Respiratory Knowledge Portal Computer and Phone Application to Improve Quality of Mechanical Ventilation by Reducing the Number of Ventilator Associated Events, Injury Created by the Ventilator and Unsafe Setting of Alarms.

Respiratory Knowledge Portal Application to Reduce Ventilator Associated Events, Ventilator Induced Lung Injury and Alarm Parameter Variance

Ventilator associated events (VAE) is a quality metric defined by 48 hours of stability followed by 48 hours of escalation of ventilator settings within the ICU. VAE have been associated with poor outcomes and increases the cost of care, yet is not easy to avoid. Operationalizing all the standards of care known to improve outcomes of those requiring mechanical ventilation in the critical care environment requires a comprehensive approach. ICU teams are encouraged to follow best practice protocols to help liberate and prevent VAEs. Yet, compliance with protocols in most ICUs is suboptimal for multiple reasons. With the advent of computerized mechanical ventilators capable of streaming data from breath to breath and biomedical integration systems (BMDI) such as Capsule (UTMB's BMDI system), software systems have been developed to help identify variances in the standard of care. Automation in near real-time ventilator data feedback has been shown to reduce the incidences of VAEs.

This quality improvement project will leverage Vyaire's Respiratory Knowledge Portal (RKP) to collect and store meaningful data regarding ventilator-associated events (VAE), alarm policy compliance, ventilator weaning, and lung protective analytics.

Goals:

1. To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis.
2. 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. To determine a return on investment (ROI) for a software system like RKP.

Study Overview

• Status: Active, not recruiting
• Conditions: Respiratory Failure; Ventilation; ARDS; Mechanical Ventilation; Quality Improvement; Ventilator Associated Events; Ventilator-induced Lung Injury (VILI)
• Intervention / Treatment: Other: RKP Monitoring Software

• Study Type: Interventional
• Enrollment (Actual): 875
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Galveston, Texas, United States, 77555
      • University of Texas Medical Branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects requiring invasive mechanical ventilation.
2. Subjects is in one of the monitored Galveston campus ICUs.
3. Ages 0-100

Exclusion Criteria:

1. Is in an ICU not monitored by RKP.
2. Adults on high frequency ventilation (pediatric patients are NOT excluded).
3. Any patient requiring ECMO.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; We will monitor without clinician use of the software.
Active Comparator: Use of RKP; Use of RKP alerts to the standard of care.	Other: RKP Monitoring Software; Use of RKP alerting and monitoring software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Ventilator-Associated Events	3-4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Ventilator Alarm Set Outside of Compliance	Ventilator alarms set by the RT	3-4 months
Duration of Days on mechanical ventilation	Does the weaning of mechanical ventilation improve through the measurements of spontaneous breathing trials.	3-4 months

Collaborators and Investigators

• Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Zoll Medical Corporation; Vyaire Medical

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: December 11, 2024
• First Posted (Actual): December 17, 2024

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Mechanical ventilation; Computer aided mechanical ventilation; Mechanical ventilation quality; Mechanical ventilation safety; Ventilator monitoring application
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders; Lung Injury; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiratory Aspiration; Ventilator-Induced Lung Injury
• Other Study ID Numbers: 22-0313

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