A Clinical Trial Evaluating the Effectiveness and Safety of the PowerMe Midline Catheter in the Chinese Population

Study Overview
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Brief Summary
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This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.

Detailed Description
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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.

Official Title
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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

Conditions
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Catheterization

Intervention / Treatment
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* Device: catheter placement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: PowerMe Midline
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Powerme midline catheter<br>Powerme midline catheter | Device: catheter placement<br>* catheter placement<br>|
| Sham Comparator: peripheral intravenous catheter<br>BD Pegusas peripheral intravenous catheter | Device: catheter placement<br>* catheter placement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance of the overall performance of the IV catheter system | After the placement of the IV catheter system, the study nurse shall answer yes/no to the following questions: Can the IV catheter system vent the air properly; Can the IV catheter system be inserted and be placed in the blood vessel; 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: Can the IV catheter system be removed properly; There is no leakage during the application of the IV catheter system (including the processes of venting, infusion, flushing and sealing, and indwelling). | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of the first insertion of the catheter | Successful first insertion means the IV catheter system can be successfully inserted into the blood vessel on the first insertion. | First day, during catheter insertion | 
| Indwelling time | The retention time of the IV catheter system of each subject after successful insertion. | up to 28 days | 
| Rate of good performance of the pinch clamp | If the pinch clamp can close and open the tubing properly, performance of the pinch clamp can be evaluated as good. | up to 28 days | 
| Incidence of catheter blockage | The catheter system is blocked, causing the system to fail to infuse the fluid after it is connected to the infusion set/syringe. | up to 28 days | 
| Incidence of accidental dislodgement | Unintentional premature removal of the catheter from the vessel. | up to 28 days | 
| Incidence of phlebitis | Incidence of phlebitis | up to 28 days | 
| Incidence of adverse events | Incidence of adverse events | up to 28 days | 
| Incidence of serious adverse events | Incidence of serious adverse events | up to 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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midline, overall performance, indwelling time