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CTRI Number  CTRI/2022/09/045231 [Registered on: 05/09/2022] Trial Registered Prospectively
Last Modified On: 04/09/2022
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   Comparison of two different approaches to subclavian vein puncture with ultrasound guidance 
Scientific Title of Study   Comparison Of In-Plane Approach with Anterior Out-Of-Plane Approach in Ultrasound Guided Supraclavicular Subclavian Vein Cannulation: A Randomized Control Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr O N Nikkila Mai 
Designation  Junior Resident 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dept of Anaesthesiology and Critical Care Office, Second floor, Institute block,, Gorimedu, Pondicherry, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9100099724  
Fax    
Email  nikkinivas@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohan V K 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dept of Anaesthesiology and Critical Care Office, Second floor, Institute block,, Gorimedu, Pondicherry, 605006

Pondicherry
PONDICHERRY
605006
India 
Phone  9841546265  
Fax    
Email  drmohanvk@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Mohan V K 
Designation  Additional Professor 
Affiliation  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  Dept of Anaesthesiology and Critical Care Office, Second floor, Institute block,, Gorimedu, Pondicherry, 605006


PONDICHERRY
605006
India 
Phone  9841546265  
Fax    
Email  drmohanvk@gmail.com  
 
Source of Monetary or Material Support  
Jawaharlal Institute of Postgraduate Medical Education and Research 
 
Primary Sponsor  
Name  Jawaharlal Institute of Postgraduate Medical Education and Research 
Address  JIPMER Campus road, Gorimedu, Dhanvantari Nagar, Pondicherry, 605006 
Type of Sponsor  Research institution and hospital 
 
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 O N Nikkila Mai  Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER)  Department of Anaesthesiology and Critical Care, 2nd floor, Institute block, JIPMER, Dhanvantri nagar, Puducherry-605006
Pondicherry
PONDICHERRY 		 9100099724

nikkinivas@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JIPMER INSTITUTIONAL ETHICS COMMITTEE  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 supraclavicular subclavian vein cannulation using Anterior Out-of-plane approach.  To compare the First pass success rate between inplane and anterior out-of-plane approach in ultrasound guided supraclavicular subclavian vein cannulation. Secondarily, To compare in-plane and anterior out-of-plane approach in ultrasound guided supraclavicular vein cannulation in terms of: Time taken for successful cannulation Time for venous puncture Operator satisfaction using Likert scale Complications (such as pneumothorax, arterial puncture)  
Comparator Agent  Ultrasound guided supraclavicular subclavian vein cannulation using In-Plane approach.  To compare the First pass success rate between inplane and anterior out-of-plane approach in ultrasound guided supraclavicular subclavian vein cannulation. Secondarily, To compare in-plane and anterior out-of-plane approach in ultrasound guided supraclavicular vein cannulation in terms of: Time taken for successful cannulation Time for venous puncture Operator satisfaction using Likert scale Complications (such as pneumothorax, arterial puncture) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Inclusion criteria- Patients over 18 years of age admitted in JIPMER for elective surgeries requiring a central venous access in perioperative period  
 
ExclusionCriteria 
Details  Exclusion criteria-
Patients with Coagulation Disorders
Scar or Infection over puncture site on neck
Chest wall or neck deformity 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
To compare the First pass success rate between inplane and anterior out-of-plane approach in ultrasound guided supraclavicular subclavian vein cannulation.   1.Time at which flashback occurs in the needle from time of needle insertion.
2. Time till aspiration in all three lumens of the catheter is confirmed.
First pass success Rate: Successful attempt is defined as the single pass from needle prick to aspiration of blood from all the three lumens of the catheter inserted. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare in-plane and anterior out-of-plane approach in ultrasound guided supraclavicular vein cannulation in terms of:
1. Time taken for successful cannulation
2. Time for venous puncture
3. Operator satisfaction using Likert scale
4. Complications (such as pneumothorax, arterial puncture)  		 Time from needle insertion till successful aspiration of blood from all three lumens will be taken as Time for successful cannulation.
Time till aspiration of venous blood into the syringe following skin puncture will be taken as Time for venous puncture. 
 
Target Sample Size   Total Sample Size="128"
Sample Size from India="128" 
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)   05/09/2022 
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   Not done 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  
After obtaining approval from the Department research monitoring committee, Institute Ethics committee, and completing CTRI registration, study will be started. Patients satisfying the eligibility criteria will be identified and enrolled in the study. After explaining the procedure, a written informed consent as per ICMR guidelines will be taken. Demographic variables of the patient like age, gender, weight and height will be noted.

