Acute Respiratory Distress Syndrome
Conditions
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.
Interventions
OTHERR2 Bundle
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.
Sponsors
University of Pennsylvania
Johns Hopkins University
Children's Hospital of Philadelphia
Boston Children's Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Pre-post study
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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 |
| 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 |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMartha AQ Curley, RN, PhD
University of Pennsylvania
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Baseline Usual care | 20 |
| Intervention RESTORE Resilience (R2), a 7-item individualized care bundle | 34 |
| Total | 54 |
Baseline characteristics
| Characteristic | Baseline | Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 20 Participants | 34 Participants | 54 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.2 years | 5.3 years | 3.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 18 Participants | 33 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 13 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 8 Participants | 17 Participants | 25 Participants |
| Region of Enrollment United States | 20 participants | 34 participants | 54 participants |
| Sex: Female, Male Female | 6 Participants | 14 Participants | 20 Participants |
| Sex: Female, Male Male | 14 Participants | 20 Participants | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 34 |
| other Total, other adverse events | 1 / 20 | 1 / 34 |
| serious Total, serious adverse events | 0 / 20 | 0 / 34 |
Outcome results
Primary
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
Population: Primary outcome not available for 4 subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | DARE (Daytime Activity Ratio Estimate), Post Extubation | 56.7 Percentage of total activity |
| Intervention | DARE (Daytime Activity Ratio Estimate), Post Extubation | 61.7 Percentage of total activity |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Agitation Free Days | 55 Percentage of study days |
| Intervention | Agitation Free Days | 50 Percentage of study days |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Continuity in Nursing Care | 67 units on a 0-100 scale |
| Intervention | Continuity in Nursing Care | 67 units on a 0-100 scale |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Cumulative Dose of All Opioid Sedative Agents | 12.2 mg/kg |
| Intervention | Cumulative Dose of All Opioid Sedative Agents | 7.6 mg/kg |
Secondary
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
Population: Data not available for all subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | DARE (Daytime Activity Ratio Estimate), Acute Phase | 53.3 Percentage of total activity |
| Intervention | DARE (Daytime Activity Ratio Estimate), Acute Phase | 62.0 Percentage of total activity |
Secondary
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
Population: Data not available for all subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Delirium Free Days | 74 Percentage of study days |
| Intervention | Delirium Free Days | 100 Percentage of study days |
Secondary
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
Population: Data not available for all subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels | -16.4 pg/mL |
| Intervention | Delta Between Average Nighttime and Average Daytime Salivary Melatonin Levels | 0.1 pg/mL |
Secondary
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
Population: Subjects still in the PICU on day 5 or later.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Iatrogenic Withdrawal Syndrome (IWS) Free Days | 100 Percentage of study days |
| Intervention | Iatrogenic Withdrawal Syndrome (IWS) Free Days | 100 Percentage of study days |
Secondary
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
Population: Data not available for all subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Pain Free Days | 80 Percentage of study days |
| Intervention | Pain Free Days | 74 Percentage of study days |
Secondary
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
Population: Data not available for all subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Parent Perception of Being well-cared-for | 100 Percent Match |
| Intervention | Parent Perception of Being well-cared-for | 100 Percent Match |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Peak Daily Dose of All Opioid Sedative Agents | 3.5 mg/kg/day |
| Intervention | Peak Daily Dose of All Opioid Sedative Agents | 2.9 mg/kg/day |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Percentage of Study Days Where Light and Sound Were Modulated | 0 Percentage of study days |
| Intervention | Percentage of Study Days Where Light and Sound Were Modulated | 100 Percentage of study days |
Secondary
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
Population: Data unavailable for all study subjects.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime | 43 Percentage of study days |
| Intervention | Percentage of Study Days Where the Patient Not Fed Enterally After Bedtime | 57 Percentage of study days |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | PICU Length of Stay | 7.0 days |
| Intervention | PICU Length of Stay | 7.1 days |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Baseline | Total PICU Days of Opioid Sedation | 6 days |
| Intervention | Total PICU Days of Opioid Sedation | 7 days |