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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06737432
Enrollment
875
Registered
2024-12-17
Start date
2024-06-01
Completion date
2026-12-01
Last updated
2026-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

OTHERRKP Monitoring Software

Use of RKP alerting and monitoring software.

Sponsors

The University of Texas Medical Branch, Galveston
Lead SponsorOTHER
Vyaire Medical
CollaboratorINDUSTRY
Zoll Medical Corporation
CollaboratorINDUSTRY

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

Monitoring 3-4 months prior to intervention or use of the software.

Eligibility

Sex/Gender
ALL
Age
No minimum to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Number of participants with Ventilator-Associated Events3-4 months

Secondary

MeasureTime frameDescription
Number of Ventilator Alarm Set Outside of Compliance3-4 monthsVentilator alarms set by the RT
Duration of Days on mechanical ventilation3-4 monthsDoes the weaning of mechanical ventilation improve through the measurements of spontaneous breathing trials.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 4, 2026