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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06043895
Other study ID # 202304082DIND
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date December 2024

Study information

Verified date September 2023
Source National Taiwan University Hospital
Contact Man-Ling Wang, MD, PhD
Phone +886-2312-3456
Email mlwang@ntu.edu.tw
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria (for participants): - 18 years old and above - Surgical patients who need to have a central venous catheter placed - Informed and agree to participate in the study Inclusion Criteria (for conducting physicians): - Physicians with >100 central venous catheter placement experience, including attending physicians and senior residents Exclusion Criteria (for participants): - Patient refusal - Puncture site skin lesions - Uncorrected coagulation disorder - Hemodynamic instability - Not informed and consented to participate in research Exclusion Criteria (for conducting physicians): - Not informed and consented to participate in research

Study Design


Intervention

Device:
EpiFaith CV
The conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture.
Conventional
The conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture.

Locations

Country Name City State
Taiwan National Taiwan University Hospital Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 1 hour
Secondary Amount of blood drawn The total amount of blood drawn during the procedure 1 hour
Secondary Number of attempts to place guidewire Number of attempts to place guidewire during the procedure 1 hour
Secondary Arterial puncture rate The rate of arterial puncture during the procedure 1 hour
Secondary Arterial puncture identification rate The rate of identification of arterial puncture 1 hour
Secondary Success rate The rate for successful central venous catheterization within 3 attempts 1 hour
Secondary Likert scale for satisfaction Likert scale for satisfaction of using either device for central venous catheterization and qualitative measurement for user experiences 1 hour
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