Once the patient is shifted inside the operation theater, standard monitoring devices including the pulse oximetry, Non-Invasive Blood pressure cuff, ECG leads will be attached and continuous monitoring of vitals will be done. General anesthesia and Intubation will be carried out by the attending anesthesiologist.

With patient lying supine and arm adducted by side, neck is extended and head is turned to the opposite side at an angle of 30 degrees. A wedge is placed in between the shoulder blades. Linear Ultrasound probe of frequency 8-15MHz will be used for this procedure. Under sterile precautions required for the placement of a central venous catheter, the procedure will be started.

Ultrasound probe will be held with the left hand and the needle with the right hand. The probe will be placed on the right side of the neck, at the level of cricoid cartilage so as to visualize IJV in short axis. Once IJV is identified, the probe is moved caudally down the neck, tracing the course of IJV. When it reaches the superior border of the clavicle, the probe will be angulated to visualize the confluence of IJV with subclavian vein as they form the brachiocephalic vein. The probe is adjusted so as to bring the vein to the center of ultrasound screen. Pleura should also be visualized in the same frame. The depth of vein from skin surface is noted.

GROUP 1 ± IN-PLANE APPROACH With ultrasound probe held abutting the superior border of the clavicle and keeping the vein in view, a central vein catheter needle is inserted at lateral border on the side of footprint of transducer at an angle of 45 degrees to the axis of the probe and to skin surface. The needle is slowly advanced and its entire path as it passes through the fascial tissues is visualized under ultrasound. Flashback or aspiration of free flow of venous blood in the syringe and visualization of needle tip position using ultrasound helps in confirming the entry into the subclavian vein. The probe is then kept aside and needle is stabilized by holding it at skin entry point. After successful venous puncture, catheterization is done using the Seldinger technique. Aspiration of blood from each of the three lumens is confirmed before suturing the catheter onto the skin. A sterile dressing is applied over the catheter.

GROUP 2 ± OUT-OF-PLANE APPROACH: With the ultrasound probe placed parallel to the clavicle and angulated optimally to keep vein in view, depth from the skin surface to the vein is measured. The needle is inserted at the centre of footprint of the ultrasound probe, in between clavicle and probe at an angle of 5 to 10 degrees to the axis of the probe, directing the needle towards the vein, under vision. Keeping the depth noted earlier in mind, the skin will be pierced with a central vein catheter needle. Care will be taken to ensure that needle will not be inserted more than the measured depth in ultrasound.
Its entry into the vein is visualized in ultrasound view and until there is flashback or free aspiration of blood in the syringe attached to the needle. Once free flow of venous blood is confirmed, the ultrasound probe is kept aside and with the left hand, needle is held at skin entry point to stabilize it to prevent inadvertent insertion into deeper structures. The hypothenar eminence of the same hand is rested over the sternum of the patient for stability. After successful venous puncture, catheterization is done using the Seldinger technique. Aspiration of blood from each of the three lumens is confirmed before suturing the catheter onto the skin. A sterile dressing is applied over the catheter.

A successful attempt is defined as the single pass from needle prick to aspiration of blood from all the three lumens of the catheter inserted without any additional skin punctures/ additional vein punctures). Additional skin punctures/ vein punctures will be noted.

Number of needle redirections, if any, will be noted. Needle redirection is defined as withdrawal of needle till the subcutaneous plane and redirecting it towards the vein.

In both groups, an assistant will set a timer to note the various timelines along the procedure. The timer will start with needle insertion. The time at which flashback occurs in the syringe will be noted next. Finally, once the aspiration of blood from each of the three lumens of the catheter is confirmed, the final time reading will be taken.

Time from needle insertion till successful aspiration of blood from all three lumens will be taken as ‘Time for successful Cannulation’.  Time till aspiration of venous blood into the syringe following skin puncture will be taken as ‘Time for venous Punture’.

At the end of the procedure, ease of using the technique is measured with a 5-point Likert scale (Poor/ Fair/ Neutral/ Good/ Excellent) as assessed by the operator. A chest radiograph will be taken in the postoperative period to confirm the position of the catheter and identify pneumothorax. Using the above data collected, outcomes of the procedures in two groups will be noted and compared statistically.

In both groups, the procedure will be done by anesthesiologists who have done a minimum of 20 successful subclavian vein cannulation.

 
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