EpiFaith CV for Central Venous Catheterization

Patient Safety Clinical Trial

Official title:

The Overall Surgical Time Comparison Between EpiFaith® CV and Conventional Syringe in Central Venous Catheterization

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06043895
• Other study ID #: 202304082DIND
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Catheterization, Central Venous
• Patient Safety
• Perioperative Care

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