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

Not Applicable

Not yet recruiting

• Conditions: Cancer; Phlebitis; Infections; Thrombus
• Interventions: Device: routine PICC; Device: tunneled PICC

• Registration Number: NCT05870449
• Lead Sponsor: Shandong Branden Med.Device Co.,Ltd

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-06
• Study First Submitted QC: 2023-05-22
• Last Update Submitted: 2023-05-22
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23
• Study Start: 2023-07-01
• Primary Completion: 2024-07-01
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1666

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	routine PICC	-
trial group	tunneled PICC	-

Primary Outcome Measures

Name	Time	Method
rate of complications	120 days after operation

Secondary Outcome Measures

Name	Time	Method
time of catheter retention	7, 30, 60, 90 and 120 days after operation