EpiFaith CV for Central Venous Catheterization

NCT ID: NCT06043895

Last Updated: 2023-09-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2024-12-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

EpiFaith CV

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

Group Type: EXPERIMENTAL

EpiFaith CV

Intervention Type: DEVICE

The conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture.

Conventional

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

Group Type: ACTIVE_COMPARATOR

Conventional

Intervention Type: DEVICE

The conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture.

Interventions

EpiFaith CV

The conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture.

Intervention Type: DEVICE

Conventional

The conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 years old and above
• Surgical patients who need to have a central venous catheter placed
• Informed and agree to participate in the study

• Physicians with >100 central venous catheter placement experience, including attending physicians and senior residents

Exclusion Criteria

• Patient refusal
• Puncture site skin lesions
• Uncorrected coagulation disorder
• Hemodynamic instability
• Not informed and consented to participate in research

• Not informed and consented to participate in research

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Man-Ling Wang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

Central Contacts

Man-Ling Wang, MD, PhD

Role: CONTACT

mlwang@ntu.edu.tw

+886-2312-3456 ext. 262158

Facility Contacts

Man-Ling Wang, MD, PhD

Role: primary

mlwang@ntu.edu.tw

+886-2-2312-3456 ext. 262158

Other Identifiers

202304082DIND

Identifier Type: -

Identifier Source: org_study_id