Anesthesiology Devices Associated With Misadventures, Diagnostic and Monitoring Devices, Catheterization, Central Venous, Equipment Design, Patient Safety, Perioperative Care
Conditions
Keywords
Central Venous Catheterization, Patient Safety, Visual Feedback, Anesthesiology, Clinical Skill
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.
Interventions
DEVICEEpiFaith CV
The conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture.
DEVICEConventional
The conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture.
Sponsors
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The overall surgical time | 1 hour | The time from needle insertion, aspiration of blood, assessment of vein or artery, insertion of guidewire, until removal of the needle |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attempts to place guidewire | 1 hour | Number of attempts to place guidewire during the procedure |
| Arterial puncture rate | 1 hour | The rate of arterial puncture during the procedure |
| Amount of blood drawn | 1 hour | The total amount of blood drawn during the procedure |
| Success rate | 1 hour | The rate for successful central venous catheterization within 3 attempts |
| Likert scale for satisfaction | 1 hour | Likert scale for satisfaction of using either device for central venous catheterization and qualitative measurement for user experiences |
| Arterial puncture identification rate | 1 hour | The rate of identification of arterial puncture |
Countries
Taiwan
Contacts
Primary ContactMan-Ling Wang, MD, PhD
Outcome results
None listed