The Effect of Skin Laxity on the PICC

Complications; Catheter Clinical Trial

— PICC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05629195
• Other study ID #: foshan202271
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2022
• Source: First People's Hospital of Foshan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 356
• Est. completion date: December 30, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Complications; Catheter
• Cutis Laxa

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First People's Hospital of Foshan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time of PICC insertion	Time from the start of skin disinfection to the end of dressing fixation	1 hour
Secondary	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
Secondary	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
Secondary	rate of unplanned extubation	Extubation after abnormal treatment	120 days
Secondary	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