Complication of TreatmentNCT03677765
Comparisons of Complications Related to Two Approaches of Ultrasonography-guided Subclavian Venous Catheterization
A study testing Supra- vs Infraclavicular approach using ultrasonography in people with Complication of Treatment and Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
For performing subclavian venous catheterization, two approaches (supraclavicular and infraclavicular) have been used successfully in various clinical practice. However, there remains controversy concerning which approach is safer and causes less complications during ultrasonography-guided subclavian venous… Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Complication of Treatment, Catheterization
- What is being tested?
- Supra- vs Infraclavicular approach using ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Nov 2018to 19 May 2020
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients who require subclavian venous catheterization
- adult patients aged 20-79
Who cannot join
- patient's refusal
- patients with contraindication of subclavian venous catheterization (skin infection at puncture site, tumor or thrombus in the course of subclavian vein, vegetation at tricuspid valve, patients on anticoagulation)
- patients with chemoport or pacemaker in subclavian vein
- patients with right-sided breast cancer operation or with right-sided pneumonectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Non-inferiority Trial on Complications Related to Ultrasonography-guided Subclavian Venous Catheterization: Supraclavicular Versus Infraclavicular Approach
For performing subclavian venous catheterization, two approaches (supraclavicular and infraclavicular) have been used successfully in various clinical practice. However, there remains controversy concerning which approach is safer and causes less complications during ultrasonography-guided subclavian venous catheterization. In this context, the investigators sought to compare supraclavicular approach with infraclavicular approach in terms of post-procedural complications during ultrasonography-guided subclavian venous catheterization.
- Conditions
- Complication of Treatment, Catheterization
- Being tested
- Supra- vs Infraclavicular approach using ultrasonography
- Keywords
- subclavian venous catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supra- vs Infraclavicular approach using ultrasonographyProcedure or surgery
In the supraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle. Meanwhile, in the infraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle.
| Study group | Role | What they receive |
|---|---|---|
| Infraclavicular group | Active comparator | In the infraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle. Receives: Procedure: Supra- vs Infraclavicular approach using ultrasonography |
| Supraclavicular group | Active comparator | In the supraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle. Receives: Procedure: Supra- vs Infraclavicular approach using ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
the overall incidence of complications
The overall incidence of complications will be expressed as the sum of incidences of complications which occurred during subclavian venous catheterization including arterial puncture, hematoma formation, pneumothorax, hemothorax, and malposition of catheter. Arterial puncture, hematoma formation, and malposition of catheter will be evaluated with ultrasonography, and pneumothorax and hemothorax will be evaluated by chest radiography.
Measured: intraoperatively to 1 hour after the admission of ICU
Secondary outcomes (3)
the first-pass success rate
The first-pass success was defined as successful catheterization on a single attempt in all stages of catheterization.
Measured: intraoperatively
the number of needling for venipuncture
The number of needling for venipuncture was defined as the amount of needling for successful subclavian venous puncture.
Measured: intraoperatively
Total time for venipuncture
Total time for venipuncture was defined as the amount of time which took for successful subclavian venous puncture.
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2018
- Study start27 Nov 2018
- Primary completion19 May 2020
- Study completion19 May 2020
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 Complication of TreatmentStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hee-Pyoung Park, Seoul National University Hospital
- Investigators
- Hee-pyoung Park, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03677765
- Sponsor's protocol ID
- US_SVC: SC vs IC
- Status last verified
- Jun 2020
- First submitted
- 9 Sep 2018
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 34231204
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Non-inferiority Trial on Complications Related to Ultrasonography-guided Subclavian Venous Catheterization: Supraclavicular Versus Infraclavicular Approach
- ClinicalTrials.gov ID
- NCT03677765
- Acronym / sponsor ID
- US_SVC: SC vs IC
- Conditions
- Complication of Treatment, Catheterization
- Keywords
- subclavian venous catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Nov 2018 (actual)
- Primary completion
- 19 May 2020 (actual)
- Study completion
- 19 May 2020 (actual)
- First posted
- 19 Sep 2018 (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.
For performing subclavian venous catheterization, two approaches (supraclavicular and infraclavicular) have been used successfully in various clinical practice. However, there remains controversy concerning which approach is safer and causes less complications during ultrasonography-guided subclavian venous catheterization. In this context, the investigators sought to compare supraclavicular approach with infraclavicular approach in terms of post-procedural complications during ultrasonography-guided subclavian venous catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infraclavicular group | Active comparator | Procedure: Supra- vs Infraclavicular approach using ultrasonographyIn the infraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle. |
| Supraclavicular group | Active comparator | Procedure: Supra- vs Infraclavicular approach using ultrasonographyIn the supraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle. |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients who require subclavian venous catheterization
- adult patients aged 20-79
Key exclusion criteria (4 listed)
- patient's refusal
- patients with contraindication of subclavian venous catheterization (skin infection at puncture site, tumor or thrombus in the course of subclavian vein, vegetation at tricuspid valve, patients on anticoagulation)
- patients with chemoport or pacemaker in subclavian vein
- patients with right-sided breast cancer operation or with right-sided pneumonectomy
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 |
|---|---|---|
| Supra- vs Infraclavicular approach using ultrasonographyIn the supraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle. Meanwhile, in the infraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle. | Procedure or surgery | Infraclavicular group, Supraclavicular group |
Primary outcome
the overall incidence of complications
Time frame: intraoperatively to 1 hour after the admission of ICU
The overall incidence of complications will be expressed as the sum of incidences of complications which occurred during subclavian venous catheterization including arterial puncture, hematoma formation, pneumothorax, hemothorax, and malposition of catheter. Arterial puncture, hematoma formation, and malposition of catheter will be evaluated with ultrasonography, and pneumothorax and hemothorax will be evaluated by chest radiography.
3 secondary outcomes
the first-pass success rate
Time frame: intraoperatively
the number of needling for venipuncture
Time frame: intraoperatively
Total time for venipuncture
Time frame: intraoperatively
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 1 Jul 2020.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
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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.
Hee-pyoung Park, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supra- vs Infraclavicular approach using ultrasonography in people with Complication of Treatment and Catheterization, run by Seoul National University Hospital at 1 site in South Korea.
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 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 1 Jul 2020. 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 South Korea. 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 incidence of complications (time frame: intraoperatively to 1 hour after the admission of ICU). 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 NCT03677765, 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 1 Jul 2020.