Stopped: Non compliance from sponsor regarding applicable documentation to proceed with trial, therefore decision to permanently halt trial
The purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart rate, skin temperature, sleep, and activity) in the post surgical discharge period to identify trends which correlate with improved outcome and early recovery (return to baseline activity). These are measured (captured) utilizing a wearable technology (WT) device. Return to baseline (RTB) activity for the purpose of this study is defined primarily as step count normalization as a surrogate of activity (pre versus post operative step count), and heart rate variability normalization back to preoperative baseline. Increased heart rate variability has been studied in acute care settings as a marker of poor prognosis. Please note that return to baseline is not defined for the pediatric population in the same way as adults (which is primarily questionnaire based and not applicable in children).
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Change in circadian rhythm
Timeframe: 3 week
Change in circadian rhythm
Timeframe: 3 weeks
Change in activity
Timeframe: 3 week