EpiFaith CV for Central Venous Catheterization

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Perioperative Care; Patient Safety; Catheterization, Central Venous; Equipment Design; Anesthesiology Devices Associated With Misadventures, Diagnostic and Monitoring Devices
• Intervention / Treatment: Device: EpiFaith CV; Device: Conventional

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Man-Ling Wang, MD, PhD; Phone Number: 262158 +886-2312-3456; Email: mlwang@ntu.edu.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital
    • Contact: Man-Ling Wang, MD, PhD; Phone Number: 262158 +886-2-2312-3456; Email: mlwang@ntu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EpiFaith CV; The conducting physicians in this group will use EpiFaith CV to localize the central vein and assess if there is arterial puncture	Device: EpiFaith CV; The conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture.
Active Comparator: Conventional; The conducting physicians in this group will use Raulerson syringe to localize the central vein and assess if there is arterial puncture	Device: Conventional; The conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Man-Ling Wang, MD, PhD, Department of Anesthesiology, National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: September 12, 2023
• First Submitted That Met QC Criteria: September 12, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 20, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Patient Safety; Anesthesiology; Central Venous Catheterization; Visual Feedback; Clinical Skill
• Other Study ID Numbers: 202304082DIND

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: There is a plan to make IPD and related data dictionaries available.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: The PI will review requests
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No