Clinical trial NCT06761326: Right Versus Left Infraclavicular Approach for Subclavian Vein Cannulation
Official title: Right Versus Left Ultrasound Guided Infraclavicular Approach for Subclavian Vein Cannulation: a Randomized Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infraclavicular Vein Cannulation
Venous Cannulation
Keywords: subclavian vein cannulation
ultrasound guided
fluroscopy
maldirection
infraclavicular approach
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled pilot study
Primary purpose: TREATMENT

Brief summary: Central venous cannulation is an essential procedure in the anaesthetic and critical care practice. Ultrasound has revolutionized the practice favoring the internal jugular cannulation to the other sites .Subcalvian vein cannulation has fallen out of favor mainly due to the difficult visualization with the ultrasound, especially in obese patients and the inevitable position of the clavicle acting as a bony obstacle , in addition to the anatomical position in vicinity to the pleura which might raise the risk of pneumothorax . Indeed the subclavian vein cannulation is more comfortable and tolerated by the patient especially those requiring long term intravenous therapy, with less rates of infection and thrombosis. This mandated the development of a safer and efficient technique for the cannulation empowered by the ultrasound technology.

The infracalvicular approach or the proximal axillary vein cannulation has been described but is not popular. It provides a potentially safer and successful technique with less complication both in "experienced" and "less experienced"operators . All the patients will receive general anaesthesia with laryngeal mask insertion . Careful sterilization of the surgical site and strict aseptic techniques for the handling of the ultrasound probe will be pursued

Detailed description: All patients will be in supine position, with the arm abducted to 45 degrees , the angle of the arm will be adjusted to acquire best image. The probe will be placed in he parasagittal plane in the deltopectoral groove medial to the coracoid process . The image will be optimized regarding the depth , focus and the gain accordingly for the best image of the axillary artery and vein similar to that acquired when performing an infraclavicular approach for brachial plexus block . The probe will be rotated to obtain a longitudinal image of the axillary vein . The needle will be introduced in real time imaging , in an in-plane technique and blood will be aspirated , the guidewire will be introduced in real time imaging .The internal jugular vein will be scanned bilaterally via ultrasonography to exclude malposition of the guidewire and will be reported in case of such. The catheter will be introduced through the sheath and will be tunneled the skin, Infraclavicular incision will be performed for the port site , the port will be secured in a dissected pocket right above the pectoralis major muscle .Flush back will be confirmed from the port .The incision will be closed in layers .The final position of the catheter tip will be confirmed using fluoroscopic guidance. In case of difficult visualization or failure of cannulation of one side , the subclavian vein of the contralateral side will be scanned and cannulated . The internal jugular vein will be the cannulated instead if any further difficulties were encountered .

Eligibility criteria: Inclusion Criteria:

.Patients requiring porta Cath insertion.

Exclusion Criteria:

.Abnormalities in the platelet count or coagulation .

.Thrombosis of the target vein, .Soft tissue infection of the overlying area.

Primary outcomes:
measure: Incidence of Successful cannulation
timeFrame: Directly after the end of the procedure
Secondary outcomes:
measure: Rate of malposition identified by the ultrasound
timeFrame: Directly after the insertion of the guidewire and the catheter
measure: Complication of the procedures
timeFrame: Directly at the end of the procedure
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Medical Research Institute
Study officials:
affiliation: Medical research institute , Alexandria university
name: Engi Y Hashem, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YJ, Ma S, Yoon HK, Lee HC, Park HP, Oh H. Supraclavicular versus infraclavicular approach for ultrasound-guided right subclavian venous catheterisation: a randomised controlled non-inferiority trial. Anaesthesia. 2022 Jan;77(1):59-65. doi: 10.1111/anae.15525. Epub 2021 Jul 6.
citation: Imai E, Watanabe J, Okano H, Yokozuka M. Efficacy and safety of supraclavicular versus infraclavicular approach for subclavian vein catheterisation: An updated systematic review and meta-analysis of randomised controlled trials. Indian J Anaesth. 2023 Jun;67(6):486-496. doi: 10.4103/ija.ija_837_22. Epub 2023 Jun 14.
citation: Hosur Ravikumar R, Majage S, Prasanna M, Ray BR. Comparison of ultrasound guided supraclavicular subclavian vein versus infraclavicular subclavian/axillary vein catheterization: A systematic review and meta analysis. J Vasc Access. 2025 Mar;26(2):633-640. doi: 10.1177/11297298241239092. Epub 2024 Mar 20.