The Effect of Skin Laxity on the PICC

NCT05629195 | Unknown

• 1 other identifier: foshan202271
• Study Type: interventional
• Target: 356
• Locations: 0 countries
• Sites: N/A

Brief Summary

To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients (tunneled PICC vs conventional PICC).

Conditions

Complications; Catheter

Outcome Measures

Primary Outcomes (1)

• rate of PICC complications

  Including bleeding, subcutaneous congestion, lymphatic exudation, phlebitis (mechanical phlebitis, thrombophlebitis), infection (local infection, tunnel infection, catheter related blood flow infection), thrombus (symptomatic thrombus, asymptomatic thrombus), catheter ectopic, medical adhesive related skin damage, catheter damage and blockage, etc

  120 days

Secondary Outcomes (5)

• time of PICC insertion

  1 hour

• Success rate of catheterization

  1 hour

• score of operation pain

  1 hour

• rate of unplanned extubation

  120 days

• rate of difficulty in decannulation

  120 days

Study Arms (2)

tunneled PICC

EXPERIMENTAL

Placement of PICC catheter through tunnel technology

Device: tunneled PICC

conventional PICC

ACTIVE COMPARATOR

Placement of PICC catheter through conventional technology

Device: tunneled PICC

Interventions

tunneled PICC DEVICE

PICC catheter is inserted into the superior vena cava through the upper brachial vein by establishing a subcutaneous tunnel

conventional PICC; tunneled PICC

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 18 years old;
• Patients who need PICC catheterization according to the doctor's advice;
• There is no history of venous thrombosis, compression or blockage of superior vena cava, severe coagulation dysfunction and other contraindications for PICC catheterization;
• There is no serious cardiovascular disease, such as atrial fibrillation, pulmonary heart disease and other patients with abnormal P wave, and severe heart block before catheterization
• Patients who have not participated in other clinical studies;
• Patients who voluntarily participate in this clinical study and can cooperate with clinical follow-up

You may not qualify if:

• Known allergy to catheter material;
• The puncture site has a history of infection, injury and radiotherapy;
• The puncture site has a history of venous thrombosis or surgery;
• Severe abnormal bleeding and coagulation function;
• Superior vena cava compression syndrome;
• Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;
• The ipsilateral limb of the pacemaker and the arteriovenous fistula;
• patient or her/his family members refuse to sign the informed consent form.

Sponsors & Collaborators

• First People's Hospital of Foshan: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nurse

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: December 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: December 30, 2023
• Last Updated: November 29, 2022

Record last verified: 2022-11