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Completed

NCT Number: NCT05763147

Study of BD Pre-filled Flush Syringes in China

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Friendship Hospital, Beijing, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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.
  • 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.

Treatment and study plan

Intravenous Access Device Flushing

Device

locking and flushing the end of catheter line at the intervals of different drug treatment.

Primary outcomes

  1. the Overall Performance for Flushing and / or Locking the Catheters.

    Time frame: one hour after treatment

    Evaluation method:

    Overall performance is assessed by a Nurse, who need to answer the following questions:

    • Can air in the BD Pre-filled Flush Syringes be expelled successfully?
    • Can BD Pre-filled Flush Syringes be 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 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 outcomes

  1. Device Ease of Use

    Time frame: one hour after treatment

    Nurse questionnaire:

    • Is the plunger easy to push forward when flushing or locking? Score on a 5-point scale: '3' means easy

Other outcomes

  1. Number of Adverse Events and Serious Adverse Events

    Time frame: 1 hour after treatment

    Number of adverse events, Incidence of serious adverse events

Sponsors and collaborators

Lead sponsor

Becton, Dickinson and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.