The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications

Cancer Clinical Trial

— PICC  

Official title:

The Impact of Climate Environment in Different Latitudes on the Occurrence of PICC Complications and Intervention Measures - Prospective, Multicenter, Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05870449
• Other study ID #: hainan-01
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2023
• Source: Shandong Branden Med.Device Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, eligible subjects were randomly assigned to the experimental or control group through randomization (1:1). Under the guidance of electrocardiographic Doppler ultrasound guided puncture and catheterization (EDUG) technology, the tunnel puncture method was compared with the conventional puncture method. The two groups of patients were observed and evaluated intraoperative and postoperative 7 ± 3 days, 30 ± 7 days, 60 ± 10 days, and 90 ± 10 days 120 ± 10 days (if any) and the occurrence of complications during extubation or unplanned extubation at the end of treatment, comparing cases in the north and south, as well as complications related to different catheterization methods

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1666
• Est. completion date: December 31, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 18 years old;

• Patients who follow medical advice and require PICC 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;

• There are no serious cardiovascular diseases, such as atrial fibrillation, pulmonary heart disease, and other P-wave abnormalities before catheterization, as well as severe heart conduction block

Exclusion Criteria:

• Known allergies to catheter materials;

• There is a history of infection, injury, and radiation therapy at the puncture site;

• The puncture site has a history of venous thrombosis or surgery;

• Severe abnormal coagulation function;

• Superior vena cava compression syndrome;

• Surgical side limbs of breast cancer patients undergoing radical mastectomy or axillary lymph node dissection;

• Heart pacemaker and arteriovenous fistula on the same side of the limb;

• Patients or patients' family members refuse to sign the informed consent form.

Related Conditions & MeSH terms

• Cancer
• Infections
• Phlebitis
• Thrombus

Intervention

Device:
• tunneled PICC
Tunneled PICC is a type of PICC catheterization technique that involves establishing a subcutaneous tunnel to keep the outlet of the catheter away from the puncture site
• routine PICC
Peripherally inserted central venous catheterization is a technique that involves inserting PICC through the peripheral vein and infusing drugs into the central vein through a catheter.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Shandong Branden Med.Device Co.,Ltd	Hainan Cancer Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	rate of unplanned extubation		7, 30, 60, 90 and 120 days after operation
Other	Success rate of one-time catheterization		7, 30, 60, 90 and 120 days after operation
Other	Operation time		Immediately after operation
Other	incidence of difficulty in pulling out the tube		7, 30, 60, 90 and 120 days after operation
Primary	rate of complications		120 days after operation
Secondary	time of catheter retention		7, 30, 60, 90 and 120 days after operation