RKP Monitoring Software for Ventilator-Associated Events

Overseen By Brian K Walsh, PhD, RRT

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Medical Branch, Galveston

Disqualifiers: Non-RKP ICU, High frequency ventilation, ECMO

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the RKP Monitoring Software can improve care for patients using breathing machines in the ICU. The research will assess whether this software helps medical teams follow care protocols more easily and reduce complications. Participants may qualify if they are currently on a breathing machine in a monitored ICU in Galveston. The trial will compare two groups: one using the software and one not using it, to evaluate its impact on patient outcomes. As an unphased trial, this study provides patients the chance to contribute to innovative research that could enhance ICU care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this software is safe for use in monitoring ventilator-associated events?

Research shows that the RKP Monitoring Software is designed to improve care for patients on ventilators. This software quickly and easily identifies issues with ventilator use. Automated systems like this can help reduce complications that occur with prolonged ventilator use.

Specific studies on the safety of the RKP itself are not available, as it is a software tool, not a drug or device that enters the body. However, such software is generally considered safe because it collects and analyzes data without direct patient contact. Previous research has shown that automated systems for monitoring ventilators can reduce errors and improve patient outcomes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RKP Monitoring Software for ventilator-associated events because it introduces a novel approach to patient care in intensive care units. Unlike traditional methods that rely heavily on clinician observation and manual monitoring, RKP provides real-time alerts to support the standard of care, potentially improving response times and patient outcomes. This software could lead to earlier detection of complications, helping reduce the risk of prolonged hospital stays and improving overall patient safety.

What evidence suggests that the RKP Monitoring Software is effective for reducing ventilator-associated events?

Research has shown that automated feedback from ventilators can greatly reduce problems related to their use. One study demonstrated a decrease in these issues from 11.2% to 2.0% with such systems. In this trial, the RKP Monitoring Software is being tested to monitor and improve ventilator use by identifying when care standards are not met. In the "Use of RKP" arm, clinicians will use the software to ensure ventilators are used safely and effectively, potentially leading to better outcomes for patients in critical care. It also aids in managing ventilator use and preparing patients to breathe independently, aiming to reduce complications. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for patients in the ICU who require mechanical ventilation due to various respiratory failures and conditions. It aims to improve their care by reducing complications associated with ventilators.

Inclusion Criteria

Subjects in one of the monitored Galveston campus ICUs

I am between the ages of 0 and 100.

I need a machine to help me breathe.

Exclusion Criteria

Any patient requiring ECMO

Is in an ICU not monitored by RKP

I am an adult using a high-frequency ventilator.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Analysis

Collect quality metrics utilizing RKP from patients requiring mechanical ventilation for a retrospective baseline analysis

3-4 months

Intervention

Provide the RKP tool to the ICU team to determine if the use of RKP's webportal and Messenger Zebra phone app improves quality of mechanical ventilation and outcomes

3-4 months

Follow-up

Participants are monitored for safety and effectiveness after intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• RKP Monitoring Software

Trial Overview The Respiratory Knowledge Portal (RKP) Monitoring Software is being tested. This software collects data on ventilator use, aiming to enhance patient outcomes by adhering to best practice protocols more closely.

How Is the Trial Designed?

Group I: Control Active Control 1 Intervention

We will monitor without clinician use of the software.

Group II: Use of RKP Active Control 1 Intervention

Use of RKP alerts to the standard of care.

Who Is Running the Clinical Trial?

The University of Texas Medical Branch, Galveston

Lead Sponsor

Trials

263

Recruited

55,400+

Vyaire Medical

Industry Sponsor

Trials

11

Recruited

1,800+

Published Research Related to This Trial

A new computer program was developed to enhance quality control and risk management for patients on ventilators, ensuring that the ventilator is safe to use before connecting it to a patient by checking for hardware status and alarm settings.

The software allows for continuous monitoring during ventilation, automatically recording patient data and alarm conditions, which helps clinicians make informed decisions and provides a comprehensive report after the session.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ventilator risk management using a programmed monitor. Silvern, DA., Gupte, PM.[2019]

The study developed and validated predictive models for ICU length of stay and mortality using machine learning algorithms, achieving approximately 89% accuracy for mortality prediction and 65% for length of stay prediction, based on data from the MIMIC database involving adult ICU patients.

The innovative aspect of the research was the use of a quantiles approach to enhance the predictive power of the models by engineering vital sign features, allowing for effective predictions without relying on external data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting Intensive Care Unit Length of Stay and Mortality Using Patient Vital Signs: Machine Learning Model Development and Validation. Alghatani, K., Ammar, N., Rezgui, A., et al.[2021]

The 'SERVO WINDOW' system integrates advanced real-time respiratory monitoring techniques, providing clinicians with continuous access to critical respiratory data such as airway pressure, flow, and CO2 levels, enhancing patient care in anesthesiology.

