Central Venous CatheterIPSSCVCNCT03879954
US-guided OOP Internal Jugular Vein Vs IP Supraclavicular Subclavian Vein Catheterization in ICU
A study testing Catetherization 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) out-of-plane internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization. For OOP-IJV cannulation, the transducer was placed to identify IJV in short-axis view. 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?
- Catetherization approach
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteTunisia
- Study dates
- 26 Feb 2019to 26 Nov 2019
- 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: Comparison Between Ultrasound-guided Out-of-plane Internal Jugular Vein and In-plane Supraclavicular Subclavian Vein Catheterization in Intensive Care Unit Patients-a Randomized Trial
Patients were randomly divided into two groups: ultrasound-guided (US-guided) out-of-plane internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.
For OOP-IJV cannulation, the transducer was placed to identify IJV in short-axis view. The needle was introduced at an angle of 60° to the skin surface, and advanced under real-time US guidance until visualizing the tip of the needle inside the vein.
For IP-SSV cannulation, a short-axis view of the IJV was obtained first. The probe was slid caudally following the IJV until getting the best long-axis view of the SCV. Using an in-plane approach, the needle was 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) out-of-plane internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.
For OOP-IJV cannulation, the transducer was placed on transverse position over the patient's neck at the level of the cricoid cartilage to identify IJV and carotid artery (CA) in short-axis view. The vein was then centered on the screen. The skin puncture was made in the center of the US image using a needle attached to a syringe. The needle was introduced at an angle of 60° to the skin surface, perpendicular to the transducer, and advanced under real-time US guidance toward the IJV until visualizing the tip of the needle inside the vein.
For IP-SSV cannulation, a short-axis view of the IJV was obtained first. The probe was slid caudally following the IJV until the junction of the subclavian vein (SCV) and IJV was reached in the supraclavicular fossa. The probe was then turned slightly and tilted anteriorly to get the best long-axis view of the SCV and the brachiocephalic vein (BCV).
Using an in-plane approach, the needle attached to a syringe was 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 was then guided under real-time US guidance targeting the SCV.
In both groups, catheterization was done through Seldinger technique.
- Conditions
- Central Venous Catheter
- Being tested
- Catetherization approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catetherization approachDevice
Out of plane inetrnal jugular vein Vs in plane supraclavicular subclavian vein catetherization
| Study group | Role | What they receive |
|---|---|---|
| OOP-IJV | Other | Out of plane inetrnal jugular vein catetherization Receives: Device: Catetherization approach |
| IP-SSV | Other | in plane supraclavicular subclavian vein catetherization Receives: Device: Catetherization 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
Secondary outcomes (2)
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
The 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 Mar 2019
- Study start26 Feb 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 250 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
- NCT03879954
- Sponsor's protocol ID
- UTEM SSCV
- Acronym
- IPSSCVC
- Status last verified
- Dec 2019
- First submitted
- 2 Mar 2019
- Last updated
- 17 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Trabelsi B, Hajjej Z, Drira D, Yedes A, Labbene I, Ferjani M, Ben Ali M. Comparison of ultrasound-guided internal jugular vein and supraclavicular subclavian vein catheterization in critically ill patients: a prospective, randomized clinical trial. Ann Intensive Care. 2022 Oct 1;12(1):91. doi: 10.1186/s13613-022-01065-x.
PubMed 36183049
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Ultrasound-guided Out-of-plane Internal Jugular Vein and In-plane Supraclavicular Subclavian Vein Catheterization in Intensive Care Unit Patients-a Randomized Trial
- ClinicalTrials.gov ID
- NCT03879954
- Acronym / sponsor ID
- IPSSCVC / UTEM SSCV
- Conditions
- Central Venous Catheter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 26 Feb 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 19 Mar 2019 (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) out-of-plane internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.
For OOP-IJV cannulation, the transducer was placed to identify IJV in short-axis view. The needle was introduced at an angle of 60° to the skin surface, and advanced under real-time US guidance until visualizing the tip of the needle inside the vein.
For IP-SSV cannulation, a short-axis view of the IJV was obtained first. The probe was slid caudally following the IJV until getting the best long-axis view of the SCV. Using an in-plane approach, the needle was 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) out-of-plane internal jugular vein (OOP-IJV) and in-plane supraclavicular subclavian vein (IP-SSV) catheterization.
For OOP-IJV cannulation, the transducer was placed on transverse position over the patient's neck at the level of the cricoid cartilage to identify IJV and carotid artery (CA) in short-axis view. The vein was then centered on the screen. The skin puncture was made in the center of the US image using a needle attached to a syringe. The needle was introduced at an angle of 60° to the skin surface, perpendicular to the transducer, and advanced under real-time US guidance toward the IJV until visualizing the tip of the needle inside the vein.
For IP-SSV cannulation, a short-axis view of the IJV was obtained first. The probe was slid caudally following the IJV until the junction of the subclavian vein (SCV) and IJV was reached in the supraclavicular fossa. The probe was then turned slightly and tilted anteriorly to get the best long-axis view of the SCV and the brachiocephalic vein (BCV).
Using an in-plane approach, the needle attached to a syringe was 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 was then guided under real-time US guidance targeting the SCV.
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 |
|---|---|---|
| OOP-IJV | Other | Device: Catetherization approachOut of plane inetrnal jugular vein catetherization |
| IP-SSV | Other | Device: Catetherization 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 |
|---|---|---|
| Catetherization approachOut of plane inetrnal jugular vein Vs in plane supraclavicular subclavian vein catetherization | Device | IP-SSV, OOP-IJV |
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.
2 secondary outcomes
The guidewire time
Time frame: During the venous cannulation procedure
The venous access time
Time frame: During the venous cannulation 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 17 Dec 2019.
- Derived from this study: PubMed 36183049Trabelsi B, Hajjej Z, Drira D, Yedes A, Labbene I, Ferjani M, Ben Ali M. Comparison of ultrasound-guided internal jugular vein and supraclavicular subclavian vein catheterization in critically ill patients: a prospective, randomized clinical trial. Ann Intensive Care. 2022 Oct 1;12(1):91. doi: 10.1186/s13613-022-01065-x.
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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 Catetherization 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 17 Dec 2019. 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). 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 NCT03879954, which also lists 1 linked publication.
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 17 Dec 2019.