Optimizing home mechanical ventilation for children
Remote Monitoring to Optimize Ventilatory Support in Children With Invasive Home Mechanical Ventilation
NA · Ann & Robert H Lurie Children's Hospital of Chicago · NCT06055413
This study is testing if using remote monitoring can help children with breathing problems who need home ventilation breathe easier and improve their quality of life.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Ann & Robert H Lurie Children's Hospital of Chicago (other) |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06055413 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of remote patient monitoring to enhance the management of invasive home mechanical ventilation in children with chronic respiratory issues. By collecting longitudinal physiological data and patient-reported outcomes over four months, the study aims to reduce the level of ventilatory support needed while improving the quality of life for both patients and their families. The approach focuses on integrating this data into routine clinical care to facilitate better decision-making and support for families. The study will also assess the usability of this monitoring within family life and healthcare provider workflows.
Who should consider this trial
Good fit: Ideal candidates are children aged 0 to 17 who require invasive mechanical ventilation at home and have a family caregiver trained in its use.
Not a fit: Patients who are already off ventilation during the day or have conditions that preclude reducing ventilatory support will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective management of home ventilation, reducing hospital visits and improving children's overall quality of life.
How similar studies have performed: While remote patient monitoring is increasingly used in healthcare, this specific approach for optimizing home mechanical ventilation in children is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Chicago, Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (RECRUITING)
Study contacts
- Principal investigator: Carolyn C Foster, MD, MS — Ann & Robert H Lurie Children's Hospital of Chicago
- Study coordinator: Carolyn C Foster, MD, MS
- Email: ccfoster@luriechildrens.org
- Phone: 312-227-4000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventilator Weaning, Children with medical complexity, Home mechanical ventilation, Long-term ventilation, Remote patient monitoring, Digital health