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.

NCT ID: NCT06737432

Last Updated: 2025-05-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-01
• Study Completion Date: 2026-05-31

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control

We will monitor without clinician use of the software.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Use of RKP

Use of RKP alerts to the standard of care.

Group Type: ACTIVE_COMPARATOR

RKP Monitoring Software

Intervention Type: OTHER

Use of RKP alerting and monitoring software.

Interventions

RKP Monitoring Software

Use of RKP alerting and monitoring software.

Intervention Type: OTHER

Eligibility Criteria

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.

• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vyaire Medical

INDUSTRY

Sponsor Role: collaborator

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Brian K Walsh, PhD, RRT

Role: CONTACT

bkwalsh@utmb.edu

409-772-9283

Facility Contacts

Brian K Walsh, PhD, RRT

Role: primary

bkwalsh@utmb.edu

409-772-9283

Other Identifiers

22-0313

Identifier Type: -

Identifier Source: org_study_id