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

Completed

• Conditions: Single-use Precision Filter Infusion Set
• Interventions: Device: single-use precision filter infusion set with needle; Device: single-use precision filtered infusion sets

• Registration Number: NCT04962516
• Lead Sponsor: Peking University Third Hospital

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2018-07-01
• Primary Completion: 2018-12-01
• Study Completion: 2019-07-01
• Status Verified: 2021-06
• Study First Submitted: 2021-06-27
• Study First Submitted QC: 2021-07-04
• Last Update Submitted: 2021-07-04
• Study First Posted: 2021-07-15
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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.

Read More

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;

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	single-use precision filter infusion set with needle	-
Test group	single-use precision filtered infusion sets	-

Primary Outcome Measures

Name	Time	Method
number of heat source reactions	24 hr after injection	Heat source reactions caused by the application of extension tubes, such as nausea, vomiting, chills, fever, etc., are key safety indicators
Vital signs	24 hr after injection	changes in breathing, resting heart rate, blood pressure, body temperature, etc
adverse events and complications	24 hr after injection	The incidence of adverse events and complications

Trial Locations

Locations (2)

Beijing Friendship Hospital; 🇨🇳 Beijing, China

Peking University Third Hospital; 🇨🇳 Beijing, China