Abstract Rationale Invasive home mechanical ventilation (IHMV) is critical for children with chronic respiratory failure. However, rapid liberation from the ventilator decreases cost and improves quality-of-life (QOL) for families and their children. Proactively decreasing IHMV support between clinic visits may hasten IHMV removal. This clinical trial tested whether integration of remote patient management (RPM) into routine clinical care could feasibly and safely facilitate adjustment of children’s HMV settings while promoting family and child QOL. Methods A single-arm, open-label clinical trial of RPM for chronic management of IHMV in children 0-17 years old was conducted (9/2023-10/2025; NCT06055413). Participation lasted for 4 months. To be eligible, patients must have been using IHMV while awake, had a condition for which weaning IHMV support was anticipated e.g., bronchopulmonary dysplasia (BPD), and lived with an English or Spanish-language family. Enrolled patient-parent dyads were provided with a RPM bundle including an electronic health record (EHR) patient-portal app, capnograph, and digital scale for their parent to measure and report objective information (e.g., vital signs, weight) and their child’s respiratory symptoms. RPM data were reviewed regularly in the EHR by the IHMV team to determine ventilator setting changes, if any. Pre-post comparisons of ventilator support and survey-based outcomes were evaluated using Wilcoxon signed-rank and McNemar’s tests. User feedback was analyzed using the System Usability Scale (SUS). Adverse events (AE) were tracked. Results Among the 64 eligible dyads, 50 consented of which 33 (66%) completed the intervention; 12 (24%) were lost-to-follow-up, and 5 (10%) withdrew. Among the final 33 dyads, median patient age was 1.9 years (interquartile range (IQR) 1.1,2.9); 18 (55%) of children used IHMV for BPD (Table 1). All parents spoke English; 56% were of minority race/ethnicity. RPM was used to make 69 ventilator setting changes mean 1.8 (SD ± 1.2)/patient. Median ventilatory support level decreased from 2902 L/kg/day (IQR 2376,3686) at baseline to 2450 L/kg/day (IQR 1935,3533) post-intervention (p 0.001). Parent SUS scores were 81.1 (SD ± 13.5) and clinician SUS scores were 71.3 (SD ± 4.3). Most parents (89%) and clinicians (100%) agreed that time spent on RPM was reasonable; 86% of parents and 75% of clinicians reported RPM fit into their routine. QOL pre/post intervention was not statistically different (p = 0.45). One AE resulted from a capnography miscalibration. Conclusions Implementation of RPM into chronic IHMV management was feasible with moderate patient reach. Participating children experienced safe reduction in ventilatory support with parents and clinicians reporting good RPM usability. This abstract is funded by: This study was funded in part by the National Heart, Lung, and Blood Institute (NHLBI) under 1K23HL149829-01A1. This study was funded in part by the Children’s Research Fund Junior Board, an Affiliated Organization of Ann & Robert H. Lurie Children’s Hospital of Chicago. Research Electronic Data Capture (REDCap) used in this study was supported at FSM by the Northwestern University Clinical and Translational Science (NUCATS) Institute, Research reported in this publication was supported, in part, by the National Institutes of Health’s National Center for Advancing Translational Sciences, Grant Number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NHLBI or NIH.
Foster et al. (Fri,) studied this question.