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

Recruitment & Eligibility

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.

Study & Design

Arm && Interventions

Group	Intervention	Description
Powerme midline catheter	catheter placement	Powerme midline catheter
peripheral intravenous catheter	catheter placement	BD Pegusas peripheral intravenous catheter

Primary Outcome Measures

Name	Time	Method
Acceptance of the overall performance of the IV catheter system	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 Can the needle tube be withdrawn from the septum; After the removal of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 4.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 Outcome Measures

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

Recruitment & Eligibility