Safety and Effectiveness of CATHTONG™ II PICC

NCT03841955 | Completed

• 1 other identifier: PICC-2017-1016
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 4

Brief Summary

This clinical trial is a prospective, multi-centre, open, parallel and comparative non-inferior trial design.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Successful rate of one-time catheterization

  Subcutaneous detection of blood vessel movements less than three times, and finally completed catheterization and confirmed that the end of the catheter in the pre-positioning proportion of the total number of patients (catheterization success refers to the chest X-ray and other fluoroscopy means to confirm that the end of the catheter is located in the middle and lower segment of superior vena cava).

  Day 1

Secondary Outcomes (3)

• Operating time

  Day 1

• success rate of one puncture.

  Day 1

• The incidence of adverse events

  about three months

Study Arms (2)

Experimental group

EXPERIMENTAL

Peripheral implantation of central venous catheters and accessories with high pressure tolerance

Device: PICC with high pressure tolerance

Control group

EXPERIMENTAL

Peripheral intubation of central venous catheter

Device: rontine central venous catheter

Interventions

PICC with high pressure tolerance DEVICE

Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the experimental group and given the intervention.

Also known as: Peripheral intubation of central venous catheter

Experimental group

rontine central venous catheter DEVICE

Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the control group and given the intervention.

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects volunteered to participate in the trial and signed the informed consent.
• Age 18 years old, 80 years old; gender is not limited;
• Suitable for patients who need central venous catheterization via peripheral venipuncture (life expectancy is more than 6 months): need medium-term and long-term infusion or intravenous drug therapy; need multi-chamber infusion of multiple drugs at the same time; need infusion of irritating, corrosive or hyperosmotic drugs; hyperbaric angiography or central venous pressure monitoring function;
• Patients who need to be maintained in the investigator's hospital after PICC catheterization;
• Ability to communicate well with researchers and comply with test requirements.

You may not qualify if:

• Local infection of puncture vein or occlusion or serious lesion of blood vessel at puncture place;
• Patients with known or suspected allergies to polyurethane;
• Pre-intubation site includes trauma history, vascular surgery history, thrombosis history, radiotherapy history, bilateral breast cancer surgery affected upper limbs, superior vena cava compression syndrome, etc.
• The prothrombin time was 6 seconds longer than the normal value and the activated partial thromboplastin time was 2.5 times longer than the normal value.
• Pregnancy and lactation women;
• The subjects had a history of difficulty in catheterization.
• Patients with pacemaker implantation in vivo;
• Researchers do not consider it appropriate to participate in this clinical trial.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (4)

Affiliated Cancer Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

Sir Run Run Shaw Hospital

Hangzhou, Zhejiang, 310000, China

Location

Zhejiang Provincial Tongde Hospital

Hangzhou, Zhejiang, 310000, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Catheterization, Peripheral

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Jin jingfen, Master

  The second affiliated hosital of medical college of zhejiang university

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: February 15, 2019
• Study Start: October 17, 2018
• Primary Completion: September 20, 2019
• Study Completion: October 30, 2020
• Last Updated: June 16, 2021

Record last verified: 2020-06

Locations

CN (4)