Restore Resilience in Critically Ill Children

Not Applicable

Completed

• Conditions: Acute Respiratory Distress Syndrome
• Interventions: Other: R2 Bundle

• Registration Number: NCT04695392
• Lead Sponsor: University of Pennsylvania

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-09-05
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Results First Submitted: 2022-11-18
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-26
• Last Update Submitted: 2024-04-26
• Results First Posted: 2024-04-30
• Last Update Posted: 2024-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• 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

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Exclusion Criteria

• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	R2 Bundle	R2 Bundle

Primary Outcome Measures

Name	Time	Method
DARE (Daytime Activity Ratio Estimate), Post Extubation	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.

Secondary Outcome Measures

Name	Time	Method
Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels	Day 5 of PICU hospitalization	Delta between average nighttime (19:00 to 06:59) and average daytime (07:00 to 18:59) salivary melatonin levels
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 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
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	Percentage of study days where the patient was not fed enterally after bedtime
Continuity in Nursing Care	From date of enrollment until the date of PICU discharge, assessed for up to 28 days	Continuity in Nursing Care Index (CINC) defined as (N nurses/N shifts)\*100. Score range 0-100, lower scores are better.
Pain Free Days	From date of PICU admission until the date of PICU discharge, assessed for up to 28 days	Percentage of PICU days where pain was assessed (0-10 pain scale) without pain (Pain score \<4)
Agitation Free Days	From date of PICU admission until the date of PICU discharge, assessed for up to 28 days	Percentage of PICU days without agitation (Agitation = State Behavioral Scale \[SBS; range -3 to +2\] \>/= 1)
Delirium Free Days	From date of PICU admission until the date of PICU discharge, assessed for up to 28 days	Percentage of PICU days, where delirium was assessed, without delirium (using the CAPD, pCAM-ICU or psCAM-ICU; cut score determined by instrument)
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	Highest daily mg/kg dose of all opioid sedative agents
Iatrogenic Withdrawal Syndrome (IWS) Free Days	From date of PICU admission until the date of PICU discharge, assessed for up to 28 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)
Parent Perception of Being well-cared-for	On the date of PICU discharge, assessed once within an average of 2 weeks post PICU admission	Percent match on the 7-item family-centered care scale (FCCS); range from 0-100% match; where higher scores indicate a better match
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 mg/kg dose of all opioid sedative agents received
Total PICU Days of Opioid Sedation	From date of PICU admission until the date of PICU discharge, assessed for up to 28 days	Total number of PICU days exposed to opioid sedation
PICU Length of Stay	From date and time of PICU admission until the date and time of PICU discharge	Time between the start and stop of PICU care
DARE (Daytime Activity Ratio Estimate), Acute Phase	From study enrollment to endotracheal 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.

Trial Locations

Locations (2)

Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

Johns Hopkins University - Charlotte Bloomberg Children's Center; 🇺🇸 Baltimore, Maryland, United States