Infraclavicular Vein CannulationNCT06761326
Right Versus Left Distal Axillary Vein Cannulation
A study testing Ultrasound guided right infraclavicular approach of subclavian vein cannulation and Ultrasound guided left infraclavicular approach of subclavian vein cannulation in people with Infraclavicular Vein Cannulation and Venous Cannulation, run by Alexandria University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Infraclavicular Vein Cannulation, Venous Cannulation
- What is being tested?
- Ultrasound guided right infraclavicular approach of subclavian vein cannulation and Ultrasound guided left infraclavicular approach of subclavian vein cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Oct 2024to 2 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- .Patients requiring porta Cath insertion.
Who cannot join
- Abnormalities in the platelet count or coagulation
- Thrombosis of the target vein
- Soft tissue infection of the overlying area
- Fracture of the clavicle or proximal ribs
- Patients with pacemakers or defibrillators
- Malignant superior vena cava syndrome
Show all 9Show fewer
- Gross obesity
- History of prior catheterization of the subclavian vein
- Patient refusal to participate in the study.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Medical Research Institute
Alexandria, Alexandria Governorate, 21561
About this study
Official title: RIGHT VERSUS LEFT ULTRASOUND-GUIDED DISTAL AXILLARY VEIN CANNULATION FOR TOTALLY IMPLANTABLE VENOUS ACCESS DEVICE PLACEMENT: A PROSPECTIVE RANDOMIZED EXPLORATORY STUDY
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
Read the 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 .
- Being tested
- Ultrasound guided right infraclavicular approach of subclavian vein cannulation, Ultrasound guided left infraclavicular approach of subclavian vein cannulation
- Keywords
- subclavian vein cannulation, ultrasound guided, fluroscopy, maldirection, infraclavicular approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided right infraclavicular approach of subclavian vein cannulationProcedure or surgery
All patients will be in supine position, with the arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image.The probe will be placed in he parasgittal plane in the deltopectoral groove medial to the coracoid process . The image will be optimized regarding the depth , focus and the gain accorgingly 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 inplane 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.
Ultrasound guided left infraclavicular approach of subclavian vein cannulationProcedure or surgery
All patients will be in supine position, with the arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image.The probe will be placed in he parasgittal plane in the deltopectoral groove medial to the coracoid process . The image will be optimized regarding the depth , focus and the gain accorgingly 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 inplane 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.
| Study group | Role | What they receive |
|---|---|---|
| Right subclavian vein cannulation | Other | All patients will be in supine position, with the right arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image. The probe will be placed in he parasagittal plane in the deltopectoral groove of the right side , medial to the coracoid process . The image will be optimized for the best image of the right 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 right 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. Receives: Procedure: Ultrasound guided right infraclavicular approach of subclavian vein cannulation |
| Left subclavian vein cannulation | Experimental | All patients will be in supine position, with the left arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image. The probe will be placed in he parasagittal plane in the left 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 left 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. Receives: Procedure: Ultrasound guided left infraclavicular approach of subclavian vein cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Successful cannulation
Recognition of the catheter in the SVC by fluoroscopy
Measured: Directly after the end of the procedure
Secondary outcomes (2)
Rate of malposition identified by the ultrasound
The ultrasound probe will be positioned on the internal jugular vein for the recognition of malposition of the guidewire
Measured: Directly after the insertion of the guidewire and the catheter
Complication of the procedures
All the complications will be recognized and reported
Measured: Directly at the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start21 Oct 2024
- Primary completion1 Jul 2026
- Study completion2 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Infraclavicular Vein CannulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled pilot study
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Engi Yousry, Alexandria University
- Investigators
- Engi Y Hashem, MD, Principal investigator, Medical research institute , Alexandria university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761326
- Sponsor's protocol ID
- Axillary vein cannulation
- Status last verified
- Oct 2026
- First submitted
- 10 Oct 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: unfortunately there is no web site for the publication of results , but whoever is interested in the study can contact the main author
Publications
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.
PubMed 34231204Imai 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.
PubMed 37476443Hosur 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.
PubMed 38506879
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RIGHT VERSUS LEFT ULTRASOUND-GUIDED DISTAL AXILLARY VEIN CANNULATION FOR TOTALLY IMPLANTABLE VENOUS ACCESS DEVICE PLACEMENT: A PROSPECTIVE RANDOMIZED EXPLORATORY STUDY
- ClinicalTrials.gov ID
- NCT06761326
- Acronym / sponsor ID
- Axillary vein cannulation
- Keywords
- subclavian vein cannulation, ultrasound guided, fluroscopy, maldirection, infraclavicular approach
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 2 Aug 2026 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled pilot study
| Arm | Type | Receives |
|---|---|---|
| Right subclavian vein cannulation | Other | Procedure: Ultrasound guided right infraclavicular approach of subclavian vein cannulationAll patients will be in supine position, with the right arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image. The probe will be placed in he parasagittal plane in the deltopectoral groove of the right side , medial to the coracoid process . The image will be optimized for the best image of the right 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 right 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. |
| Left subclavian vein cannulation | Experimental | Procedure: Ultrasound guided left infraclavicular approach of subclavian vein cannulationAll patients will be in supine position, with the left arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image. The probe will be placed in he parasagittal plane in the left 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 left 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. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- .Patients requiring porta Cath insertion.
Key exclusion criteria (9 listed)
- Abnormalities in the platelet count or coagulation
- Thrombosis of the target vein
- Soft tissue infection of the overlying area
- Fracture of the clavicle or proximal ribs
- Patients with pacemakers or defibrillators
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided right infraclavicular approach of subclavian vein cannulationAll patients will be in supine position, with the arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image.The probe will be placed in he parasgittal plane in the deltopectoral groove medial to the coracoid process . The image will be optimized regarding the depth , focus and the gain accorgingly 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 inplane 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. | Procedure or surgery | Right subclavian vein cannulation |
| Ultrasound guided left infraclavicular approach of subclavian vein cannulationAll patients will be in supine position, with the arm abducted to 45 degrees , the angle of the arm will be increased to 90 degrees to best acquire the image.The probe will be placed in he parasgittal plane in the deltopectoral groove medial to the coracoid process . The image will be optimized regarding the depth , focus and the gain accorgingly 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 inplane 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. | Procedure or surgery | Left subclavian vein cannulation |
Primary outcome
Incidence of Successful cannulation
Time frame: Directly after the end of the procedure
Recognition of the catheter in the SVC by fluoroscopy
2 secondary outcomes
Rate of malposition identified by the ultrasound
Time frame: Directly after the insertion of the guidewire and the catheter
Complication of the procedures
Time frame: Directly at the end of the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Background: PubMed 34231204Kim 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.
- Background: PubMed 37476443Imai 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.
- Background: PubMed 38506879Hosur 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.
- Individual participant dataSharing planned: No. unfortunately there is no web site for the publication of results , but whoever is interested in the study can contact the main author
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Engi Y Hashem, MD principal investigator
Medical research institute , Alexandria university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided right infraclavicular approach of subclavian vein cannulation and Ultrasound guided left infraclavicular approach of subclavian vein cannulation in people with Infraclavicular Vein Cannulation and Venous Cannulation, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Successful cannulation (time frame: Directly after the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761326, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.