EpiFaith CV for Central Venous Catheterization

National Taiwan University

Status: Not yet enrolling

Conditions: Patient Safety; Perioperative Care; Equipment Design; Catheterization, Central Venous; Anesthesiology Devices Associated With Misadventures, Diagnostic and Monitoring Devices

Treatments: Device: EpiFaith CV; Device: Conventional

Study type: Interventional

Funder types: Other

Identifiers

NCT06043895

202304082DIND

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

EpiFaith CV

Experimental group

Description:

The conducting physicians in this group will use EpiFaith CV to localize the central vein and assess if there is arterial puncture

Treatment:

Device: EpiFaith CV

Conventional

Active Comparator group

Description:

The conducting physicians in this group will use Raulerson syringe to localize the central vein and assess if there is arterial puncture

Treatment:

Device: Conventional