This is a prospective, observational study to investigate the agreement of the Leo device signal derivation with gold standard asthmatic testing in recently exacerbated asthmatic children. This study is designed for engineering validation of a wireless, wearable device (Leo) for assessing clinical control of children recovering from acute respiratory event such as asthma attack. The Leo device will monitor chest impedance, ECG and body position to calculate parameters such as respiration rate, heart rate, lung volume, tidal breathing flow and volume curves, and body position. These parameters will then be used to train and algorithm to assess clinical control of asthma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
30
After consent and enrollment, the child's respiratory impedance will be continuously recorded using the Leo device throughout the day and night during the entire hospital stay or ED visit. The device may be taken off for up to 1 hour per day (i.e., break during bath / shower time). The device will be applied to the skin overlying the mid-sternum area on the chest wall after cleaning of the skin with an alcohol swab after consent has been obtained. The device will be changed every 72 hours or earlier, by the participant's guardian, depending on signs of defect in the signal quality or battery exhaustion, based on daily check of the signal by the research team. Remote monitoring of the child's chest impedance will continue using the Leo device after discharge from hospital/ED for 7 days.
Children's Hospital Colorado
Aurora, Colorado, United States
RECRUITINGAirway resistance through oscillometry test
Asthma severity measures will be determined through oscillometry test at baseline and follow-up visit. Leo measurements will be assessed for agreement with oscillometry measures.
Time frame: Baseline visit and 7 days post hospital/ED discharge
Asthma Flare-up diary
Self-reported asthma flare-up diary score will be measured daily during the remote (at home) period in between visits.
Time frame: Follow-up for 7 days post hospital/ED discharge
CASI questionnaire
Questionnaire will be used to determine asthma severity during baseline and follow-up visit. CASI scores include five domains: day symptoms and albuterol use, night symptoms and albuterol use, controller treatment, lung function measures, and exacerbations. Range is from 0 -17, with a higher score indicating worse asthma severity
Time frame: Baseline visit and 7 days post hospital/ED discharge
Inhaler usage
Propeller sensor will include measures of time stamped data of inhaler usage (controller and rescue inhalers)
Time frame: Follow-up for 7 days post hospital/ED discharge
Tidal breathing from PNT device
Agreement and correlation in tidal breathing parameters between Leo and the pneumotachograph (PNT) device. The PNT device parameters are considered standard of care, and will be compared against Leo device to evaluate agreement.
Time frame: 7 days post hospital/ED discharge
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