Functional Recovery in Critically Ill Children

Functional Recovery in Critically Ill Children - the Wee-Cover Pilot Study

Intensive Care Unit-acquired weakness (ICU-AW) is a well-recognized, important and preventable sequelae of critical illness, affecting up to 60% of adult ICU patient. ICU-AW is associated with increased mortality and length of stay, and negatively impacts long-term functional outcomes and quality of life in affected patients and their caregivers. While delayed mobilization adversely affects clinical outcomes, early rehabilitation in the critically ill adult population is safe, feasible, cost effective, results in more ventilator free-days and better functional outcomes at hospital discharge. In contrast, there is a paucity of this research in pediatrics. Our research suggests that immobilization is common in critically ill children, and rehabilitation is delayed particularly in the sickest children who are arguably at highest risk of morbidity. It is unclear however, whether delayed rehabilitation leads to adverse outcomes in critically ill children, as has been demonstrated in adults. Our objectives of this study are to evaluate if immobilization and delayed rehabilitation negatively impacts short-term clinical outcomes and the time to functional recovery in critically ill children. The investigators hypothesize that the following factors may influence functional recovery and morbidity in critically ill children:

• Pre-morbid condition
• Age
• Time-to-initiation of acute rehabilitation
• Critical illness disease severity

Study Overview

• Status: Completed
• Conditions: Critical Illness; Children

Detailed Description

Overall Study objectives:

1. To describe the functional recovery following prolonged immobility and delayed rehabilitation in critically ill children.
2. To explore the predictors of impaired functional recovery following immobilization in critically ill children.

Prior to conducting a definitive multi-centre study to answer our research questions and achieve our study objectives above, we will conduct a pilot study in order to demonstrate feasibility.

• Study Type: Observational
• Enrollment (Actual): 30

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • McMaster Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically Ill Children

Description

Inclusion Criteria:

• Age over 12 months to 17 years
• PCCU stay of ≥ 48 hours
• Patient is limited to bed-rest and has not been mobilized during the first 48 hours of PCCU admission
• Equal to or greater than one organ dysfunction on PCCU admission (as measured by PELOD)
• Informed consent of patient/substitute decision maker.

Exclusion Criteria:

• Age: < 12 months or ≥18 years
• Patients admitted to step-down/intermediate care
• Patients transferred from Neonatal intensive care unit and never discharge home.

iv) Patients who are already mobilizing well, or are at baseline functional status at time of screening v) Admission diagnosis of a neuromuscular disorder: e.g. Acute Guillain-Barré Syndrome, Botulism, Myasthenia Gravis), or acute spinal cord injury/transverse myelitis vi) Not expected to survive PCCU/hospital stay vii) Previously enrolled into study less than 6 months ago and/or still undergoing study procedures at time of screening

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Observational Cohort; No Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional Recovery	Functional Recovery will be measured by the following standardized, validate pediatric assessment tools of function, as defined by the International Classification of Functioning, Disability and Health (ICF): 1) Pediatric Evaluation of Disability Inventory (PEDI); 2) Participation and Environment Measure - children and youth version (PEM-CY), and preschool version; 3) Pediatric Overall Performance Category score (POPC); 4) Pediatric Cerebral Performance Category Score (PCPC)	Baseline, 3 and 6 month follow-up
Pediatric Critical care Unit (PCCU) clinical outcomes	PCCU outcomes will be assessed by the following: Ventilator-free days, PCCU mortality, length of PCCU and hospital stay, and the incidence of PCCU-acquired weakness	at 30 days and duration of hospitalization
Muscle Strength	In an age-appropriate subgroup, the following measurements will be conducted: Muscle Strength and aerobic fitness testing (age ≥ 5 years, and/or able to cognitively and physically comply with strength and fitness tests); Measurement of muscle strength using BIODEX and hand grip strength, and assessment of lean mass (Bioelectrical impedance analysis)	Hospital discharge and at 3 and 6 month follow-up
Parental or caregiver stress	Parental or caregiver stress will be measured with the Parental Stress Index (PSI)	3 month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and reliability of screening for PCCU-acquired weakness	The most appropriate method of screening and diagnosing PCCU-acquired weakness has not been well established given the many challenges in ascertainment in this population. Hence, one of the objectives of this study is to determine whether manual muscle strength testing is a feasible and reliable method of screening for this important disorder in the critically ill pediatric population. Muscle strength will be quantified clinically using the (MRC) score by 2 independent assessors. For a subset of age appropriate (≥ 4 years), we will determine their hand-grip strength using a hand dynamometer or Martin Vigorimeter, depending on their age.	Duration of Hospitalization, 3 and 6 months follow-up

Collaborators and Investigators

• Sponsor: Karen Choong
• Investigators: Principal Investigator: Karen Choong, MB, BCh, MSc, McMaster University

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 30, 2012
• First Submitted That Met QC Criteria: November 7, 2012
• First Posted (Estimate): November 12, 2012

Study Record Updates

• Last Update Posted (Estimate): November 5, 2013
• Last Update Submitted That Met QC Criteria: November 3, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Keywords: functional recovery, critical illness, pediatrics
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: HHS REB No. 12-475