Central Venous CatheterUSICNCT04637347
SC vs IC Approach for US-guided SC Vein Catheterization
A study testing Catheterization approach in people with Central Venous Catheter, run by University Tunis El Manar at 1 site in Tunisia.
Trial summary
Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization. For IP-ISV cannulation, a linear transducer is placed in the infraclavicular fossa. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Central Venous Catheter
- What is being tested?
- Catheterization approach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Dec 2020to 30 Jun 2021
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients admitted in intensive care unit requiring a central venous catheter (CVC)
Who cannot join
- Major blood coagulation disorders,
- Any thrombotic formations within the vein,
- Congenital or acquired deformity of neck or clavicle
- Cannulation site infection, hematoma and surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparaison Between Ultrasound-guided Supraclavicular and Infraclavicular Approaches for Subclavian Venous Catheterization in Intensive Care Unit
Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.
For IP-ISV cannulation, a linear transducer is placed in the infraclavicular fossa. After obtaining a long-axis view of the axillary vein and distal subclavian vein ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the vein while noticing the lung pleura underneath the vessels.
For IP-SSV cannulation, a short-axis view of the IJV is obtained first. The probe is slid caudally following the IJV until getting the best long-axis view of the SCV. Using an in-plane approach, the needle is inserted at the base of the transducer at a 30° angle and advanced under the long axis under real-time US guidance targeting the SCV.
Read the detailed description
Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.
For IP -ISV, the Linear transducer is placed perpendicularly and inferior to clavicle. Transverse (short axis) view of subclavian vein (SCV), subclavian artery (SCA) and pleura is first obtained. With SCV centrally positioned, the transducer is rotated 90° clockwise until longitudinal view of subclavian vein is obtained. Pulse-wave Doppler view of the SCV confirms non-pulsatile flow and identifies the vessel. The needle is than inserted in the midpoint of the small footprint transducer using the in-plane approach. The needle is advanced slowly, under real-time US guidance targeting the SCV, taking note of the lung pleura underneath the vessels.
For IP-SSV cannulation, a short-axis view of the IJV is first obtained . The probe is slid caudally following the IJV until the junction of the subclavian vein (SCV) and IJV is reached in the supraclavicular fossa. The probe is then turned slightly and tilted anteriorly to get the best long-axis view of the SCV and the brachiocephalic vein .
Using an in-plane approach, the needle attached to a syringe is inserted at the base of the transducer at a 30° angle and advanced strictly under the long axis of the US probe from lateral to medial. The needle point is then guided.
In both groups, catheterization was done through Seldinger technique.
- Conditions
- Central Venous Catheter
- Being tested
- Catheterization approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catheterization approachDevice
In plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization
| Study group | Role | What they receive |
|---|---|---|
| IP-ISV | Other | In plane infraclavicular subclavian vein catheterization Receives: Device: Catheterization approach |
| IP-SSV | Other | In plane supraclavicular subclavian vein catetherization Receives: Device: Catheterization approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall access time
Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire into vein.
Measured: During the venous cannulation procedure
The guidewire time
Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire into the vein
Measured: During the venous cannulation procedure
The venous access time
he time between the first skin puncture and free aspiration of venous blood in the syringe
Measured: During the venous cannulation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2020
- Study start1 Dec 2020
- Primary completion31 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trabelsi Becem, University Tunis El Manar
- Investigators
- BEN ALI MECHAAL, PROFESSOR, Study chair, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04637347
- Sponsor's protocol ID
- CIS UTSCVC
- Acronym
- USIC
- Status last verified
- Aug 2021
- First submitted
- 14 Nov 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparaison Between Ultrasound-guided Supraclavicular and Infraclavicular Approaches for Subclavian Venous Catheterization in Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04637347
- Acronym / sponsor ID
- USIC / CIS UTSCVC
- Conditions
- Central Venous Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 19 Nov 2020 (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.
Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.
For IP-ISV cannulation, a linear transducer is placed in the infraclavicular fossa. After obtaining a long-axis view of the axillary vein and distal subclavian vein ,the needle is inserted in the midpoint of the small footprint transducer. Then,the needle is advanced under real-time US guidance until visualizing the tip of the needle inside the vein while noticing the lung pleura underneath the vessels.
For IP-SSV cannulation, a short-axis view of the IJV is obtained first. The probe is slid caudally following the IJV until getting the best long-axis view of the SCV. Using an in-plane approach, the needle is inserted at the base of the transducer at a 30° angle and advanced under the long axis under real-time US guidance targeting the SCV.
Detailed description
Patients were randomly divided into two groups: ultrasound-guided (US-guided) in-plane infraclavicular subclavian vein (IP-ISV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.
For IP -ISV, the Linear transducer is placed perpendicularly and inferior to clavicle. Transverse (short axis) view of subclavian vein (SCV), subclavian artery (SCA) and pleura is first obtained. With SCV centrally positioned, the transducer is rotated 90° clockwise until longitudinal view of subclavian vein is obtained. Pulse-wave Doppler view of the SCV confirms non-pulsatile flow and identifies the vessel. The needle is than inserted in the midpoint of the small footprint transducer using the in-plane approach. The needle is advanced slowly, under real-time US guidance targeting the SCV, taking note of the lung pleura underneath the vessels.
For IP-SSV cannulation, a short-axis view of the IJV is first obtained . The probe is slid caudally following the IJV until the junction of the subclavian vein (SCV) and IJV is reached in the supraclavicular fossa. The probe is then turned slightly and tilted anteriorly to get the best long-axis view of the SCV and the brachiocephalic vein .
Using an in-plane approach, the needle attached to a syringe is inserted at the base of the transducer at a 30° angle and advanced strictly under the long axis of the US probe from lateral to medial. The needle point is then guided.
In both groups, catheterization was done through Seldinger technique.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IP-ISV | Other | Device: Catheterization approachIn plane infraclavicular subclavian vein catheterization |
| IP-SSV | Other | Device: Catheterization approachIn plane supraclavicular subclavian vein catetherization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted in intensive care unit requiring a central venous catheter (CVC)
Key exclusion criteria (4 listed)
- Major blood coagulation disorders,
- Any thrombotic formations within the vein,
- Congenital or acquired deformity of neck or clavicle
- Cannulation site infection, hematoma and surgery.
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 |
|---|---|---|
| Catheterization approachIn plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization | Device | IP-ISV, IP-SSV |
Primary outcome
The overall access time
Time frame: During the venous cannulation procedure
Time from the ultrasound scanning to the ultrasound confirmation of the correct position of the guidewire into vein.
The guidewire time
Time frame: During the venous cannulation procedure
Time from the first skin puncture to the ultrasound confirmation of the correct placement of the guidewire into the vein
The venous access time
Time frame: During the venous cannulation procedure
he time between the first skin puncture and free aspiration of venous blood in the syringe
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 25 Aug 2021.
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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.
BEN ALI MECHAAL, PROFESSOR study chair
University Tunis El Manar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Catheterization approach in people with Central Venous Catheter, run by University Tunis El Manar at 1 site in Tunisia.
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 4 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 25 Aug 2021. 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 Tunisia. 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?
The overall access time (time frame: During the venous cannulation procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Aug 2021.