FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/06/053718 [Registered on: 09/06/2023] Trial Registered Prospectively
Last Modified On: 07/06/2023
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 ulnar and radial artery cannulation with help of ultrasonography in obese and non-obese patients undergoing surgery under anesthesia 
Scientific Title of Study   Comparison of ulnar and radial artery cannulation under ultrasound guidance in obese and non-obese groups- a randomised study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Sonal Saini 
Designation  Junior Resident (Academic) 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, 4th floor, Room no. 409, Academic building, AIIMS Bhubaneswar, Sijua, Patrapada, PO-Dumuduma, Bhubaneswar, Orissa-751019

Khordha
ORISSA
751019
India 
Phone  7014242356  
Fax    
Email  sonalsainim17@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Suma Rabab Ahmad 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, 4th floor, Room no. 409, Academic building, AIIMS Bhubaneswar, Sijua, Patrapada, PO-Dumuduma, Bhubaneswar, Orissa-751019

Khordha
ORISSA
751019
India 
Phone  7259000696  
Fax    
Email  suma.ahmad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Suma Rabab Ahmad 
Designation  Associate Professor 
Affiliation  AIIMS Bhubaneswar 
Address  Department of Anaesthesiology and Critical Care, 4th floor, Room no. 409, Academic building, AIIMS Bhubaneswar, Sijua, Patrapada, PO-Dumuduma, Bhubaneswar, Orissa-751019

Khordha
ORISSA
751019
India 
Phone  7259000696  
Fax    
Email  suma.ahmad@gmail.com  
 
Source of Monetary or Material Support  
AIIMS Bhubaneswar 
 
Primary Sponsor  
Name  AIIMS Bhubaneswar 
Address  AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumuduma, Bhubaneswar, Orissa-751019 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sonal Saini  AIIMS Bhubaneswar  Department of Anesthesiology and Critical care, Academic building, 4th floor, room 409
Khordha
ORISSA 		 7014242356

sonalsainim17@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, All India Institute of Medical Sciences, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  ultrasound guided radial artery cannulation  radial artery will be cannulated under ultrasound guidance in obese and non-obese groups 
Intervention  ultrasound guided ulnar artery cannulation  ulnar artery will be cannulated under ultrasound guidance in obese and non-obese groups  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. ASA 1 and ASA 2 patients
2. age 18 to 65 year
3. positive modified Allen and inverse Allen test
4. undergoing elective surgery under anaesthesia (general or regional) and requiring arterial cannulation  
 
ExclusionCriteria 
Details  Following patients will be excluded:
1. patients not giving consent
2. patients having coagulopathy
3. presence of local anatomic distortion (traumatic or congenital)
4. presence of local site infection/cellulitis
5. history of prior surgery in the area
6. history of arterial cannulation in the area in last 14 days
7. patients with vascular disease













 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the first attempt success rate of radial and ulnar artery cannulation under ultrasound guidance in obese and non-obese groups  At the time 0f arterial cannulation 
 
Secondary Outcome  
Outcome  TimePoints 
1. ease of insertion of cannula-easy (1 attempt), difficult (2-3 attempts), failure (more than 3 attempts)
2. Cross-sectional area, maximum internal diameter and depth from skin surface- in short and in long axis view
3. Doppler peak systolic flow before cannulation and after 1 hour of removal of cannula
4. complications of arterial cannulation up till 5 days of insertion 		 At the time of cannulation, after 1 hour of cannulation, up to 5 days after cannula insertion 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   03/07/2023 
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="7"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Invasive blood pressure monitoring is commonly done. Radial artery is commonly cannulated. With the advent of USG deeper arteries like ulnar artery can even be cannulated. In obese patients artery cannulation is proposed to be difficult but we expect it to be done with more ease under USG guidance. Comparison of first attempt success rate of ulnar versus radial arterial cannulation under USG guidance in obese and non-obese groups of patients has not yet been studied. 
Close