Effects of ivAED™ Device on "Air-in-line" Alarms and Workflow Disruption

February 27, 2023 updated by: Herrick Medical LLC

Optimizing Value in Critical Care: Effect of Braun Infusomat®Space I IV Infusion Pump and ivEAD™ Air Elimination Device on "Air-in-line" Alarms and Workflow Disruption

The investigators propose to test the hypothesis, that is, the effectiveness of the ivAED to eliminate air-in-line, comparing two commercially available, standard IV infusion pumps: the Braun Infusomat® Space P and the Becton-Dickenson Alaris™ model 8100 pump (the latter is currently in use as the standard IV infusion pump at Keck Hospital of USC). Testing of an IV infusion pump other the Keck Hospital of USC standard is indicated, as the independent laboratory testing of the Alaris™ 8100 pump found that this model pump is prone to developing air bubbles as the infusion passes through the pump mechanism. These air bubbles can be sufficient to trigger the air-in-line alarm. The Braun Infusomat® Space P IV infusion pump is a market leader like the Alaris™ 8100 pump, was evaluated in independent testing with and without the ivAED™ device, and was NOT found to create bubbles.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

There are very few controlled human studies in the literature that assess various existing preventative measures for air embolism. After extensive, independent pre-clinical laboratory testing of the ivAED™ device demonstrating efficacy in removing air-in-line from IV infusions (see Appendix 1), this is the first-in-humans, clinical application of the ivAED™ device.

Testing of the ivAED™ device in patients is justified as that is the only means to determine the impact of the device on clinical IV infusion and nursing workflow disruptions (the primary outcomes of the study). Testing of the device in animals, or in healthy volunteers, or in computer simulations cannot provide this real-world information. In addition, the FDA typically requires that laboratory pre-clinical testing be coupled with clinical testing when applying for approval of new, investigational devices.

The investigators propose to test the hypothesis, that is, the effectiveness of the ivAED to eliminate air-in-line, comparing two commercially available, standard IV infusion pumps: the Braun Infusomat® Space P and the Becton-Dickenson Alaris™ model 8100 pump (the latter is currently in use as the standard IV infusion pump at Keck Hospital of USC). Testing of an IV infusion pump other the Keck Hospital of USC standard is indicated, as the independent laboratory testing of the Alaris™ 8100 pump found that this model pump is prone to developing air bubbles as the infusion passes through the pump mechanism. These air bubbles can be sufficient to trigger the air-in-line alarm. The Braun Infusomat® Space P IV infusion pump is a market leader like the Alaris™ 8100 pump, was evaluated in independent testing with and without the ivAED™ device, and was NOT found to create bubbles.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: J. Perrin Cobb, MD
  • Phone Number: 323-442-5849
  • Email: jpcobb@usc.edu

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Surgical ICU patients that are receiving IV infusions
  • Patients or their surrogates have provided written, informed consent

Exclusion Criteria:

  • Patients who do not give consent to our researchers
  • Children (patients <18 years of age)
  • Pregnancy
  • Prisoners

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Braun Infusomat Pump and ivEAD tubing
ivEAD tubing
Device: ivEAD tubing kit
ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
Other Names:
  • Braun Infusomat Pump
  • Standard Infusion Pump
No Intervention: Braun Infusomat Pump and standard tubing
Standard tubing
Experimental: Standard pump and ivEAD tubing
ivEAD tubing
Device: ivEAD tubing kit
ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
Other Names:
  • Braun Infusomat Pump
  • Standard Infusion Pump
No Intervention: Standard infusion pump and standard tubing
Standard tubing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of air-in-line IV infusion alarms (as detected by the IV infusion pump)
Time Frame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Number of air-in-line IV infusion alarms (as detected by the IV infusion pump)
Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Disruption of nursing workflow, measured as number of minutes required to attend to alarm and restore infusion flow.
Time Frame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Disruption of nursing workflow, measured as number of minutes required to attend to alarm and restore infusion flow.
Patients will participate in the study from the time of enrollment in the ICU for up to 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost
Time Frame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Cost of disruption of nursing workflow, as measured by time-driven, activity-based costing
Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Loss of Infusate
Time Frame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Loss of infusate secondary to clearance of air in line
Patients will participate in the study from the time of enrollment in the ICU for up to 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herrick Medical LLC

Collaborators

University of Southern California

Investigators

  • Principal Investigator: J. Perrin Cobb, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2021

Primary Completion (Anticipated)

September 1, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 18, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 27, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HM 001

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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