An interventional study of Intravenous Access Device Flushing in Effectiveness and Safety of Pre-filled Flush Syringe, sponsored by Becton, Dickinson and Company. Completed at 3 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-30.
Sponsored by Becton, Dickinson and Company · Not applicable, Interventional, and Other
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.
Becton, Dickinson and Company is the lead sponsor of 61 studies on the registry; 5 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 8 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
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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.
PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)
Device: Intravenous Access Device Flushing
PosiFlush™ Pre-filled Flush Syringes (BD, USA)
Device: Intravenous Access Device Flushing
locking and flushing the end of catheter line at the intervals of different drug treatment.
the Overall Performance for Flushing and / or Locking the Catheters.
Evaluation method: Overall performance is assessed by a Nurse, who need to answer the following questions: 1. Can air in the BD Pre-filled Flush Syringes be expelled successfully? 2. Can BD Pre-filled Flush Syringes be connected to the catheter smoothly? 3. Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully? 4. Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly? 5. Any leakage observed at any part of the Flush syringe at any time during the usage? Overall performance for flushing and/or locking the catheter is only considered as "success" if: Question 1 to 4 answered with "YES", and question 5 answered with "NO".
Time frame: one hour after treatment
Device Ease of Use
Nurse questionnaire: 1\) Is the plunger easy to push forward when flushing or locking? Score on a 5-point scale: '3' means easy
Time frame: one hour after treatment
Number of Adverse Events and Serious Adverse Events
Number of adverse events, Incidence of serious adverse events
Time frame: 1 hour after treatment
| Milestone | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) |
|---|---|---|
| Started | 189 | 189 |
| Completed | 188 | 187 |
| Not completed | 1 | 2 |
Evaluation method: Overall performance is assessed by a Nurse, who need to answer the following questions: 1. Can air in the BD Pre-filled Flush Syringes be expelled successfully? 2. Can BD Pre-filled Flush Syringes be connected to the catheter smoothly? 3. Can BD Pre-filled Flush Syringes flush and /or lock the catheter successfully? 4. Can BD Pre-filled Flush Syringes disconnect from the catheters smoothly? 5. Any leakage observed at any part of the Flush syringe at any time during the usage? Overall performance for flushing and/or locking the catheter is only considered as "success" if: Question 1 to 4 answered with "YES", and question 5 answered with "NO".
| participants | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) |
|---|---|---|
| the Overall Performance for Flushing and / or Locking the Catheters. | 187 | 185 |
Nurse questionnaire: 1\) Is the plunger easy to push forward when flushing or locking? Score on a 5-point scale: '3' means easy
| participants | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) |
|---|---|---|
| Device Ease of Use | 187 | 185 |
Number of adverse events, Incidence of serious adverse events
| Participants | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) |
|---|---|---|
| Number of Adverse Events and Serious Adverse Events | 1 | 0 |
Collected over The time frame consists of 3 time periods: From screening period (Day-2,-1,0), flush syringe treatment period (Day1) to follow-up period (Day 1, 1 hour after the flush syringe treatment).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | 0/189 (0%) | 0/189 (0%) | 1/189 (0.5%) |
| PosiFlush™ Pre-filled Flush Syringes (BD, USA) | 0/187 (0%) | 0/187 (0%) | 0/187 (0%) |
| Event | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) |
|---|---|---|
| bleeding spotSkin and subcutaneous tissue disorders | 1/189 | 0/187 |
| Age, Continuous(years) | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| Mean | 55.58 ± 17.11 | 56.15 ± 16.87 | 55.86 ± 16.97 |
| Sex: Female, Male(Participants) | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| Female | 82 | 74 | 156 |
| Male | 107 | 115 | 222 |
| Race and Ethnicity Not Collected(Participants) | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| China | 189 | 189 | 378 |
| Temperature(℃) | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| Mean | 36.40 ± 0.27 | 36.42 ± 0.30 | 36.41 ± 0.28 |
| Pulse(beats per minute) | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| Mean | 76.9 ± 10.5 | 77.6 ± 10.8 | 77.3 ± 10.6 |
| respiratory rate(breathes per minute) | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| Mean | 18.1 ± 0.7 | 18.1 ± 0.5 | 18.1 ± 0.6 |
| Systolic blood pressure, SBP(millimeters of mercury (mmHG)) | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| Mean | 122.2 ± 13.3 | 121.3 ± 13.6 | 121.8 ± 13.5 |
1 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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