Restore Resilience in Critically Ill Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 4
- 主要终点
- DARE (Daytime Activity Ratio Estimate), Post Extubation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PICU admission at one of the study sites in which elements of R2 are typically but sporadically implemented
- •Transferred to the PICU from another hospital unit/ward with ≤4 nights in the hospital (≤2 nights in PICU)
- •Between the ages 6 months and 18 years at the time of enrollment (has not had their 18th birthday)
- •Intubated and mechanically ventilated for acute airway or parenchymal disease within last 48 hours
- •Expected to be intubated for more than 12 hours past enrollment
- •Parent/Guardian providing consent, provides primary care for subject
排除标准
- •A baseline cognitive dysfunction, measured by the Pediatric Cerebral Performance Category (PCPC ≥4)
- •A history of an uncontrolled seizure disorder (seizure within past 3 months), cerebral hypertension, neuromuscular respiratory failure, ventilator dependence (excluding BiPAP or CPAP at night)
- •A history of inability to tolerate bolus enteral feeds (full J-Tube fed patients)
- •The presence of any of the following within 24 hours of admission:
- •Modal pain scores greater than 4
- •Persistent hypotension/hypertension unresponsive to standard therapies
- •Use of High Frequency Oscillatory Ventilation or Extracorporeal Membrane Oxygenation
- •Administered melatonin within the past week
- •Has an active do-not-resuscitate plan
研究组 & 干预措施
Baseline
Usual care
Intervention
R2 Bundle
干预措施: R2 Bundle (Other)
结局指标
主要结局
DARE (Daytime Activity Ratio Estimate), Post Extubation
时间窗: From immediately after endotracheal extubation to PICU discharge, assessed for up to 28 days
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.
次要结局
- Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels(Day 5 of PICU hospitalization)
- Percentage of Study Days Where Light and Sound Were Modulated(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(From date of enrollment until the date of PICU discharge, assessed for up to 28 days)
- Continuity in Nursing Care(From date of enrollment until the date of PICU discharge, assessed for up to 28 days)
- Pain Free Days(From date of PICU admission until the date of PICU discharge, assessed for up to 28 days)
- Agitation Free Days(From date of PICU admission until the date of PICU discharge, assessed for up to 28 days)
- Delirium Free Days(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(From date of PICU admission until the date of PICU discharge, assessed for up to 28 days)
- Iatrogenic Withdrawal Syndrome (IWS) Free Days(From date of PICU admission until the date of PICU discharge, assessed for up to 28 days)
- Parent Perception of Being well-cared-for(On the date of PICU discharge, assessed once within an average of 2 weeks post PICU admission)
- Cumulative Dose of All Opioid Sedative Agents(From date of PICU admission until the date of PICU discharge, assessed for up to 28 days)
- Total PICU Days of Opioid Sedation(From date of PICU admission until the date of PICU discharge, assessed for up to 28 days)
- PICU Length of Stay(From date and time of PICU admission until the date and time of PICU discharge)
- DARE (Daytime Activity Ratio Estimate), Acute Phase(From study enrollment to endotracheal extubation)
研究者
Martha A.Q. Curley, PhD, RN
Principal Investigator
University of Pennsylvania