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CTRI Number  CTRI/2025/01/079191 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 21/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Internal Jugular Venous Cannulation Using Jugular Venous Pulsation Versus Ultrasound In Patients Undergoing Major Elective Surgery  
Scientific Title of Study   Jugular Venous Pulsation Approach Versus Ultrasound Guided Approach For Internal Jugular Venous Cannulation In Major Elective Surgery: A Randomized, Non inferiority 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  Dr Deepak Nehra  
Designation  Junior Resident  
Affiliation  Aiims Rishikesh  
Address  Department Of Anaesthesiology Aiims Rishikesh Virbhadra Road Rishikesh Dehradun Uttarakhand 249203 India

Dehradun
UTTARANCHAL
249203
India 
Phone  9950106515  
Fax    
Email  dknehra98@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ajay Kumar 
Designation  Additional Professor  
Affiliation  Aiims Rishikesh  
Address  Department Of Anaesthesiology Aiims Rishikesh Virbhadra Road Rishikesh Dehradun Uttarakhand 249203 India

Dehradun
UTTARANCHAL
249203
India 
Phone  9340482058  
Fax    
Email  ajaymishra0701@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Ajay Kumar  
Designation  Additional Professor  
Affiliation  Aiims Rishikesh  
Address  Department Of Anaesthesiology Aiims Rishikesh Virbhadra Road Rishikesh Dehradun Uttarakhand 249203 India

Dehradun
UTTARANCHAL
249203
India 
Phone  9340482058  
Fax    
Email  ajaymishra0701@gmail.com  
 
Source of Monetary or Material Support  
Department Of Anaesthesiology Aiims Rishikesh Virbhadra Road Rishikesh Dehradun Uttarakhand 249203 India 
 
Primary Sponsor  
Name  Department Of Anaesthesiology Aiims Rishikesh 
Address  Department Of Anaesthesiology Aiims Rishikesh Virbhadra Road Rishikesh Dehradun Uttarakhand 249203 India  
Type of Sponsor  Other [NA] 
 
Details of Secondary Sponsor  
Name  Address 
None   NA 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Deepak Nehra   All India Institute of Medical Sciences Rishikesh   Department Of Anaesthesiology Aiims Rishikesh Virbhadra Road Rishikesh Dehradun Uttarakhand 249203 India
Dehradun
UTTARANCHAL 		 9950106515

dknehra98@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I279||Pulmonary heart disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Jugular Venous Pulsation group  Anatomical landmarks such as medial head of sternocleidomastoid muscle, sternal notch, cricoid cartilage, and clavicle are identified. A double pulsation of JVP is elicited in and around anatomical triangle and marked at two adjacent or nearby points which disappears with inspiration. A line is drawn joining two points of pulsation of JVP and extended further towards cranium on the neck up to 2/3rd of neck parallel to apex of sedilot’s triangle. The point of entry of CVC cannula will be on the line drawn with needle directed towards ipsilateral nipple. For precaution, identified site of prick will be palpated to rule out underlying carotid at the point of entry.  
Intervention  Ultrasound group   Under strict asepsis using USG linear probe (Philips CX50 ultrasound 13 S linear probe) draped in a sterile plastic sheath. Real-time short-axis view and out-of-plane approach will be used for percutaneous puncture by introducer needle followed by guidewire placement. Transthoracic US probe will also confirm the placement of guidewire in subcostal bicaval view coming through SVC into right atrium. It will be performed by a third person trained in basic transthoracic echocardiography. A triple lumen central venous catheter will be threaded over the guidewire after dilatation of the percutaneous tract using the Seldinger technique. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  American Society Of Anaesthesiologists Grade I-III Patients In Which jugular venous pulsation is visible in supine position in at least lower 1/3 of neck undergoing Major Elective Surgery (cardiac and non - cardiac)

 
 
ExclusionCriteria 
Details  Emergency and sick patients-American Society of Anaesthesiologists grade IV, Intubated patients.
Patients not having visible jugular venous pulsation.
Skin or soft tissue infection at site of cannulation.
Coagulopathies (International normalized ratio more than 1.5, Platelet count less than 50,000).
Pathologies like superior vena cava syndrome, head, and neck tumour.
Non patency of internal jugular vein, thrombosis of jugular vein .
Patients with Body Mass index less than 18.5 kg /square metre.
Patients with bounding carotid pulse such as aortic regurgitation.

 
 
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 
Comparison of overall success rate of internal jugular vein cannulation between landmark approach using jugular venous pulsation and ultrasound guided approach.   Internal jugular vein cannulation will be considered overall successful if it is achieved within three attempts. 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of first attempt success rate between landmark approach using jugular venous pulsation and ultrasound guided approach  Internal jugular vein cannulation will be considered successful at first attempt if it is achieved with first needle pass with or without forward and withdrawal movement on the same site. 
Comparison of incidence of arterial puncture between landmark approach using Jugular venous pulsation and ultrasound guided approach.  Carotid artery puncture will be defined as unintentional placement of needle or catheter into neck vessels that yielded bright red or pulsatile blood. 
Comparison of time taken for successful cannulation between landmark approach using jugular venous pulsation and ultrasound guided approach.  Time for successful cannulation is defined as time taken from ultrasound probe held on neck till successful cannulation of guidewire by Seldinger technique and confirmation of wire by transthoracic USG in subcostal view. In case of JVP guided central venous cannulation it is defined as time taken from identification of puncture site by JVP, till confirmation of wire by transthoracic USG in subcostal bicaval view. 
Comparison of hematoma between landmark approach using jugular venous pulsation and ultrasound guided approach.  Hematoma formation will be defined as formation of visible neck swelling at the site of cannulation (attempted cannulation). 
Comparison of number of attempts in overall success rate between landmark approach using jugular venous pulsation and ultrasound guided approach.  An Attempt is defined as passage of CVC needle at puncture site without any redirection and without withdrawing needle out of skin. A new site puncture of skin or redirection at the same site will be considered another attempt. 
 
Target Sample Size   Total Sample Size="62"
Sample Size from India="62" 
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 1/ Phase 2 
Date of First Enrollment (India)   01/02/2025 
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="0"
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   Real time ultrasound (US) guided IJV cannulation is the standard of care and has been recommended to reduce complication . However landmark approach for securing IJV cannulation is still practiced routinely for skill acquisition, training, low resource settings and unavailability of ultrasound machine.  It can be presumed that IJV cannulation by jugular venous pulsation approach is as safe as US guided approach as some studies have shown jugular venous pulsation approach as a promising landmark. It needs to be explored in an objective way so that it can be replicated on a large population.  AIM OF THE STUDY is that Success rate of central venous cannulation by landmark approach using jugular venous pulsation is as effective as ultrasound guided approach.

 
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