Study Results
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View full resultsBasic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2017-09-05
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Intervention
R2 Bundle
R2 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.
Baseline
Usual care
No interventions assigned to this group
Interventions
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R2 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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
6 Months
17 Years
ALL
No
Sponsors
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Johns Hopkins University
OTHER
Children's Hospital of Philadelphia
OTHER
Boston Children's Hospital
OTHER
University of Pennsylvania
OTHER
Responsible Party
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Martha A.Q. Curley, PhD, RN
Principal Investigator
Principal Investigators
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Martha AQ Curley, RN, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania
Locations
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Johns Hopkins University - Charlotte Bloomberg Children's Center
Baltimore, Maryland, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Countries
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References
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Wieczorek B, Burke C, Al-Harbi A, Kudchadkar SR. Early mobilization in the pediatric intensive care unit: a systematic review. J Pediatr Intensive Care. 2015;2015(4):129-170. doi: 10.1055/s-0035-1563386. Epub 2015 Sep 3.
Pollack MM, Holubkov R, Funai T, Berger JT, Clark AE, Meert K, Berg RA, Carcillo J, Wessel DL, Moler F, Dalton H, Newth CJ, Shanley T, Harrison RE, Doctor A, Jenkins TL, Tamburro R, Dean JM; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Simultaneous Prediction of New Morbidity, Mortality, and Survival Without New Morbidity From Pediatric Intensive Care: A New Paradigm for Outcomes Assessment. Crit Care Med. 2015 Aug;43(8):1699-709. doi: 10.1097/CCM.0000000000001081.
Pollack MM, Holubkov R, Funai T, Clark A, Berger JT, Meert K, Newth CJ, Shanley T, Moler F, Carcillo J, Berg RA, Dalton H, Wessel DL, Harrison RE, Doctor A, Dean JM, Jenkins TL; Eunice Kennedy Shriver National Institute of Child Health and Human Development Collaborative Pediatric Critical Care Research Network. Pediatric intensive care outcomes: development of new morbidities during pediatric critical care. Pediatr Crit Care Med. 2014 Nov;15(9):821-7. doi: 10.1097/PCC.0000000000000250.
Hopkins RO, Choong K, Zebuhr CA, Kudchadkar SR. Transforming PICU Culture to Facilitate Early Rehabilitation. J Pediatr Intensive Care. 2015 Dec;4(4):204-211. doi: 10.1055/s-0035-1563547.
Kamdar BB, Niessen T, Colantuoni E, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Collop NA, Needham DM. Delirium transitions in the medical ICU: exploring the role of sleep quality and other factors. Crit Care Med. 2015 Jan;43(1):135-141. doi: 10.1097/CCM.0000000000000610.
Gehlbach BK, Chapotot F, Leproult R, Whitmore H, Poston J, Pohlman M, Miller A, Pohlman AS, Nedeltcheva A, Jacobsen JH, Hall JB, Van Cauter E. Temporal disorganization of circadian rhythmicity and sleep-wake regulation in mechanically ventilated patients receiving continuous intravenous sedation. Sleep. 2012 Aug 1;35(8):1105-14. doi: 10.5665/sleep.1998.
Huang HW, Zheng BL, Jiang L, Lin ZT, Zhang GB, Shen L, Xi XM. Effect of oral melatonin and wearing earplugs and eye masks on nocturnal sleep in healthy subjects in a simulated intensive care unit environment: which might be a more promising strategy for ICU sleep deprivation? Crit Care. 2015 Mar 19;19(1):124. doi: 10.1186/s13054-015-0842-8.
Hu RF, Jiang XY, Hegadoren KM, Zhang YH. Effects of earplugs and eye masks combined with relaxing music on sleep, melatonin and cortisol levels in ICU patients: a randomized controlled trial. Crit Care. 2015 Mar 27;19(1):115. doi: 10.1186/s13054-015-0855-3.
Kudchadkar SR, Aljohani OA, Punjabi NM. Sleep of critically ill children in the pediatric intensive care unit: a systematic review. Sleep Med Rev. 2014 Apr;18(2):103-10. doi: 10.1016/j.smrv.2013.02.002. Epub 2013 May 21.
Kudchadkar SR, Yaster M, Punjabi AN, Quan SF, Goodwin JL, Easley RB, Punjabi NM. Temporal Characteristics of the Sleep EEG Power Spectrum in Critically Ill Children. J Clin Sleep Med. 2015 Dec 15;11(12):1449-54. doi: 10.5664/jcsm.5286.
Oyarzun F. [Perception of a person's face and the process of personalization-depersonalization]. Actas Luso Esp Neurol Psiquiatr Cienc Afines. 1985 Mar-Apr;13(2):74-6. No abstract available. Spanish.
Aitken LM, Rattray J, Hull A, Kenardy JA, Le Brocque R, Ullman AJ. The use of diaries in psychological recovery from intensive care. Crit Care. 2013 Dec 18;17(6):253. doi: 10.1186/cc13164.
Jones C, Backman C, Capuzzo M, Egerod I, Flaatten H, Granja C, Rylander C, Griffiths RD; RACHEL group. Intensive care diaries reduce new onset post traumatic stress disorder following critical illness: a randomised, controlled trial. Crit Care. 2010;14(5):R168. doi: 10.1186/cc9260. Epub 2010 Sep 15.
Kamdar BB, Yang J, King LM, Neufeld KJ, Bienvenu OJ, Rowden AM, Brower RG, Collop NA, Needham DM. Developing, implementing, and evaluating a multifaceted quality improvement intervention to promote sleep in an ICU. Am J Med Qual. 2014 Nov-Dec;29(6):546-54. doi: 10.1177/1062860613509684. Epub 2013 Nov 22.
Kamdar BB, Knauert MP, Jones SF, Parsons EC, Parthasarathy S, Pisani MA; Sleep in the ICU (SLEEPii) Task Force. Perceptions and Practices Regarding Sleep in the Intensive Care Unit. A Survey of 1,223 Critical Care Providers. Ann Am Thorac Soc. 2016 Aug;13(8):1370-7. doi: 10.1513/AnnalsATS.201601-087OC.
Benloucif S, Burgess HJ, Klerman EB, Lewy AJ, Middleton B, Murphy PJ, Parry BL, Revell VL. Measuring melatonin in humans. J Clin Sleep Med. 2008 Feb 15;4(1):66-9.
Curley MA, Harris SK, Fraser KA, Johnson RA, Arnold JH. State Behavioral Scale: a sedation assessment instrument for infants and young children supported on mechanical ventilation. Pediatr Crit Care Med. 2006 Mar;7(2):107-14. doi: 10.1097/01.PCC.0000200955.40962.38.
Franck LS, Harris SK, Soetenga DJ, Amling JK, Curley MA. The Withdrawal Assessment Tool-1 (WAT-1): an assessment instrument for monitoring opioid and benzodiazepine withdrawal symptoms in pediatric patients. Pediatr Crit Care Med. 2008 Nov;9(6):573-80. doi: 10.1097/PCC.0b013e31818c8328.
Perry MA, Dawkins-Henry OS, Awojoodu RE, Blumenthal J, Asaro LA, Wypij D, Kudchadkar SR, Zuppa AF, Curley MAQ. Study protocol for a two-center test of a nurse-implemented chronotherapeutic restoring bundle in critically ill children: RESTORE Resilience (R2). Contemp Clin Trials Commun. 2021 Aug 19;23:100840. doi: 10.1016/j.conctc.2021.100840. eCollection 2021 Sep.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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828061
Identifier Type: -
Identifier Source: org_study_id
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