Respiratory Knowledge Portal Computer and Phone Applicati... | NCT06737432

Studies
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

Sponsor

The University of Texas Medical Branch, Galveston

Status

Active, not recruiting

Last Update Posted

Apr 8, 2026Actual

Enrollment

875Actual

Phase

Not Applicable

Conditions

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

Interventions

RKP Monitoring Software

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2024Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Jul 11, 2024

First Submission Date that Met QC Criteria

Dec 11, 2024

First Posted Date

Dec 17, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2026

Last Update Posted Date

Apr 8, 2026Actual

Name	Class
Vyaire Medical	INDUSTRY
Zoll Medical Corporation	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis.
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.
To determine a return on investment (ROI) for a software system like RKP.

Detailed Description

Not provided

Conditions Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

875Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
RKP Monitoring Software	Other	Use of RKP alerting and monitoring software.	Use of RKP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of participants with Ventilator-Associated Events		3-4 months

Secondary Outcomes

Measure	Description	Time Frame
Number of Ventilator Alarm Set Outside of Compliance	Ventilator alarms set by the RT	3-4 months
Duration of Days on mechanical ventilation	Does the weaning of mechanical ventilation improve through the measurements of spontaneous breathing trials.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

100 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Texas Medical Branch		Galveston	Texas	77555	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D053120	Respiratory Aspiration
D012131	Respiratory Insufficiency
D055397	Ventilator-Induced Lung Injury

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D055370	Lung Injury
D008171	Lung Diseases