Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiFaith CV | Device | The conducting physician will localize the central vein using EpiFaith CV and assess if there is arterial puncture. |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria (for participants):
Inclusion Criteria (for conducting physicians):
Exclusion Criteria (for participants):
Exclusion Criteria (for conducting physicians):
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Man-Ling Wang, MD, PhD | Contact | +886-2312-3456 | 262158 | mlwang@ntu.edu.tw |
| Name | Affiliation | Role |
|---|---|---|
| Man-Ling Wang, MD, PhD | Department of Anesthesiology, National Taiwan University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwan University Hospital | Taipei | 100 | Taiwan |
There is a plan to make IPD and related data dictionaries available.
Starting 6 months after publication
The PI will review requests
Not provided
Not provided
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| Conventional | Device | The conducting physician will localize the central vein using Raulerson syringe and assess if there is arterial puncture. |
|
| 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 |