Effectiveness and Safety of Pre-filled Flush Syringe
Conditions
Brief summary
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.
Interventions
DEVICEIntravenous Access Device Flushing
locking and flushing the end of catheter line at the intervals of different drug treatment.
Sponsors
Becton, Dickinson and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the Overall Performance for Flushing and / or Locking the Catheters. | one hour after treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Ease of Use | one hour after treatment | Nurse questionnaire: 1\) Is the plunger easy to push forward when flushing or locking? Score on a 5-point scale: '3' means easy |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events and Serious Adverse Events | 1 hour after treatment | Number of adverse events, Incidence of serious adverse events |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)
Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment. | 189 |
| PosiFlush™ Pre-filled Flush Syringes (BD, USA) PosiFlush™ Pre-filled Flush Syringes (BD, USA)
Intravenous Access Device Flushing: locking and flushing the end of catheter line at the intervals of different drug treatment. | 189 |
| Total | 378 |
Baseline characteristics
| Characteristic | PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Total |
|---|---|---|---|
| Age, Continuous | 55.58 years STANDARD_DEVIATION 17.11 | 56.15 years STANDARD_DEVIATION 16.87 | 55.86 years STANDARD_DEVIATION 16.97 |
| Diastolic blood pressure, DBP | 75.0 millimeters of mercury (mmHG) STANDARD_DEVIATION 8.5 | 74.9 millimeters of mercury (mmHG) STANDARD_DEVIATION 8.9 | 74.9 millimeters of mercury (mmHG) STANDARD_DEVIATION 8.7 |
| Pulse | 76.9 beats per minute STANDARD_DEVIATION 10.5 | 77.6 beats per minute STANDARD_DEVIATION 10.8 | 77.3 beats per minute STANDARD_DEVIATION 10.6 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 189 participants | 189 participants | 378 participants |
| respiratory rate | 18.1 breathes per minute STANDARD_DEVIATION 0.7 | 18.1 breathes per minute STANDARD_DEVIATION 0.5 | 18.1 breathes per minute STANDARD_DEVIATION 0.6 |
| Sex: Female, Male Female | 82 Participants | 74 Participants | 156 Participants |
| Sex: Female, Male Male | 107 Participants | 115 Participants | 222 Participants |
| Systolic blood pressure, SBP | 122.2 millimeters of mercury (mmHG) STANDARD_DEVIATION 13.3 | 121.3 millimeters of mercury (mmHG) STANDARD_DEVIATION 13.6 | 121.8 millimeters of mercury (mmHG) STANDARD_DEVIATION 13.5 |
| Temperature | 36.40 ℃ STANDARD_DEVIATION 0.27 | 36.42 ℃ STANDARD_DEVIATION 0.3 | 36.41 ℃ STANDARD_DEVIATION 0.28 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 189 | 0 / 187 |
| other Total, other adverse events | 1 / 189 | 0 / 187 |
| serious Total, serious adverse events | 0 / 189 | 0 / 187 |
Outcome results
Primary
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
Population: Number of nurses who is 'success' per the evaluation method~For study group, 1 patient withdrew the study and primary endpoint result was not obtained, the other patient met exclusion criteria 4. For control group, 1 patient withdrew the study and primary endpoint result was not obtained, 2 patient met exclusion criteria 4, and the other 1 patient didn't meet inclusion criteria 4. The 6 patients were not included in PPS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | the Overall Performance for Flushing and / or Locking the Catheters. | 187 participants |
| PosiFlush™ Pre-filled Flush Syringes (BD, USA) | the Overall Performance for Flushing and / or Locking the Catheters. | 185 participants |
Secondary
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
Population: number of nurses who gives '\> 3 easy'~For study group, 1 patient withdrew the study and primary endpoint result was not obtained, the other patient met exclusion criteria 4. For control group, 1 patient withdrew the study and primary endpoint result was not obtained, 2 patient met exclusion criteria 4, and the other 1 patient didn't meet inclusion criteria 4. The 6 patients were not included in PPS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | Device Ease of Use | 187 participants |
| PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Device Ease of Use | 185 participants |
Other Pre-specified
Number of Adverse Events and Serious Adverse Events
Number of adverse events, Incidence of serious adverse events
Time frame: 1 hour after treatment
Population: For control group, 2 patients didn't use the study devices and were not included in safety set.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PosiFlush™ Pre-filled Flush Syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.) | Number of Adverse Events and Serious Adverse Events | 1 Participants |
| PosiFlush™ Pre-filled Flush Syringes (BD, USA) | Number of Adverse Events and Serious Adverse Events | 0 Participants |