Clinical trial
Remote Monitoring to Optimize Ventilatory Support in Children With Invasive Home Mechanical Ventilation
Name
2020-3600
Description
Some children who are born very early or have other congenital conditions may develop severe, long-term lung problems that make them need to use a breathing machine to live at home. There are no studies that identify the best ways to monitor a home breathing machine or adjust its settings. Increasingly, healthcare systems are using information collected at home to make more informed decisions about a patient's healthcare treatment, which is called "remote patient monitoring". This study will ask whether using remote patient monitoring can provide more complete information to a child's team of doctors, nurses, and respiratory therapists to help a child's healthcare team and family make more informed decisions about a child's home ventilator care. The investigators are hypothesizing it can safely decrease the level of breathing support children need while also avoiding emergency and hospital care and supporting their growth, development, and participation in daily life.
Trial arms
Trial start
2023-09-20
Estimated PCD
2024-11-11
Trial end
2024-11-11
Status
Recruiting
Treatment
Remote patient monitoring (RPM) bundle
Patient-families will be given a "remote patient monitoring (RPM) bundle" with tools to measure objective and subjective information about the child at home that are shared with the home ventilator provider team through an electronic dashboard. The tools include a device to measure carbon dioxide, a digital tablet, a digital weight scale, and a digital application that connects to the child's electronic health record. Each child will be assigned an individualized remote monitoring schedule (timing and data type) based on their indication for ventilation and ventilator regimen at enrollment.
Arms:
Intervention Arm
Size
50
Primary endpoint
Level of ventilator support
4 months
Eligibility criteria
Family-Patient Inclusion criteria
* The patient uses invasive mechanical ventilation at home during any portion of the day at time of enrollment.
* The patient is 0 to 17 years old.
* The patient has at least one family caregiver (parent or other self-identified legal guardian) trained on home ventilator use who is willing to participate.
* The primary parental participant reads and speaks either English or Spanish.
Exclusion criteria
* The patient has progressive neuromuscular or other condition for which decreasing support during the day is not anticipated.
* The patient is already off of ventilation during the day while awake.
* The patient will turn 18 during participation.
* The patient has planned a transition of care to another institution or move during the planned study period after enrollment.
* The patient is in active hospice or similar end-of-life care at time of study enrollment.
* The patient is living in long-term institution, transitional facility, or not within a stable home setting during the study period.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-09-26
1 organization