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.

NCT06737432 | Active Not Recruiting

• 1 other identifier: 22-0313
• Study Type: interventional
• Target: 875
• Locations: 1 country
• Sites: 1

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. 1.To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis.
2. 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. 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

Keywords

Computer aided mechanical ventilation; Mechanical ventilation quality; Mechanical ventilation; Mechanical ventilation safety; Ventilator monitoring application

Outcome Measures

Primary Outcomes (1)

• Number of participants with Ventilator-Associated Events

  3-4 months

Secondary Outcomes (2)

• Number of Ventilator Alarm Set Outside of Compliance

  3-4 months

• Duration of Days on mechanical ventilation

  3-4 months

Study Arms (2)

Control

NO INTERVENTION

We will monitor without clinician use of the software.

Use of RKP

ACTIVE COMPARATOR

Use of RKP alerts to the standard of care.

Other: RKP Monitoring Software

Interventions

RKP Monitoring Software OTHER

Use of RKP alerting and monitoring software.

Use of RKP

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vyaire Medical: collaborator
• The University of Texas Medical Branch, Galveston: lead
• Zoll Medical Corporation: collaborator

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Respiratory Aspiration; Respiratory Insufficiency; Ventilator-Induced Lung Injury

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Injury; Lung Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Monitoring 3-4 months prior to intervention or use of the software.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: December 17, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)