Clinical trial NCT06737432: 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.
Official title: Respiratory Knowledge Portal Application to Reduce Ventilator Associated Events, Ventilator Induced Lung Injury and Alarm Parameter Variance
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
Collaborators: name: Vyaire Medical
First posted: 2024-12-17
Enrollment: 800
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: Number of participants with Ventilator-Associated Events
timeFrame: 3-4 months
Secondary outcomes:
measure: Number of Ventilator Alarm Set Outside of Compliance
timeFrame: 3-4 months
measure: Duration of Days on mechanical ventilation
timeFrame: 3-4 months
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
References: