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

Open, Randomized, Parallel Controlled Clinical Trial to Evaluate 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

Study Overview

• Status: Completed
• Conditions: Single-use Precision Filter Infusion Set
• Intervention / Treatment: Device: single-use precision filtered infusion sets; Device: single-use precision filter infusion set with needle

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 Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital
  • Beijing, China
    • Beijing Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Control group	Device: single-use precision filter infusion set with needle; single-use precision filter infusion set with needle (Shandong Zhongbao Kang Medical Apparatus Co., Ltd.)
Test group	Device: single-use precision filtered infusion sets; single-use precision filter infusion set (Dalian JMS Medical Apparatus Co., Ltd.)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vital signs	changes in breathing, resting heart rate, blood pressure, body temperature, etc	2 hr after injection
Vital signs	changes in breathing, resting heart rate, blood pressure, body temperature, etc	24 hr after injection
adverse events and complications	The incidence of adverse events and complications	2 hr after injection
adverse events and complications	The incidence of adverse events and complications	24 hr after injection
number of heat source reactions	Heat source reactions caused by the application of extension tubes, such as nausea, vomiting, chills, fever, etc., are key safety indicators	2 hr after injection
number of heat source reactions	Heat source reactions caused by the application of extension tubes, such as nausea, vomiting, chills, fever, etc., are key safety indicators	24 hr after injection

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Collaborators: Beijing Friendship Hospital
• Investigators: Principal Investigator: Baohua Li, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): July 1, 2019

Study Registration Dates

• First Submitted: June 27, 2021
• First Submitted That Met QC Criteria: July 4, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: D2018091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No