EpiFaith CV for Central Venous Catheterization

NCT06043895 | Unknown DMC

• 1 other identifier: 202304082DIND
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Central Venous Catheterization; Patient Safety; Visual Feedback; Anesthesiology; Clinical Skill

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Amount of blood drawn

  1 hour

• Number of attempts to place guidewire

  1 hour

• Arterial puncture rate

  1 hour

• Arterial puncture identification rate

  1 hour

• Success rate

  1 hour

Study Arms (2)

EpiFaith CV

EXPERIMENTAL

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

Conventional

ACTIVE COMPARATOR

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

Device: Conventional

Interventions

EpiFaith CV DEVICE

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

EpiFaith CV

Conventional DEVICE

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

Conventional

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Man-Ling Wang, MD, PhD

  Department of Anesthesiology, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Man-Ling Wang, MD, PhD

CONTACT

+886-2312-3456; mlwang@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The care providers (conducting physicians) and the research assistants who observe and record the results will know the assignments, while the participants and data analysts will not know the assignments.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2023
• First Posted: September 21, 2023
• Study Start: September 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting 6 months after publication
• Access Criteria: The PI will review requests

Locations

TW (1)