The study design will allow investigators to describe usual care in each PICU and identify the facilitating and restraining factors impacting the implementation of R2 at each PICU. The purpose of this pilot study is to improve the care, environment, daily routine and sleep patterns of children in the PICU. The goal of this study is to learn what can be improved to support a critically ill child's healing and circadian rhythms.
Hospitals should do the sick no harm. That noted, modern day pediatric intensive care units (PICUs) are not healing milieus. Immediately upon admission to the PICU, the child's daily routine and sleep patterns are replaced by a well-intended but not patient-centered PICU routine. The interprofessional investigative team believes that PICU care and environments can be modulated to sustain a young child's circadian rhythm (CR) and support their physiological resilience and capacity to heal. The first step in this program of research is to pilot-test RESTORE resilience (R2), a 7-item individualized bundle that we hypothesize will restore CR in critically ill children using a pre-posttest design. Two separate PICUs will each enroll 10 baseline subjects followed by 20 intervention subjects, 6 months to 18 years of age, who are intubated and mechanically ventilated for acute respiratory failure. Specifically, as soon as possible after PICU admission, parents will be interviewed to create an individualized chronotherapeutic bundle to include (1) focused effort to replicate the child's pre-hospitalization daily routine (bedtime/wake time, bedtime/arousal routine, nap time, feeding schedule, active periods), (2) cycled day-night lighting and modulation of sound to match the child's routine, (3) minimal yet effective sedation using a nurse-implemented goal-directed sedation plan (RESTORE), (4) night fasting with bolus enteral daytime feedings, (5) early, developmentally-appropriate, progressive exercise and mobility (PICU Up!), (6) continuity in nursing care, and (7) parent diaries. The overall objective of this study is to pilot-test an intervention that can be implemented in any PICU that will improve sleep-wake patterns with restoration/maintenance of circadian rhythms in critically ill children with acute respiratory failure. Results of this pilot study will be used to inform the design of an adequately powered multicenter randomized trial of R2.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
56
During the intervention phase subjects will receive R2. 1. Focused effort to replicate the child's pre-hospitalization daily routine (bedtime/wake time, bedtime/arousal routine, nap time, feeding schedule, active periods), 2. Cycled day-night lighting and modulation of sound to match the child's routine, 3. Minimal yet effective sedation using a nurse-implemented goal-directed sedation plan (RESTORE), 4. Night fasting with bolus enteral daytime feedings, 5. Early, developmentally-appropriate, progressive exercise and mobility (PICU Up!), 6. Continuity in nursing care, and 7. Parent diaries.
Johns Hopkins University - Charlotte Bloomberg Children's Center
Baltimore, Maryland, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
DARE (Daytime Activity Ratio Estimate), Post Extubation
DARE = Daytime Activity Ratio Estimate after endotracheal extubation; DARE was calculated by dividing daytime (07:00-18:59) activity count by 24-hour activity count. A DARE of 50% indicates equal amount of activity between daytime and nighttime periods (loss of circadian rhythm), while a higher DARE indicates increased daytime activity and nighttime sleep consolidation.
Time frame: From immediately after endotracheal extubation to PICU discharge, assessed for up to 28 days
Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels
Delta between average nighttime (19:00 to 06:59) and average daytime (07:00 to 18:59) salivary melatonin levels
Time frame: Day 5 of PICU hospitalization
Percentage of Study Days Where Light and Sound Were Modulated
Percentage of study days where light and sound were modulated to reflect day-night variation in light and sound levels; 0 = no study days where light and sound were modulated; 100% = light and sound modulated on all study days
Time frame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days
Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime
Percentage of study days where the patient was not fed enterally after bedtime
Time frame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days
Continuity in Nursing Care
Continuity in Nursing Care Index (CINC) defined as (N nurses/N shifts)\*100. Score range 0-100, lower scores are better.
Time frame: From date of enrollment until the date of PICU discharge, assessed for up to 28 days
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Pain Free Days
Percentage of PICU days where pain was assessed (0-10 pain scale) without pain (Pain score \<4)
Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
Agitation Free Days
Percentage of PICU days without agitation (Agitation = State Behavioral Scale \[SBS; range -3 to +2\] \>/= 1)
Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
Delirium Free Days
Percentage of PICU days, where delirium was assessed, without delirium (using the CAPD, pCAM-ICU or psCAM-ICU; cut score determined by instrument)
Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
Iatrogenic Withdrawal Syndrome (IWS) Free Days
Percentage of PICU days without IWS (Withdrawal Assessment Tool - version 1 \[WAT-1\]; range of scores 0-12 where no IWS = WAT-1 \< 3)
Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
Peak Daily Dose of All Opioid Sedative Agents
Highest daily mg/kg dose of all opioid sedative agents
Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
Cumulative Dose of All Opioid Sedative Agents
Total PICU mg/kg dose of all opioid sedative agents received
Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
Total PICU Days of Opioid Sedation
Total number of PICU days exposed to opioid sedation
Time frame: From date of PICU admission until the date of PICU discharge, assessed for up to 28 days
PICU Length of Stay
Time between the start and stop of PICU care
Time frame: From date and time of PICU admission until the date and time of PICU discharge
Parent Perception of Being well-cared-for
Percent match on the 7-item family-centered care scale (FCCS); range from 0-100% match; where higher scores indicate a better match
Time frame: On the date of PICU discharge, assessed once within an average of 2 weeks post PICU admission
DARE (Daytime Activity Ratio Estimate), Acute Phase
DARE = Daytime Activity Ratio Estimate after endotracheal extubation; DARE was calculated by dividing daytime (07:00-18:59) activity count by 24-hour activity count. A DARE of 50% indicates equal amount of activity between daytime and nighttime periods (loss of circadian rhythm), while a higher DARE indicates increased daytime activity and nighttime sleep consolidation.
Time frame: From study enrollment to endotracheal extubation