A Prospective, Multi-center, Open-label, Randomized, Controlled Non-inferiority Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter Versus Traditional PIV in the Chinese Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 256
- Locations
- 4
- Primary Endpoint
- Acceptance of the overall performance of the IV catheter system
Study Overview
Brief Summary
This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.
Detailed Description
This is a prospective, multi-center, open-label, randomized, controlled, non-inferiority clinical trial designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter compared to PIVC in the Chinese population in order to support the product's registration in China.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥18 years of age;
- •Inpatient with a need for intravenous infusion for an expected period of more than 4 days but no more than 28 days;
- •The veins in the upper limbs is suitable for puncture and catheterization of both the investigational device and the control device;
- •Willing to provide written Informed Consent and complete the study per the protocol.
Exclusion Criteria
- •Coagulation disorder or active bleeding;
- •Skin injury, infection, or dermatosis at the site to be punctured;
- •History of radiotherapy, thrombosis, or vascular surgery; arteriovenous fistula or phlebitis history at the area and/or vein to be catheterized;
- •History of mental illness;
- •End stage renal disease requires vein protection;
- •Conditions with decreased venous flow in the extremity, such as lymphedema of the arm, etc.;
- •Infusions of vesicant or irritant drugs, hyperosmotic infusate (the osmotic pressure >900mOsm/L in this study), parenteral nutrition, etc., which are not suitable for peripheral intravenous infusion (If other appropriate venous access is established for the aforementioned infusates, the patient may be enrolled).
- •The evaluation of the upper limb veins is Grade II, the evaluation grade is as following:
- •0 Veins are obviously bulged on the skin surface. The veins are touchable, thick, straight, soft, elastic and fixed.
- •I Veins are relatively full and faintly touchable. The veins are less elastic or slide easily.
- •II Veins are not full or collapsed and untouchable. The veins are hard or sliding. Phlebitis.
- •Self-reported being pregnant or lactating;
- •Other conditions that the investigator considers improper for the study;
- •Participating in another study or already enrolled.
Arms & Interventions
Powerme midline catheter
Powerme midline catheter
Intervention: catheter placement (Device)
peripheral intravenous catheter
BD Pegusas peripheral intravenous catheter
Intervention: catheter placement (Device)
Outcomes
Primary Outcomes
Acceptance of the overall performance of the IV catheter system
Time Frame: up to 28 days
After the placement of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 1. Can the IV catheter system vent the air properly; 2. Can the IV catheter system be inserted and be placed in the blood vessel; 3. Can the needle tube be withdrawn from the septum; After the removal of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 4. Can the IV catheter system be removed properly; 5. There is no leakage during the application of the IV catheter system (including the processes of venting, infusion, flushing and sealing, and indwelling).
Secondary Outcomes
- Incidence of adverse events(up to 28 days)
- Incidence of phlebitis(up to 28 days)
- Success rate of the first insertion of the catheter(First day, during catheter insertion)
- Indwelling time(up to 28 days)
- Rate of good performance of the pinch clamp(up to 28 days)
- Incidence of catheter blockage(up to 28 days)
- Incidence of accidental dislodgement(up to 28 days)
- Incidence of serious adverse events(up to 28 days)