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

NCT ID: NCT05870449

Last Updated: 2023-05-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1666 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2024-12-31

Brief 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

Conditions

Cancer; Thrombus; Phlebitis; Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

trial group

Group Type: EXPERIMENTAL

tunneled PICC

Intervention Type: DEVICE

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

control group

Group Type: ACTIVE_COMPARATOR

routine PICC

Intervention Type: DEVICE

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.

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hainan Cancer Hospital

OTHER

Sponsor Role: collaborator

Shandong Branden Med.Device Co.,Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

hainan-01

Identifier Type: -

Identifier Source: org_study_id