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

NCT05870449 | Unknown

• 1 other identifier: hainan-01
• Study Type: interventional
• Target: 1,666
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• rate of complications

  120 days after operation

Secondary Outcomes (1)

• time of catheter retention

  7, 30, 60, 90 and 120 days after operation

Other Outcomes (4)

• rate of unplanned extubation

  7, 30, 60, 90 and 120 days after operation

• Success rate of one-time catheterization

  7, 30, 60, 90 and 120 days after operation

• Operation time

  Immediately after operation

Study Arms (2)

trial group

EXPERIMENTAL

Device: tunneled PICC

control group

ACTIVE COMPARATOR

Device: routine PICC

Interventions

tunneled PICC 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

trial group

routine PICC 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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Branden Med.Device Co.,Ltd: lead
• Hainan Cancer Hospital: collaborator

MeSH Terms

Conditions

Neoplasms; Thrombosis; Phlebitis; Infections

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Vasculitis

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 23, 2023
• Study Start: July 1, 2023
• Primary Completion: July 1, 2024
• Study Completion: December 31, 2024
• Last Updated: May 23, 2023

Record last verified: 2023-05