VentilationNCT06737432
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.
A study testing RKP Monitoring Software in people with Ventilation and ARDS, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Ventilation, ARDS, Respiratory Failure
- What is being tested?
- RKP Monitoring Software
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 875 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects requiring invasive mechanical ventilation.
- Subjects is in one of the monitored Galveston campus ICUs.
- Ages 0-100
Who cannot join
- Is in an ICU not monitored by RKP.
- Adults on high frequency ventilation (pediatric patients are NOT excluded).
- Any patient requiring ECMO.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Respiratory Knowledge Portal Application to Reduce Ventilator Associated Events, Ventilator Induced Lung Injury and Alarm Parameter Variance
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.
Read more
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.
- Conditions
- Ventilation, ARDS, Respiratory Failure, Mechanical Ventilation, Ventilator-induced Lung Injury (VILI), Quality Improvement
- Being tested
- RKP Monitoring Software
- Keywords
- Computer aided mechanical ventilation, Mechanical ventilation quality, Mechanical ventilation, Mechanical ventilation safety, Ventilator monitoring application
- Medical subject headings
- Respiratory Aspiration, Respiratory Insufficiency, Ventilator-Induced Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RKP Monitoring SoftwareOther
Use of RKP alerting and monitoring software.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: RKP Monitoring Software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Ventilator-Associated Events
Measured: 3-4 months
Secondary outcomes (2)
Number of Ventilator Alarm Set Outside of Compliance
Ventilator alarms set by the RT
Measured: 3-4 months
Duration of Days on mechanical ventilation
Does the weaning of mechanical ventilation improve through the measurements of spontaneous breathing trials.
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Jun 2024
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 875 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Medical Branch, Galveston
- Sponsor type
- University, hospital or other
- Collaborators
- Vyaire Medical, Zoll Medical Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737432
- Sponsor's protocol ID
- 22-0313
- Status last verified
- Apr 2026
- First submitted
- 11 Jul 2024
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Knowledge Portal Application to Reduce Ventilator Associated Events, Ventilator Induced Lung Injury and Alarm Parameter Variance
- ClinicalTrials.gov ID
- NCT06737432
- Acronym / sponsor ID
- 22-0313
- Conditions
- Ventilation, ARDS, Respiratory Failure, Mechanical Ventilation, Ventilator-induced Lung Injury (VILI), Quality Improvement
- Keywords
- Computer aided mechanical ventilation, Mechanical ventilation quality, Mechanical ventilation, Mechanical ventilation safety, Ventilator monitoring application
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 875 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Collaborators
- Vyaire Medical, Zoll Medical Corporation
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –We will monitor without clinician use of the software. |
| Use of RKP | Active comparator | Other: RKP Monitoring SoftwareUse of RKP alerts to the standard of care. |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects requiring invasive mechanical ventilation.
- Subjects is in one of the monitored Galveston campus ICUs.
- Ages 0-100
Key exclusion criteria (3 listed)
- Is in an ICU not monitored by RKP.
- Adults on high frequency ventilation (pediatric patients are NOT excluded).
- Any patient requiring ECMO.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RKP Monitoring SoftwareUse of RKP alerting and monitoring software. | Other | Use of RKP |
Primary outcome
Number of participants with Ventilator-Associated Events
Time frame: 3-4 months
2 secondary outcomes
Number of Ventilator Alarm Set Outside of Compliance
Time frame: 3-4 months
Duration of Days on mechanical ventilation
Time frame: 3-4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RKP Monitoring Software in people with Ventilation and ARDS, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Ventilator-Associated Events (time frame: 3-4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.