Study of BD Pre-filled Flush Syringes in China

Not Applicable

Completed

• Conditions: Effectiveness and Safety of Pre-filled Flush Syringe
• Interventions: Device: Intravenous Access Device Flushing

• Registration Number: NCT05763147
• Lead Sponsor: Becton, Dickinson and Company

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-03
• Study First Submitted: 2023-02-28
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-10
• Status Verified: 2023-07
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-26
• Results First Submitted: 2024-05-06
• Results First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Results First Posted: 2024-07-30
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 378

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.

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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.

  2. 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.

  3. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)	Intravenous Access Device Flushing	PosiFlush™ Pre-filled flush syringes (Suzhou Becton Dickinson Medical Devices Co., Ltd.)
PosiFlush™ Pre-filled Flush Syringes (BD, USA)	Intravenous Access Device Flushing	PosiFlush™ Pre-filled Flush Syringes (BD, USA)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Beijing Hospital; 🇨🇳 Beijing, China

Beijing Friendship Hospital; 🇨🇳 Beijing, China

Beijing Jishuitan Hospital; 🇨🇳 Beijing, China