This study is designed to evaluate the effectiveness and the safety of the PowerMeTM Midline Catheter in the Chinese population.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
256
catheter placement
Hunan Cancer Hospital
Changsha, China
Shanghai First General Hospital
Shanghai, China
Shanghai Ninth People's Hospital
Shanghai, China
The First Affiliated Hospital of Soochow University
Suzhou, China
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: 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 Can the needle tube be withdrawn from the septum; After the removal of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 4.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).
Time frame: up to 28 days
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.
Time frame: First day, during catheter insertion
Indwelling time
The retention time of the IV catheter system of each subject after successful insertion.
Time frame: 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".
Time frame: 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.
Time frame: up to 28 days
Incidence of accidental dislodgement
Unintentional premature removal of the catheter from the vessel.
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Time frame: up to 28 days
Incidence of phlebitis
Incidence of phlebitis
Time frame: up to 28 days
Incidence of adverse events
Incidence of adverse events
Time frame: up to 28 days
Incidence of serious adverse events
Incidence of serious adverse events
Time frame: up to 28 days