Completed

NCT Number: NCT04962516

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

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

Completed

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Key information

Conditions

Single-use Precision Filter Infusion Set

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beijing Friendship Hospital, Beijing, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients with positive pregnancy test in women of childbearing age or lactating women;
Patients with uncontrollable cardiomyopathy, heart failure and unable to tolerate infusion;
Patients with uncontrollable decompensated renal function, especially in the anuric phase of acute renal failure and unable to tolerate infusion;
Patients with uncontrollable extensive inflammation of the lung parenchyma, pulmonary congestion, pulmonary edema and unable to tolerate infusion;
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;

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

Treatment and study plan

single-use precision filtered infusion sets

Device

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

single-use precision filter infusion set with needle

Device

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

Primary outcomes

Vital signs

Time frame: 2 hr after injection

changes in breathing, resting heart rate, blood pressure, body temperature, etc
Vital signs

Time frame: 24 hr after injection

changes in breathing, resting heart rate, blood pressure, body temperature, etc
adverse events and complications

Time frame: 2 hr after injection

The incidence of adverse events and complications
adverse events and complications

Time frame: 24 hr after injection

The incidence of adverse events and complications
number of heat source reactions

Time frame: 2 hr after injection

Heat source reactions caused by the application of extension tubes, such as nausea, vomiting, chills, fever, etc., are key safety indicators
number of heat source reactions

Time frame: 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

Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Collaborators

Beijing Friendship Hospital

Registry information

Official study title

Open, Randomized, Parallel Controlled Clinical Trial to Evaluate the Safety and Efficacy of Single-use Precision Filtered Infusion Sets for Intravenous Infusion

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2019
First posted: Jul 15, 2021
Registry last updated: Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.