NCT03573479|Completed
Early Rehabilitation in Critically Ill Children - The PICU Liber8 Study
PICULiber8
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PICULiber8
Sponsor study identifier
observational
130
1 country
2
Study Start
January 3, 2019
Actual (reported)Primary Completion
September 30, 2020
Actual (reported)Study Completion
October 30, 2020
Actual (reported)This is a pilot quality improvement implementation study that will measure the impact of a rehabilitation bundle implementation on the outcomes of interest. Advancements in the care provided in Pediatric Intensive Care Units (PICUs) have led to fewer deaths in children. These improvements are unfortunately countered by the emergence of side effects of critical illness, known as PICU-acquired complications (PACs). Delirium, muscle weakness, drug dependency and withdrawal are increasingly common. PACs occur because children are often over-sedated and experience long periods of immobilization. PACs delay recovery, increase disability and worsen long-term function and quality-of-life. Although they are preventable, PACs are very common and frequently overlooked by clinicians. This study aims to "liberate"children from critical illness and improve their recovery and functioning after discharge, through an innovative rehabilitation bundle of 8 complementary steps (PICU Liber8) to reduce sedation, allow children to awaken and breathe comfortably, encourage early mobilization, and engage families in their child's care.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 30, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2018
Actual (reported)June 29, 2018
Actual (reported)January 3, 2019
Actual (reported)September 30, 2020
Actual (reported)October 30, 2020
Actual (reported)Completion rate of daily goals (compliance)
The total number and percentage of daily goals completed from a pre-established daily goals checklist that assess compliance with the bundle. This is considered part of the feasibility outcomes group.
18 months
Performance of the bundle assessed with qualitative (i.e., narrative) description and comparison between groups.
Evaluation of performance as narrative description and comparison between periods of study, about the impact of the bundle on the process of quality of care. This also is part of the feasibility outcomes group.
18 months
Perceptions about barriers and facilitators for implementation of the bundle
Qualitative (i.e., narrative) assessment, description, and comparison of the perceptions from key stakeholders (i.e., family members, patients, clinicians, administrative personnel, nurse team, etc.) between groups about perceived barriers and facilitators for the adequate bundle's implementation. This belongs to the acceptability outcome.
This is the pre-implementation phase where a baseline documentation will take place about usual clinical practice, perceptions and attitudes of PICU staff and clinicians
After the implementation of the bundle (the PICU Liber8 components) same measurements will be captured and analyzed comparatively.
Bundle of elements for quality improvement
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients admitted to the PICU for the QI intervention. For patient follow-up we will conduct for patients at risk (see eligibility criteria)
Contact the study team to confirm eligibility.
McMaster Children's Hospital
Hamilton, Ontario, L8N 3Z5, Canada
Children's Hospital London Health Sciences
London, Ontario, Canada
Choong K, Koo KK, Clark H, Chu R, Thabane L, Burns KE, Cook DJ, Herridge MS, Meade MO. Early mobilization in critically ill children: a survey of Canadian practice. Crit Care Med. 2013 Jul;41(7):1745-53. doi: 10.1097/CCM.0b013e318287f592.
Cameron S, Ball I, Cepinskas G, Choong K, Doherty TJ, Ellis CG, Martin CM, Mele TS, Sharpe M, Shoemaker JK, Fraser DD. Early mobilization in the critical care unit: A review of adult and pediatric literature. J Crit Care. 2015 Aug;30(4):664-72. doi: 10.1016/j.jcrc.2015.03.032. Epub 2015 Apr 8.
Karen Choong, MD, MSc
McMaster University
130 participants (actual enrollment reported by the registry).
First Submitted
May 30, 2018
First Posted
June 29, 2018
Study Start
January 3, 2019
Actual (reported)Neuroinflammation During ICU-associated Delirium in Critically Ill Patients and Its Association With Structural and Functional Brain Alterations: a Nested Case-control Study
18 months
Economic analysis
18 months
Incidence of morbidities
18 months
Length of stay
1 month
Ventilator-free days at 30 days
1 month
30-day mortality
18 months
Choong K, Foster G, Fraser DD, Hutchison JS, Joffe AR, Jouvet PA, Menon K, Pullenayegum E, Ward RE; Canadian Critical Care Trials Group. Acute rehabilitation practices in critically ill children: a multicenter study. Pediatr Crit Care Med. 2014 Jul;15(6):e270-9. doi: 10.1097/PCC.0000000000000160.
Wieczorek B, Ascenzi J, Kim Y, Lenker H, Potter C, Shata NJ, Mitchell L, Haut C, Berkowitz I, Pidcock F, Hoch J, Malamed C, Kravitz T, Kudchadkar SR. PICU Up!: Impact of a Quality Improvement Intervention to Promote Early Mobilization in Critically Ill Children. Pediatr Crit Care Med. 2016 Dec;17(12):e559-e566. doi: 10.1097/PCC.0000000000000983.
Choong K, Fraser D, Al-Harbi S, Borham A, Cameron J, Cameron S, Cheng J, Clark H, Doherty T, Fayed N, Gorter JW, Herridge M, Khetani M, Menon K, Seabrook J, Simpson R, Thabane L. Functional Recovery in Critically Ill Children, the "WeeCover" Multicenter Study. Pediatr Crit Care Med. 2018 Feb;19(2):145-154. doi: 10.1097/PCC.0000000000001421.
Primary Completion
September 30, 2020
Actual (reported)Study Completion
October 30, 2020
Actual (reported)Last Updated
February 24, 2021
Record last verified: 2021-02
De-identified individual participant data will be collected from both participating sites and analyzed at the coordinating centre at McMaster.
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Source: ClinicalTrials.gov.
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