EpiFaith CV for Central Venous Catheterization

Not Applicable

Not yet recruiting

• Conditions: Equipment Design; Patient Safety; Anesthesiology Devices Associated With Misadventures, Diagnostic and Monitoring Devices; Catheterization, Central Venous; Perioperative Care
• Interventions: Device: EpiFaith CV; Device: Conventional

• Registration Number: NCT06043895
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

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 Timeline

• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EpiFaith CV	EpiFaith CV	The conducting physicians in this group will use EpiFaith CV to localize the central vein and assess if there is arterial puncture
Conventional	Conventional	The conducting physicians in this group will use Raulerson syringe to localize the central vein and assess if there is arterial puncture

Primary Outcome Measures

Name	Time	Method
The overall surgical time	1 hour	The time from needle insertion, aspiration of blood, assessment of vein or artery, insertion of guidewire, until removal of the needle

Secondary Outcome Measures

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

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan