NCT05555160

Brief Summary

This study was a prospective, multicenter, randomized controlled study. The study aimed to exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on the positioning accuracy of catheter tip and exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on catheterization complications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,051

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2021

Completed
1 year until next milestone

First Posted

Study publicly available on registry

September 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

September 30, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 26, 2022

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

September 22, 2021

Last Update Submit

September 22, 2022

Conditions

Patients Requiring Peripherally Inserted Central Venous Catheters

Outcome Measures

Primary Outcomes (1)

  • Accuracy of tip determination

    IC-ECG method was used to place the tube, and X-ray was used to determine the accuracy of tip location after confirmation. If the two judgments are inconsistent, the third method, such as echocardiography, shall be used. The tip determination accuracy of IC-ECG localization method and X-ray localization method were calculated respectively.X-ray judgment standard: the reference standard is the first choice of the cardiac shadow method: not exceeding the highest protrusion on the left side of the cardiac shadow (tracheal protrusion method: 0-3cm below the tracheal protrusion); Secondary rib reading method: posterior 5-7 ribs.

    Immediately after surgery

Secondary Outcomes (6)

  • incidence of PICC-related complications

    After the operation to 180 days

  • success rate of one catheterization

    Immediately after surgery

  • rate of convenient

    Immediately after surgery

  • rate of unplanned extubation

    After the operation to 180 days

  • Retention duration

    After the operation to 180 days

  • +1 more secondary outcomes

Study Arms (2)

Single-chamber valve tip conductive PICC catheter

EXPERIMENTAL
Device: PICC

Single - chamber valve non - tip conductive PICC catheter

EXPERIMENTAL
Device: PICC

Interventions

PICCDEVICE

Peripheral central venous catheterization (PICC) is mainly applied to patients with medium and long-term intravenous infusion, infusion of stimulant drugs and intermittent infusion of chemotherapy drugs. It is a catheterization technology to place PICC through peripheral veins and make its tip reach the central vein

Single - chamber valve non - tip conductive PICC catheterSingle-chamber valve tip conductive PICC catheter

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥18 years old who need PICC catheterization for the first time according to the doctor's advice;
  • No serious cardiovascular diseases before catheterization, such as atrial fibrillation, pulmonary heart disease and other P wave abnormalities, serious heart block, etc.;
  • patients who did not participate in other clinical studies;
  • Patients who voluntarily participated in the clinical study, signed informed consent and cooperated with clinical follow-up

You may not qualify if:

  • patients with local malformation or scar formation;
  • Patients with infection or damage at the puncture site;
  • patients with tumor compression of blood vessels;
  • Patients with confirmed or suspected catheter-related infection, bacteremia and septicemia
  • Patients diagnosed or suspected to be allergic to silicone material
  • Patients with a history of radiotherapy at the pre-intubation site
  • Patients with a history of venous thrombosis, trauma or vascular surgery
  • Patients with superior vena cava syndrome
  • Patients with poor medical behavior
  • Patients with severe peripheral vascular edema
  • High-flow fluid infusion, patients requiring hemodialysis, pacemaker installation, crutches, or patients who may undergo A-V fistula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2021

First Posted

September 26, 2022

Study Start

September 30, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 26, 2022

Record last verified: 2021-09