The Effect of Skin Laxity on the PICC

Not Applicable

Not yet recruiting

• Conditions: Complications; Catheter
• Interventions: Device: tunneled PICC

• Registration Number: NCT05629195
• Lead Sponsor: First People's Hospital of Foshan

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).

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 Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-17
• Study First Submitted QC: 2022-11-17
• Last Update Submitted: 2022-11-17
• Study First Posted: 2022-11-29
• Last Update Posted: 2022-11-29
• Study Start: 2022-12-01
• Primary Completion: 2023-09-01
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 356

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
tunneled PICC	tunneled PICC	Placement of PICC catheter through tunnel technology
conventional PICC	tunneled PICC	Placement of PICC catheter through conventional technology

Primary Outcome Measures

Name	Time	Method
rate of PICC complications	120 days	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

Secondary Outcome Measures

Name	Time	Method
time of PICC insertion	1 hour	Time from the start of skin disinfection to the end of dressing fixation
score of operation pain	1 hour	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
Success rate of catheterization	1 hour	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.
rate of unplanned extubation	120 days	Extubation after abnormal treatment
rate of difficulty in decannulation	120 days	Probability of failure to pull out PICC due to vasospasm, adhesion with thrombus, wrapping of fibrin sheath, etc