What is the mechanism of action of this treatment?

The primary concern in infusion therapy is the presence of air bubbles, which can lead to air embolisms and serious complications. Devices like the ivAED™ are designed to detect and remove these air bubbles from IV infusion lines. The mechanism involves continuous monitoring and elimination of air bubbles before they can enter the patient's bloodstream. This is crucial for patient safety, as it significantly reduces the risk of air embolism, ensuring a safer and more effective infusion process.

What side effects are associated with this type of intervention?

Common side effects of IV infusion treatments include phlebitis, infiltration, and infection at the infusion site. Air bubbles in IV lines can lead to air embolism, which is a serious but rare complication that can cause chest pain, difficulty breathing, and in severe cases, cardiovascular collapse. Other general side effects may include allergic reactions to the infused substances, fluid overload, and electrolyte imbalances.

What prior FDA approvals exist?

The FDA has approved various devices and treatments aimed at improving the safety and efficacy of IV infusion therapy. These include advanced IV infusion pumps designed to minimize the risk of air bubbles, such as the Braun Infusomat® Space P and the Becton-Dickenson Alaris™ model 8100 pump. These devices incorporate features to detect and eliminate air-in-line issues, thereby reducing the risk of air embolism and ensuring accurate medication delivery. While specific FDA approvals for devices like the ivAED™ that specifically target air bubble prevention are not detailed, the ongoing development and testing of such technologies highlight the industry's commitment to enhancing IV infusion safety.

What other types of research exist?

As of 2024, promising novel alternatives to the ivAED™ device for preventing air bubbles in IV infusion lines include advanced IV infusion pumps with integrated air detection and elimination systems, such as the latest models from Braun and Becton-Dickenson. These pumps are designed to minimize air bubble formation and improve patient safety by incorporating more sophisticated air-in-line detection and automatic air removal features.

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ivAED™ Device for Infusion Alarm Reduction

N/A

Waitlist Available

Led By J. Perrin Cobb, MD

Research Sponsored by Herrick Medical LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up patients will participate in the study from the time of enrollment in the icu for up to 3 days

Awards & highlights

No Placebo-Only Group

Summary

This trial tests the ivAED™ device, which removes air bubbles from IV infusions, in patients at Keck Hospital of USC. The goal is to prevent air from entering the bloodstream and disrupting treatment.

Who is the study for?

This trial is for adult patients in the Surgical ICU receiving IV infusions who, or whose surrogates, have given written consent. It excludes those who haven't consented, children under 18 years old, pregnant individuals, and prisoners.

What is being tested?

The study tests if the ivAED device can reduce 'air-in-line' alarms during IV infusion by comparing two pumps: Braun Infusomat Space P and Becton-Dickenson Alaris model 8100 (current standard at Keck Hospital).

What are the potential side effects?

Since this trial involves a device to improve IV infusion rather than a drug, traditional side effects are not applicable. However, there may be technical issues with the device that could affect infusion accuracy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ patients will participate in the study from the time of enrollment in the icu for up to 3 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~patients will participate in the study from the time of enrollment in the icu for up to 3 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and patients will participate in the study from the time of enrollment in the icu for up to 3 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Disruption of nursing workflow, measured as number of minutes required to attend to alarm and restore infusion flow.

Number of air-in-line IV infusion alarms (as detected by the IV infusion pump)

Secondary study objectives

Cost

Loss of Infusate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Standard pump and ivEAD tubingExperimental Treatment1 Intervention

ivEAD tubing

Group II: Braun Infusomat Pump and ivEAD tubingExperimental Treatment1 Intervention

ivEAD tubing

Group III: Braun Infusomat Pump and standard tubingActive Control1 Intervention

Standard tubing

Group IV: Standard infusion pump and standard tubingActive Control1 Intervention

Standard tubing

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ivEAD tubing kit

2021

N/A

~60

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary concern in infusion therapy is the presence of air bubbles, which can lead to air embolisms and serious complications. Devices like the ivAED™ are designed to detect and remove these air bubbles from IV infusion lines. The mechanism involves continuous monitoring and elimination of air bubbles before they can enter the patient's bloodstream. This is crucial for patient safety, as it significantly reduces the risk of air embolism, ensuring a safer and more effective infusion process.

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