Cancer, Infections, Phlebitis, Thrombus
Conditions
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
Interventions
DEVICEtunneled 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
DEVICEroutine 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.
Sponsors
Hainan Cancer Hospital
Shandong Branden Med.Device Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of complications | 120 days after operation |
Secondary
| Measure | Time frame |
|---|---|
| time of catheter retention | 7, 30, 60, 90 and 120 days after operation |
Other
| Measure | Time frame |
|---|---|
| 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 |
| incidence of difficulty in pulling out the tube | 7, 30, 60, 90 and 120 days after operation |
Outcome results
None listed