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    Study protocol for a two-center test of a nurse-implemented chronotherapeutic restoring bundle in critically ill children: RESTORE Resilience (R2)

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    Author
    Perry, Mallory A
    Dawkins-Henry, Onella S
    Awojoodu, Ronke E
    Blumenthal, Jennifer
    Asaro, Lisa A
    Wypij, David
    Kudchadkar, Sapna R
    Zuppa, Athena F
    Curley, Martha A Q
    Date
    2021-08-19
    Journal
    Contemporary Clinical Trials Communications
    Publisher
    Elsevier Inc.
    Type
    Article
    
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    Show full item record
    See at
    https://doi.org/10.1016/j.conctc.2021.100840
    Abstract
    Often, pediatric intensive care environments are not conducive to healing the sick. Critically ill children experience disruptions in their circadian rhythms, which can contribute to delayed recovery and poor outcomes. We aim to test the hypothesis that children managed via RESTORE Resilience (R2), a nurse-implemented chronotherapeutic bundle, will experience restorative circadian rhythms compared to children receiving usual care. In this two-phased, prospective cohort study, two separate pediatric intensive care units in the United Sates will enroll a total of 20 baseline subjects followed by 40 intervention subjects, 6 months to less than 18 years of age, requiring invasive mechanical ventilation. During the intervention phase, we will implement the R2 bundle, which includes: (1) a focused effort to replicate the child's pre-hospitalization daily routine, (2) cycled day-night lighting and sound modulation, (3) minimal yet effective sedation (RESTORE), (4) nighttime fasting with bolus enteral daytime feedings, (5) early progressive mobility (PICU Up!), (6) continuity in nursing care, and (7) parent diaries. Our primary outcome is circadian activity ratio post-extubation. We hypothesize that children receiving R2 will experience restored circadian rhythms as evidenced by decreased nighttime activity while in the PICU. Our exploratory outcomes include salivary melatonin levels; electroencephalogram (EEG) slow-wave activity; R2 feasibility, adherence, and system barriers; levels of patient comfort; exposure to sedative medications; time to physiological stability; and parent perception of being well cared for. This paper describes the design, rationale, and implementation of R2.
    Rights/Terms
    © 2021 Published by Elsevier Inc.
    Keyword
    Pediatric critical care
    Circadian rhythm
    Nurse-implemented interventions
    Mechanical ventilation
    Identifier to cite or link to this item
    http://hdl.handle.net/10713/16562
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.conctc.2021.100840
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