This system allows for detailed analysis of lung mechanics and blood gas data, with trends updated every minute, which can improve decision-making during surgeries and critical care situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time respiratory monitoring workstation--software and hardware engineering aspects. Govindarajan, N., Meiyappan, S., Prakash, O.[2019]

The implementation of an electronic tool for identifying Ventilator-Associated Events (VAE) at Barnes Jewish Hospital significantly reduced the labor required for manual surveillance by hospital infection prevention staff.

This electronic surveillance system utilizes an internal clinical data repository, enhancing the efficiency of monitoring and potentially improving patient safety by allowing for timely identification of complications related to mechanical ventilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development, Implementation and Use of Electronic Surveillance for Ventilator-Associated Events (VAE) in Adults. Resetar, E., McMullen, KM., Russo, AJ., et al.[2021]

The computer-assisted quality assurance system developed at LDS Hospital allows for efficient monitoring of respiratory care services without the need for time-consuming chart reviews, potentially improving patient outcomes.

By implementing a daily surveillance program, such as the medical director's alert, hospitals can proactively address issues related to inadequate oxygen therapy and airway management, which are significant contributors to preventable deaths, especially among less severely ill patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality assurance for respiratory care services: a computer-assisted program. Elliott, CG.[2000]

Ventilator weaning protocols have been shown to significantly reduce the duration of mechanical ventilation, the incidence of ventilator-associated pneumonia, and the rate of re-intubation compared to physician-directed weaning.

This project aims to enhance adherence to these protocols by continuously monitoring patients' weaning status and providing real-time feedback, potentially leading to better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting adherence to ventilator management and ventilator weaning protocols. Berutti, TW., Starmer, J., Johnson, KB., et al.[2019]

The introduction of a computer-based monitoring system in intensive care has significantly improved the collection, storage, and analysis of vital patient data, enhancing the quality of care since its inception in 1973.

The system now allows for real-time monitoring of critical parameters like heart rate and blood pressure, as well as automated calculations for fluid balance and renal function, which helps reduce nursing workload and improve patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer assisted monitoring in intensive medicine. Lauwers, P., Ferdinande, P., Van de Walle, J., et al.[2011]

The KUSIVAR system is a knowledge-based decision support tool designed to assist medical staff in optimizing respirator treatment by providing real-time advice based on patient data from monitoring equipment.

The system has been developed collaboratively between hospitals, universities, and industry, and is currently undergoing validation and evaluation through animal experiments and clinical studies to ensure its effectiveness and safety in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrating knowledge-based technology into computer aided ventilation systems. Gill, H., Ludwigs, U., Matell, G., et al.[2019]

A new patient categorization and scoring system was developed to objectively measure compliance with mechanical ventilation standards in a pediatric ICU, analyzing data from 222 subjects over 1,578 days of ventilation.

The system showed a median acceptable ventilation score of 84.6% and an acceptable oxygenation score of 70.1%, indicating that while the risk of barotrauma was minimal (100% barotrauma-free state), there was a notable risk of volutrauma (56.1% volutrauma-free state).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Categorization in Mechanically Ventilated Pediatric Subjects: A Proposed Method to Improve Quality. Walsh, BK., Smallwood, CD., Rettig, JS., et al.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06737432

Study Details | NCT06737432 | Respiratory Knowledge ... This quality improvement project will leverage Vyaire's Respiratory Knowledge Portal (RKP) to collect and store meaningful data regarding ventilator-associated ...

2. withpower.com withpower.com/trial/phase-respiratory-insufficiency-5-2024-b0be7

RKP Monitoring Software for Ventilator-Associated Events This quality improvement project will leverage Vyaire's Respiratory Knowledge Portal (RKP) to collect and store meaningful data regarding ventilator-associated ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8021382/

Automated Near Real-Time Ventilator Data Feedback ... Automated ventilator data feedback reduced ventilator-associated events from 11.2% to 2.0% in the intervention group, with no difference in ...

4. zoll.com zoll.com/en-us/products/emergency-care/ventilators/respiratory-knowledge-portal

ZOLL Respiratory Knowledge Portal The ZOLL RKP displays ventilator data, provides patient info, supports ventilator management, helps with weaning, and identifies patient readiness to wean.

5. cdc.gov cdc.gov/nhsn/pdfs/pscmanual/10-vae_final.pdf

Ventilator-associated Event (VAE) Ventilator-associated events (VAE) are complications that can occur in patients receiving mechanical ventilation, such as VAP, sepsis, and ARDS.

6. slideshare.net slideshare.net/slideshow/vyaire-respiratory-knowledge-portal/85610289

Vyaire Respiratory Knowledge Portal | PPTX The Respiratory Knowledge Portal serves as an analytics tool to help hospitals manage ventilator therapy, enhance compliance with sedation and infection ...