Home-based Optimization of Mechanical Ventilation in Children

Not Applicable

Recruiting

• Conditions: Ventilator Weaning
• Interventions: Other: Remote patient monitoring (RPM) bundle

• Registration Number: NCT06055413
• Lead Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-09-14
• Study Start: 2023-09-20
• Study First Submitted QC: 2023-09-20
• Study First Posted: 2023-09-26
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-09
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-05-01
• Study Completion: 2025-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intervention Arm	Remote patient monitoring (RPM) bundle	Patients receiving the intervention.

Primary Outcome Measures

Name	Time	Method
Level of ventilator support	4 months	Liters/kg/day

Secondary Outcome Measures

Name	Time	Method
Quality of life via participation	4 months	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.
Level of shared decision making	4 months	National Survey of Children's Health; shared decision-making survey questions
Cessation of awake positive pressure	4 months	Percentage of patients on any positive pressure ventilation during the day (per post discharge days)
Perceived access to ventilator care	4 months	Parent reported survey measure of their child's access to ventilator care
Child growth	4 months	Patient height and weight (absolute and Z scores)
Adoption	4 months	What percentage of eligible providers participated and what percentage of patients completed study.
Cessation of positive pressure	4 months	Percentage of patients on any positive pressure ventilation at any time (per post discharge days)
Ventilator management frequency	4 months	Number of ventilator management changes made per patient
Child healthcare utilization	4 months	Number of emergency department visits and hospitalizations.
Lung symptom control	4 months	Parent report using bronchopulmonary dysplasia survey measure
Reach	4 months	To what degree potential patient participants participated, defined by comparing how many were approached versus participated.
Implementation	4 months	What was the rate of data collection and entry were completed by parents and reviewed by providers.

Trial Locations

Locations (1)

Ann & Robert H. Lurie Children's Hospital of Chicago; 🇺🇸 Chicago, Illinois, United States