Comparison of two different approaches to subclavian vein puncture with ultrasound guidance
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2022/09/045231
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 128
Inclusion criteria- Patients over 18 years of age admitted in JIPMER for elective surgeries requiring a central venous access in perioperative period.
Exclusion criteria- Patients with Coagulation Disorders Scar or Infection over puncture site on neck Chest wall or neck deformity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Measures
Name Time Method 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
Trial Locations
- Locations (1)
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER)
🇮🇳Pondicherry, PONDICHERRY, India
Jawaharlal Institute of Postgraduate Medical Education and Research ( JIPMER)🇮🇳Pondicherry, PONDICHERRY, IndiaDr O N Nikkila MaiPrincipal investigator9100099724nikkinivas@gmail.com