Patients Requiring Peripherally Inserted Central Venous Catheters
Conditions
Brief summary
This study was a prospective, multicenter, randomized controlled study. The study aimed to exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on the positioning accuracy of catheter tip and exploring the influence of PICC intra catheter guide wire or PICC conductive tip as intra luminal electrode on catheterization complications.
Interventions
DEVICEPICC
Peripheral central venous catheterization (PICC) is mainly applied to patients with medium and long-term intravenous infusion, infusion of stimulant drugs and intermittent infusion of chemotherapy drugs. It is a catheterization technology to place PICC through peripheral veins and make its tip reach the central vein
Sponsors
Third Affiliated Hospital, Sun Yat-Sen University
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients ≥18 years old who need PICC catheterization for the first time according to the doctor's advice; * No serious cardiovascular diseases before catheterization, such as atrial fibrillation, pulmonary heart disease and other P wave abnormalities, serious heart block, etc.; * patients who did not participate in other clinical studies; * Patients who voluntarily participated in the clinical study, signed informed consent and cooperated with clinical follow-up
Exclusion criteria
* patients with local malformation or scar formation; * Patients with infection or damage at the puncture site; * patients with tumor compression of blood vessels; * Patients with confirmed or suspected catheter-related infection, bacteremia and septicemia * Patients diagnosed or suspected to be allergic to silicone material * Patients with a history of radiotherapy at the pre-intubation site * Patients with a history of venous thrombosis, trauma or vascular surgery * Patients with superior vena cava syndrome * Patients with poor medical behavior * Patients with severe peripheral vascular edema * High-flow fluid infusion, patients requiring hemodialysis, pacemaker installation, crutches, or patients who may undergo A-V fistula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of tip determination | Immediately after surgery | IC-ECG method was used to place the tube, and X-ray was used to determine the accuracy of tip location after confirmation. If the two judgments are inconsistent, the third method, such as echocardiography, shall be used. The tip determination accuracy of IC-ECG localization method and X-ray localization method were calculated respectively.X-ray judgment standard: the reference standard is the first choice of the cardiac shadow method: not exceeding the highest protrusion on the left side of the cardiac shadow (tracheal protrusion method: 0-3cm below the tracheal protrusion); Secondary rib reading method: posterior 5-7 ribs. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| success rate of one catheterization | Immediately after surgery | one-time successful catheterization means that the tip of the catheter can be placed at the ideal position in one catheterization operation, without adjustment after X-ray confirmation. After catheterization, both groups of patients need to verify whether the tip is in the ideal position through X-ray, and whether the operation is successful also needs to be judged through X-ray, and the X-ray results need to be retained (random number, center code, initials, time). All results will be sent to the central laboratory for analysis and interpretation. |
| rate of convenient | Immediately after surgery | survey whether the operators think the operation is convenient through questionnaires made by ourselves. |
| incidence of PICC-related complications | After the operation to 180 days | Complications related to puncture and catheter during tube placement and retention include redness and swelling, bleeding, exudation, puncture point infection, ectopic catheter, displacement, catheter blockage, rupture, phlebitis and thrombosis. |
| Retention duration | After the operation to 180 days | — |
| Medical costs resulting from complications | After the operation to 180 days | — |
| rate of unplanned extubation | After the operation to 180 days | Proportion of early removal due to complications |
Outcome results
None listed