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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04962516
• Collaborator: Beijing Friendship Hospital (Other)
• Enrollment: 168
• Locations: 2
• Actual Duration (Months): 12
• Patients Per Site: 84
• Patients Per Site Per Month: 7

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Single-use Precision Filter Infusion Set	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 Design

• Study Type: Observational
• Actual Enrollment: 168 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Open, Randomized, Parallel Controlled Clinical Trial to Evaluate the Safety and Efficacy of Single-use Precision Filtered Infusion Sets for Intravenous Infusion
• Actual Study Start Date: Jul 1, 2018
• Actual Primary Completion Date: Dec 1, 2018
• Actual Study Completion Date: Jul 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Test group	Device: single-use precision filtered infusion sets; single-use precision filter infusion set (Dalian JMS Medical Apparatus Co., Ltd.)
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.)

Outcome Measures

Primary Outcome Measures

1. Vital signs [2 hr after injection]

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

2. Vital signs [24 hr after injection]

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

3. adverse events and complications [2 hr after injection]

   The incidence of adverse events and complications

4. adverse events and complications [24 hr after injection]

   The incidence of adverse events and complications

5. number of heat source reactions [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

6. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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;

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beijing Friendship Hospital	Beijing		China
2	Peking University Third Hospital	Beijing		China

Sponsors and Collaborators

• Peking University Third Hospital
• Beijing Friendship Hospital

Investigators

• Principal Investigator: Baohua Li, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04962516
• Other Study ID Numbers: D2018091
• First Posted: Jul 15, 2021
• Last Update Posted: Jul 15, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 15, 2021