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.

The University of Texas System (UT)

Status: Enrolling

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

Treatments: Other: RKP Monitoring Software

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06737432

22-0313

Details and patient eligibility

About

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.

Enrollment: 800 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

800 participants in 2 patient groups

Control

No Intervention group

Description:

We will monitor without clinician use of the software.

Use of RKP

Active Comparator group

Description:

Use of RKP alerts to the standard of care.

Treatment:

Other: RKP Monitoring Software