Evaluation of the Safety and Efficacy of Single-use Precision Filtered Infusion Sets for Intravenous Infusion

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

168 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-01

Study Completion Date

2019-07-01

Brief Summary

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This study is a pre-market clinical trial of a single-use precision filter infusion set for pumps, to evaluate the safety and effectiveness of a single-use precision filter infusion set for pumps after being used in humans, and to provide clinical evidence for the official application of the product in China

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Detailed Description

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This experiment compares the single-use precision filter infusion set produced by Shandong Xinhua Ande Medical Products Co., Ltd. for the same intended use that has been approved to market, and compares the performance of the two products in clinical use, the overall pass rate, and the occurrence of phlebitis Rates and adverse events are used to evaluate the safety and effectiveness of single-use precision filtration infusion sets for pumps.

Conditions

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Single-use Precision Filter Infusion Set

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Test group

single-use precision filtered infusion sets

Intervention Type DEVICE

single-use precision filter infusion set (Dalian JMS Medical Apparatus Co., Ltd.)

Control group

single-use precision filter infusion set with needle

Intervention Type DEVICE

single-use precision filter infusion set with needle (Shandong Zhongbao Kang Medical Apparatus Co., Ltd.)

Interventions

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single-use precision filtered infusion sets

single-use precision filter infusion set (Dalian JMS Medical Apparatus Co., Ltd.)

Intervention Type DEVICE

single-use precision filter infusion set with needle

single-use precision filter infusion set with needle (Shandong Zhongbao Kang Medical Apparatus Co., Ltd.)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. age 18 years or older, gender not limited;
2. intravenous infusion requiring drug filtration, flow regulation, dosing and extension of infusion line;
3. not participating in other clinical trials within one month;
4. able to understand the purpose of the trial, voluntarily participate and sign the informed consent;
5. willing to follow up and evaluate according to the requirements of the trial protocol.

Exclusion Criteria

1. Patients with positive pregnancy test in women of childbearing age or lactating women;
2. Patients with uncontrollable cardiomyopathy, heart failure and unable to tolerate infusion;
3. Patients with uncontrollable decompensated renal function, especially in the anuric phase of acute renal failure and unable to tolerate infusion;
4. Patients with uncontrollable extensive inflammation of the lung parenchyma, pulmonary congestion, pulmonary edema and unable to tolerate infusion;
5. 0.2um size Test devices combined with any of the following drugs or preparations: fatty milk type, blood products type (blood cells, globulin, etc.), drugs that will produce insoluble precipitates with each other, etc.; 6, patients who are clinically infused with very small amounts of drugs (due to residual test line may reduce the amount of drugs delivered to patients); 7, puncture sites with inflammation, tumors, trauma, scars, etc.; 8, those who may be allergic to product materials; 9 Patients with AIDS;

10\. Patients with mental disorders; 11. Other patients who are considered by the investigator to be unsuitable for participation in this study

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No