Catheterization, Central VenousNCT06043895
EpiFaith CV for Central Venous Catheterization
A study testing EpiFaith CV and Conventional in people with Catheterization, Central Venous and Equipment Design, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
EpiFaith CV provides automatic aspiration and detection of arterial pressure as an alternative to manometry in central venous catheterization. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Catheterization, Central Venous, Equipment Design, Patient Safety
- What is being tested?
- EpiFaith CV and Conventional
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2023to 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years old and above
- Surgical patients who need to have a central venous catheter placed
- Informed and agree to participate in the study
- Physicians with >100 central venous catheter placement experience, including attending physicians and senior residents
Who cannot join
- Patient refusal
- Puncture site skin lesions
- Uncorrected coagulation disorder
- Hemodynamic instability
- Not informed and consented to participate in research
- Not informed and consented to participate in research
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 100
Man-Ling Wang, MD, PhD, +886-2-2312-3456 ext. 262158, mlwang@ntu.edu.tw
About this study
Official title: The Overall Surgical Time Comparison Between EpiFaith® CV and Conventional Syringe in Central Venous Catheterization
EpiFaith CV provides automatic aspiration and detection of arterial pressure as an alternative to manometry in central venous catheterization. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.
Read the detailed description
Central venous catheterization (CVC) is crucial in modern perioperative and intensive care. Keeping constant and stable negative pressure while advancing the needle had been issue for beginners. Recently, EpiFaith CV provides a new solution for CVC, which facilitates syringe control and precision during assessing vessels. It provides steady aspiration and detection of arterial pressure as an alternative to manometry without the need to disconnect nor more connections. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.
- Conditions
- Catheterization, Central Venous, Equipment Design, Patient Safety, Anesthesiology Devices Associated With Misadventures, Diagnostic and Monitoring Devices, Perioperative Care
- Being tested
- EpiFaith CV, Conventional
- Keywords
- Central Venous Catheterization, Patient Safety, Visual Feedback, Anesthesiology, Clinical Skill
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpiFaith CVDevice
The conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture.
ConventionalDevice
The conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture.
| Study group | Role | What they receive |
|---|---|---|
| EpiFaith CV | Experimental | The conducting physicians in this group will use EpiFaith CV to localize the central vein and assess if there is arterial puncture Receives: Device: EpiFaith CV |
| Conventional | Active comparator | The conducting physicians in this group will use Raulerson syringe to localize the central vein and assess if there is arterial puncture Receives: Device: Conventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall surgical time
The time from needle insertion, aspiration of blood, assessment of vein or artery, insertion of guidewire, until removal of the needle
Measured: 1 hour
Secondary outcomes (6)
Amount of blood drawn
The total amount of blood drawn during the procedure
Measured: 1 hour
Number of attempts to place guidewire
Number of attempts to place guidewire during the procedure
Measured: 1 hour
Arterial puncture rate
The rate of arterial puncture during the procedure
Measured: 1 hour
Arterial puncture identification rate
The rate of identification of arterial puncture
Measured: 1 hour
Success rate
The rate for successful central venous catheterization within 3 attempts
Measured: 1 hour
Likert scale for satisfaction
Likert scale for satisfaction of using either device for central venous catheterization and qualitative measurement for user experiences
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheterization, Central VenousStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Man-Ling Wang, MD, PhD, Principal investigator, Department of Anesthesiology, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06043895
- Sponsor's protocol ID
- 202304082DIND
- Status last verified
- Sep 2023
- First submitted
- 12 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Overall Surgical Time Comparison Between EpiFaith® CV and Conventional Syringe in Central Venous Catheterization
- ClinicalTrials.gov ID
- NCT06043895
- Acronym / sponsor ID
- 202304082DIND
- Conditions
- Catheterization, Central Venous, Equipment Design, Patient Safety, Anesthesiology Devices Associated With Misadventures, Diagnostic and Monitoring Devices, Perioperative Care
- Keywords
- Central Venous Catheterization, Patient Safety, Visual Feedback, Anesthesiology, Clinical Skill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 21 Sep 2023 (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.
EpiFaith CV provides automatic aspiration and detection of arterial pressure as an alternative to manometry in central venous catheterization. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.
Detailed description
Central venous catheterization (CVC) is crucial in modern perioperative and intensive care. Keeping constant and stable negative pressure while advancing the needle had been issue for beginners. Recently, EpiFaith CV provides a new solution for CVC, which facilitates syringe control and precision during assessing vessels. It provides steady aspiration and detection of arterial pressure as an alternative to manometry without the need to disconnect nor more connections. The aim of the study is to evaluate if it may reduce operation time compared with conventional syringe.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EpiFaith CV | Experimental | Device: EpiFaith CVThe conducting physicians in this group will use EpiFaith CV to localize the central vein and assess if there is arterial puncture |
| Conventional | Active comparator | Device: ConventionalThe conducting physicians in this group will use Raulerson syringe to localize the central vein and assess if there is arterial puncture |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old and above
- Surgical patients who need to have a central venous catheter placed
- Informed and agree to participate in the study
- Physicians with >100 central venous catheter placement experience, including attending physicians and senior residents
Key exclusion criteria (6 listed)
- Patient refusal
- Puncture site skin lesions
- Uncorrected coagulation disorder
- Hemodynamic instability
- Not informed and consented to participate in research
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 |
|---|---|---|
| EpiFaith CVThe conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture. | Device | EpiFaith CV |
| ConventionalThe conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture. | Device | Conventional |
Primary outcome
The overall surgical time
Time frame: 1 hour
The time from needle insertion, aspiration of blood, assessment of vein or artery, insertion of guidewire, until removal of the needle
6 secondary outcomes
Amount of blood drawn
Time frame: 1 hour
Number of attempts to place guidewire
Time frame: 1 hour
Arterial puncture rate
Time frame: 1 hour
Arterial puncture identification rate
Time frame: 1 hour
Success rate
Time frame: 1 hour
Likert scale for satisfaction
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2023.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available.
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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.
Man-Ling Wang, MD, PhD principal investigator
Department of Anesthesiology, National Taiwan 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 EpiFaith CV and Conventional in people with Catheterization, Central Venous and Equipment Design, run by National Taiwan University Hospital at 1 site in Taiwan.
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 4 inclusion and 6 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 22 Sep 2023. 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 Taiwan. 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 Man-Ling Wang, MD, PhD (+886-2312-3456 ext. 262158, mlwang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall surgical time (time frame: 1 hour). 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 22 Sep 2023.