Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2026-02-20 @ 10:43 PM
Study NCT ID:
NCT06737432
Status:
RECRUITING
Last Update Posted:
2025-05-13
First Post:
2024-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D053120', 'term': 'Respiratory Aspiration'}, {'id': 'D012131', 'term': 'Respiratory Insufficiency'}, {'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}], 'ancestors': [{'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Monitoring 3-4 months prior to intervention or use of the software.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2024-07-11', 'studyFirstSubmitQcDate': '2024-12-11', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Ventilator-Associated Events', 'timeFrame': '3-4 months'}], 'secondaryOutcomes': [{'measure': 'Number of Ventilator Alarm Set Outside of Compliance', 'timeFrame': '3-4 months', 'description': 'Ventilator alarms set by the RT'}, {'measure': 'Duration of Days on mechanical ventilation', 'timeFrame': '3-4 months', 'description': 'Does the weaning of mechanical ventilation improve through the measurements of spontaneous breathing trials.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Computer aided mechanical ventilation', 'Mechanical ventilation quality', 'Mechanical ventilation', 'Mechanical ventilation safety', 'Ventilator monitoring application'], 'conditions': ['Ventilation', 'ARDS', 'Respiratory Failure', 'Mechanical Ventilation', 'Ventilator-induced Lung Injury (VILI)', 'Quality Improvement', 'Ventilator Associated Events']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nGoals:\n\n1. To collect quality metrics utilizing RKP from patients requiring mechanical ventilation over a 3-4-month period for a retrospective baseline analysis.\n2. 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.\n3. To determine a return on investment (ROI) for a software system like RKP."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects requiring invasive mechanical ventilation.\n2. Subjects is in one of the monitored Galveston campus ICUs.\n3. Ages 0-100\n\nExclusion Criteria:\n\n1. Is in an ICU not monitored by RKP.\n2. Adults on high frequency ventilation (pediatric patients are NOT excluded).\n3. Any patient requiring ECMO.'}, 'identificationModule': {'nctId': 'NCT06737432', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Respiratory Knowledge Portal Application to Reduce Ventilator Associated Events, Ventilator Induced Lung Injury and Alarm Parameter Variance', 'orgStudyIdInfo': {'id': '22-0313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'We will monitor without clinician use of the software.'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Use of RKP', 'description': 'Use of RKP alerts to the standard of care.', 'interventionNames': ['Other: RKP Monitoring Software']}], 'interventions': [{'name': 'RKP Monitoring Software', 'type': 'OTHER', 'description': 'Use of RKP alerting and monitoring software.', 'armGroupLabels': ['Use of RKP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Brian K Walsh, PhD, RRT', 'role': 'CONTACT', 'email': 'bkwalsh@utmb.edu', 'phone': '409-772-9283'}], 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'centralContacts': [{'name': 'Brian K Walsh, PhD, RRT', 'role': 'CONTACT', 'email': 'bkwalsh@utmb.edu', 'phone': '409-772-9283'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'collaborators': [{'name': 'Vyaire Medical', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}