Central Venous CatheterizationNCT04962945
Comparison of the Oblique-axis and Long-axis Approaches for Axillary Vein Catheterization Under Ultrasound Guidance
A study testing Oblique-axis approach group and Long-axis approach group in people with Central Venous Catheterization, run by Guowei Tu at 1 site in China.
Trial summary
Ultrasound-guided axillary vein catheterization can be performed via the oblique-axis and long-axis approaches of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided axillary vein catheterization in cardiac surgical patients… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Central Venous Catheterization
- What is being tested?
- Oblique-axis approach group and Long-axis approach group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2021to 31 Dec 2024
- 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
- Cardiac surgical patients in Cardiac Surgery Intensive Care Unit
- Axillary vein catheterization is needed according to the clinical practice
Who cannot join
- the proximal and/or distal axillary vein was not clearly visualized or potentially unavailable for catheterization;
- did not receive or had not received oral antiplatelet drugs and/or anticoagulants for less than 3 days;
- already had presence of subclavian or axillary vein catheter;
- required an emergency axillary vein catheterization;
- had fracture of the ipsilateral clavicle or anterior proximal ribs;
- had subclavian and/or axillary vein thrombosis;
- had local infection of the puncture area.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan hospital, Fudan university
Shanghai, 200030
Guo-wei F Tu, MD, +86-021-64041990, tu.guowei@zs-hospital.sh.cn
Ying Su, MD, +86-021-64041990, su.ying@zs-hospital.sh.cn
About this study
Official title: Comparison of the Oblique-axis and Long-axis Approaches for Axillary Vein Catheterization Under Ultrasound Guidance in Cardiac Surgery Patients Susceptible to Bleeding: a Randomized Controlled Trial
Ultrasound-guided axillary vein catheterization can be performed via the oblique-axis and long-axis approaches of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided axillary vein catheterization in cardiac surgical patients with high bleeding risk
Read the detailed description
For patients after cardiac surgery, antiplatelet drugs or anticoagulants are usually used for preventing thrombosis. Use of those drugs is associated with increased risk of bleeding. Any invasive procedures may put those patients at additional risk of bleeding. Ultrasound (US) has become widely accepted to guide safe and accurate central venous catheterization. Ultrasound-guided axillary vein catheterization can be performed via the oblique-axis and long-axis approaches of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided axillary vein catheterization in cardiac surgical patients with high bleeding risk
- Conditions
- Central Venous Catheterization
- Being tested
- Oblique-axis approach group, Long-axis approach group
- Keywords
- axillary vein, central venous catheterization, ultrasound, cardiac surgery, complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oblique-axis approach groupProcedure or surgery
The first two attempts via the oblique-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the long-axis approach.
Long-axis approach groupProcedure or surgery
The first two attempts via the long-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the oblique-axis approach.
| Study group | Role | What they receive |
|---|---|---|
| Oblique-axis approach group | Active comparator | The first two attempts via the oblique-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the long-axis approach. Receives: Procedure: Oblique-axis approach group |
| Long-axis approach group | Active comparator | The first two attempts via the long-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the oblique-axis approach. Receives: Procedure: Long-axis approach group |
What is being measured
The primary outcome is the main question the study is designed to answer.
First puncture success rate
Central venous catheter established upon first punction attempt
Measured: approximately 3-5 minutes
Secondary outcomes (6)
approach success rate
the number of successful cannulation within the first two attempts
Measured: within 1 hours
strategy success rate
defined as the number of successful cannulation in targeted axillary vein within four attempts (the first two attempts using the randomized approach, third and fourth attempts using the non-randomized approach)
Measured: within 1 hours
the number of attempts
the number of attempts until successful cannulation
Measured: within 1 hours
access time
defined as the time between penetration of skin and aspiration of venous blood into the syringe
Measured: within 1 hours
time to successful cannulation
the time from skin puncture until completion of cannula insertion
Measured: within 1 hours
Complications rate
Complications included arterial puncture, pneumothorax, haemothorax, nerve injuries, hematoma, catheter misplacement
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2021
- Study start6 Jul 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterizationStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guowei Tu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Guowei Tu, Shanghai Zhongshan Hospital
- Investigators
- Zhe Luo, Professor, Study director, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962945
- Sponsor's protocol ID
- B2021-018R
- Status last verified
- Jul 2021
- First submitted
- 5 Jul 2021
- Last updated
- 20 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Oblique-axis and Long-axis Approaches for Axillary Vein Catheterization Under Ultrasound Guidance in Cardiac Surgery Patients Susceptible to Bleeding: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04962945
- Acronym / sponsor ID
- B2021-018R
- Conditions
- Central Venous Catheterization
- Keywords
- axillary vein, central venous catheterization, ultrasound, cardiac surgery, complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Guowei TuUniversity, hospital or other
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 15 Jul 2021 (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.
Ultrasound-guided axillary vein catheterization can be performed via the oblique-axis and long-axis approaches of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided axillary vein catheterization in cardiac surgical patients with high bleeding risk
Detailed description
For patients after cardiac surgery, antiplatelet drugs or anticoagulants are usually used for preventing thrombosis. Use of those drugs is associated with increased risk of bleeding. Any invasive procedures may put those patients at additional risk of bleeding. Ultrasound (US) has become widely accepted to guide safe and accurate central venous catheterization. Ultrasound-guided axillary vein catheterization can be performed via the oblique-axis and long-axis approaches of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided axillary vein catheterization in cardiac surgical patients with high bleeding risk
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oblique-axis approach group | Active comparator | Procedure: Oblique-axis approach groupThe first two attempts via the oblique-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the long-axis approach. |
| Long-axis approach group | Active comparator | Procedure: Long-axis approach groupThe first two attempts via the long-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the oblique-axis approach. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cardiac surgical patients in Cardiac Surgery Intensive Care Unit
- Axillary vein catheterization is needed according to the clinical practice
Key exclusion criteria (7 listed)
- the proximal and/or distal axillary vein was not clearly visualized or potentially unavailable for catheterization;
- did not receive or had not received oral antiplatelet drugs and/or anticoagulants for less than 3 days;
- already had presence of subclavian or axillary vein catheter;
- required an emergency axillary vein catheterization;
- had fracture of the ipsilateral clavicle or anterior proximal ribs;
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 |
|---|---|---|
| Oblique-axis approach groupThe first two attempts via the oblique-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the long-axis approach. | Procedure or surgery | Oblique-axis approach group |
| Long-axis approach groupThe first two attempts via the long-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the oblique-axis approach. | Procedure or surgery | Long-axis approach group |
Primary outcome
First puncture success rate
Time frame: approximately 3-5 minutes
Central venous catheter established upon first punction attempt
6 secondary outcomes
approach success rate
Time frame: within 1 hours
strategy success rate
Time frame: within 1 hours
the number of attempts
Time frame: within 1 hours
access time
Time frame: within 1 hours
time to successful cannulation
Time frame: within 1 hours
Complications rate
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Individual participant dataSharing planned: Undecided
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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.
Zhe Luo, Professor study director
Fudan 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 Oblique-axis approach group and Long-axis approach group in people with Central Venous Catheterization, run by Guowei Tu at 1 site in China.
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 2 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 20 Jul 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Guo-wei Tu, MD (+86-021-64041990, tu.guowei@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First puncture success rate (time frame: approximately 3-5 minutes). 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 20 Jul 2021.