Study of BD Pre-filled Flush Syringes in China

Study Overview
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Brief Summary
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This study is to compare the BD PosiFlush™ Pre-filled Flush Syringes (manufactured by BD, USA) and evaluate the effectiveness and safety of the pre-filled flush syringes (manufactured by Suzhou Becton Dickinson Medical Devices Co., Ltd.) for locking and flushing the end of catheter line in Chinese popluation.

Official Title
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A Prospective, Multi-center, Randomized, Open Label, Controlled Trial of BD Pre-filled Flush Syringes

Conditions
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Effectiveness and Safety of Pre-filled Flush Syringe

Intervention / Treatment
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* Device: Intravenous Access Device Flushing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Age >or equal to 18, no limitation on gender; 2. Hospitalized patients; 3. Patients who are anticipated to need or have in situ vascular access catheter devices (This may include: Peripheral Intravenous Catheter (PIVC), Central Venous Catheter (such as peripherally inserted central catheter (PICC)); 4. Patients who are expected to require flushing the vascular access catheter with saline at the beginning, during, or end of infusion therapy, or who require to flush and/or lock vascular access catheters at the beginning, during, the end of drug therapy; 5. Patients who can understand the purpose of the trial, agree to participate in this clinical trial and voluntarily sign the informed consent form. Exclusion Criteria: 1. Patient reports pregnancy or lactation (self-report); 2. Subjects who are known to have blockage or recanalization of vascular access prior to this trial. 3. Subjects who are known to have uncomfortable symptoms such as redness and pain, or common complication associated with indwelling catheter such as phlebitis and infection at the localized insertion site prior to this trial. 4. Patient participating in another drug or medical device clinical trial at the time of consent or has participated in a drug or medical device clinical trial within three months before enrollment; 5. Any other situation that, in the option of the Investigator would make the patient considered unfit for this study.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)<br>PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | Device: Intravenous Access Device Flushing<br>* locking and flushing the end of catheter line at the intervals of different drug treatment.<br>|
| Active Comparator: PosiFlush™ Pre-filled Flush Syringes (BD, USA)<br>PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Device: Intravenous Access Device Flushing<br>* locking and flushing the end of catheter line at the intervals of different drug treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the overall performance for flushing and / or locking the catheters. | Composite score using a 5-question nurse survey: Can air in the BD Pre-filled Flush Syringes be expelled successfully? Can BD Pre-filled Flush Syringes connected to the catheter smoothly? Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully? Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly? Any leakage observed at any part of the Flush syringe at any time during the usage? Overall performance for locking and flushing the catheter deemed as success if Question 1 to 4 answered with YES, and question 5 answered with NO. | immediately after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device ease of use | Nurse questionnaire: 1) Is the plunger easy to push forward when flushing or locking? | immediately after treatment |