The Effect of Skin Laxity on the PICC (PICC)

Study on the Influence of Skin Laxity on the Application Effect of Different PICC Catheterization Methods

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Complications; Catheter
• Intervention / Treatment: Device: tunneled PICC

Detailed Description

In this study, tunneled PICC was compared with conventional PICC. Eligible subjects were randomly enrolled into the test group or control group by randomization (1:1), and observed and evaluated the occurrence of complications during and 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, 90 ± 10 days, 120 ± 10 days (if any) after surgery and extubation at the end of treatment. To evaluate the clinical effect of tunneled PICC by comparing the rate of complications of the two groups of patients

• Study Type: Interventional
• Enrollment (Anticipated): 356
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tunneled PICC; Placement of PICC catheter through tunnel technology	Device: tunneled PICC; PICC catheter is inserted into the superior vena cava through the upper brachial vein by establishing a subcutaneous tunnel
Active Comparator: conventional PICC; Placement of PICC catheter through conventional technology	Device: tunneled PICC; PICC catheter is inserted into the superior vena cava through the upper brachial vein by establishing a subcutaneous tunnel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
time of PICC insertion	Time from the start of skin disinfection to the end of dressing fixation	1 hour
Success rate of catheterization	Judgment of successful catheterization: The catheterization is successful and the catheter is placed in an accurate position, that is, the tip of the catheter reaches within 1/3 of the lower part of the superior vena cava or near the junction of the right atrium.	1 hour
score of operation pain	Wong Banker facial expression scale was used. This method uses 6 facial expressions from smile to cry to express the degree of pain: 0 points for no pain, 1 point for slight pain, 2 points for some pain, 3 points for very pain, 4 points for severe pain, and 5 points for unbearable pain	1 hour
rate of unplanned extubation	Extubation after abnormal treatment	120 days
rate of difficulty in decannulation	Probability of failure to pull out PICC due to vasospasm, adhesion with thrombus, wrapping of fibrin sheath, etc	120 days

Collaborators and Investigators

• Sponsor: First People's Hospital of Foshan

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): December 30, 2023

Study Registration Dates

• First Submitted: November 17, 2022
• First Submitted That Met QC Criteria: November 17, 2022
• First Posted (Actual): November 29, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: foshan202271

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No