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.

Not Applicable

Recruiting

• Conditions: Ventilation; ARDS; Respiratory Failure; Mechanical Ventilation; Ventilator-induced Lung Injury (VILI); Quality Improvement; Ventilator Associated Events

• Registration Number: NCT06737432
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-01
• Study First Submitted: 2024-07-11
• Study First Submitted QC: 2024-12-11
• Study First Posted: 2024-12-17
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-13
• Primary Completion: 2026-03
• Study Completion: 2026-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Number of participants with Ventilator-Associated Events	3-4 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States