Home-based Optimization of Mechanical Ventilation in Children

Ventilator Weaning Clinical Trial

— HOMVent4Kids  

Official title:

Remote Monitoring to Optimize Ventilatory Support in Children With Invasive Home Mechanical Ventilation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06055413
• Other study ID #: 2020-3600
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2023
• Est. completion date: November 11, 2024

Study information

• Verified date: September 2023
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: Carolyn C Foster, MD, MS
• Phone: 312-227-4000
• Email: ccfoster[@]luriechildrens.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This is a single-arm, non-randomized, open-label trial using remote patient monitoring for chronic management of invasive home mechanical ventilation in children. The investigators hypothesize that integration of longitudinal physiologic data and patient reported outcome measures into routine clinical care over 4 months can optimize home mechanical ventilation use by 1) reducing the level home mechanical ventilation level of support, 2) improving patient and family quality of life, specifically participation in daily activities and patient's lung symptoms, and 3) improving family-reported shared decision-making and child's access to ventilator care. The investigators will also evaluate its usability within family life and provider workflows and assess early implementation outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: November 11, 2024
• Est. primary completion date: November 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ventilator Weaning

Intervention

Combination Product:
• 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.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (2)

Foster C, Noreen P, Grage J, Kwon S, Hird-McCorry LP, Janus A, Davis MM, Goodman D, Laguna T. Predictors for invasive home mechanical ventilation duration in bronchopulmonary dysplasia. Pediatr Pulmonol. 2023 Jul;58(7):2085-2093. doi: 10.1002/ppul.26437. Epub 2023 Apr 28. — View Citation

Foster CC, Kwon S, Shah AV, Hodgson CA, Hird-McCorry LP, Janus A, Jedraszko AM, Swanson P, Davis MM, Goodman DM, Laguna TA. At-home end-tidal carbon dioxide measurement in children with invasive home mechanical ventilation. Pediatr Pulmonol. 2022 Nov;57(11):2735-2744. doi: 10.1002/ppul.26092. Epub 2022 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of ventilator support	Liters/kg/day	4 months
Secondary	Cessation of awake positive pressure	Percentage of patients on any positive pressure ventilation during the day (per post discharge days)	4 months
Secondary	Cessation of positive pressure	Percentage of patients on any positive pressure ventilation at any time (per post discharge days)	4 months
Secondary	Ventilator management frequency	Number of ventilator management changes made per patient	4 months
Secondary	Quality of life via participation	Two questions asking about to what extent the child's health issues interfered the child and the parent's with ability to engage in their usual activities. The questions are scored as 1, Not at all, 2, Slightly, 3, Moderately, 4, Quite a lot , 5, Extremely regarding how much the child's health affecting activity participation.	4 months
Secondary	Lung symptom control	Parent report using bronchopulmonary dysplasia survey measure	4 months
Secondary	Level of shared decision making	National Survey of Children's Health; shared decision-making survey questions	4 months
Secondary	Perceived access to ventilator care	Parent reported survey measure of their child's access to ventilator care	4 months
Secondary	Child growth	Patient height and weight (absolute and Z scores)	4 months
Secondary	Child healthcare utilization	Number of emergency department visits and hospitalizations.	4 months
Secondary	Reach	To what degree potential patient participants participated, defined by comparing how many were approached versus participated.	4 months
Secondary	Adoption	What percentage of eligible providers participated and what percentage of patients completed study.	4 months
Secondary	Implementation	What was the rate of data collection and entry were completed by parents and reviewed by providers.	4 months

External Links

•   Foster Health Lab
•   Primary Investigator