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

NCT04719377 | Completed

• 1 other identifier: CDC-19POWME01
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Catheterization

Keywords

midline; overall performance; indwelling time

Outcome Measures

Primary Outcomes (1)

• 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 Can the needle tube be withdrawn from the septum; After the removal of the IV catheter system, the study nurse shall answer "yes/no" to the following questions: 4.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).

  up to 28 days

Secondary Outcomes (8)

• 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

Study Arms (2)

Powerme midline catheter

EXPERIMENTAL

Powerme midline catheter

Device: catheter placement

peripheral intravenous catheter

SHAM COMPARATOR

BD Pegusas peripheral intravenous catheter

Device: catheter placement

Interventions

catheter placement DEVICE

catheter placement

Powerme midline catheter; peripheral intravenous catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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:
• 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.

Sponsors & Collaborators

• Becton, Dickinson and Company: lead

Study Sites (4)

Hunan Cancer Hospital

Changsha, China

Location

Shanghai First General Hospital

Shanghai, 200040, China

Location

Shanghai Ninth People's Hospital

Shanghai, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, China

Location

Study Officials

• Xuying Li, RN

  Hunan Cancer Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: PowerMe Midline

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: January 22, 2021
• Study Start: January 13, 2021
• Primary Completion: January 30, 2022
• Study Completion: January 30, 2022
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)