EpiFaith CV for Central Venous Catheterization

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Device: EpiFaith CV
* Device: Conventional


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central Venous Catheterization, Patient Safety, Visual Feedback, Anesthesiology, Clinical Skill