in adult surgical patients requiring invasive arterial blood pressure monitoring. Eligible patients will be randomly allocated in a 1:1 ratio to either the supine or prone group using computer-generated block randomization with allocation concealment.
The primary outcome is the first-attempt success rate of PTA cannulation. Secondary outcomes include arterial diameter, ultrasound assessment time, cannulation time, total procedure time, number of attempts, complication rates, and operator-reported ease of cannulation. Outcomes will be assessed during and immediately after the procedure by a blinded outcome assessor.
The findings of this study are expected to help identify the optimal patient positioning for ultrasound-guided PTA cannulation, thereby improving procedural efficiency, safety, and clinical practice in perioperative and critical care settings. |