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This clinical trial is a prospective, multi-centre, open, parallel and comparative non-inferior trial design.
Four clinical trial institutions that meet the national qualification are selected as clinical research centers. After informed consent of the subjects and meeting the selection criteria, the subjects will be included in this clinical study. After the follow-up, all the data were sorted out and analyzed. Finally, the data of the two groups were compared to prove whether the high-pressure-resistant peripherally inserted central venous catheter developed by L&Z US, Inc. was not inferior to the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Peripheral implantation of central venous catheters and accessories with high pressure tolerance |
|
| Control group | Experimental | Peripheral intubation of central venous catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICC with high pressure tolerance | Device | Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the experimental group and given the intervention. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful rate of one-time catheterization | Subcutaneous detection of blood vessel movements less than three times, and finally completed catheterization and confirmed that the end of the catheter in the pre-positioning proportion of the total number of patients (catheterization success refers to the chest X-ray and other fluoroscopy means to confirm that the end of the catheter is located in the middle and lower segment of superior vena cava). | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Operating time | The time between the beginning of disinfection of the patient's skin and the fixing of transparent dressing is in minutes. | Day 1 |
| success rate of one puncture. | Success of one puncture refers to entering the target vein only once. If the puncture needle failed to penetrate the vein once and retreated to the subcutaneous area, then exploratory puncture was the second puncture. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jin jingfen, Master | The second affiliated hosital of medical college of zhejiang university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Fudan University | Shanghai | Shanghai Municipality | China | |||
| Sir Run Run Shaw Hospital |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002406 | Catheterization, Peripheral |
| ID | Term |
|---|---|
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D057510 | Endovascular Procedures |
| D014656 | Vascular Surgical Procedures |
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|
| rontine central venous catheter | Device | Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the control group and given the intervention. |
|
| Day 1 |
| The incidence of adverse events | Record the adverse events in the test, determine whether they are related to the test product, and calculate the incidence of adverse events/reactions. | about three months |
| Hangzhou |
| Zhejiang |
| 310000 |
| China |
| Zhejiang Provincial Tongde Hospital | Hangzhou | Zhejiang | 310000 | China |
| Second Affiliated Hospital, School of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310009 | China |
| D013504 |
| Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D008919 | Investigative Techniques |