Functional Recovery in Critically Ill Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Karen Choong, McMaster University
ClinicalTrials.gov Identifier:
NCT01724593
First received: October 30, 2012
Last updated: November 3, 2013
Last verified: November 2013
  Purpose

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

Condition
Critical Illness
Children

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Functional Recovery in Critically Ill Children - the Wee-Cover Pilot Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • Feasibility [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.


Secondary Outcome Measures:
  • Functional Recovery [ Time Frame: Baseline, 3 and 6 month follow-up ] [ Designated as safety issue: No ]
    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)

  • Pediatric Critical care Unit (PCCU) clinical outcomes [ Time Frame: at 30 days and duration of hospitalization ] [ Designated as safety issue: No ]
    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

  • Muscle Strength [ Time Frame: Hospital discharge and at 3 and 6 month follow-up ] [ Designated as safety issue: No ]

    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)

  • Parental or caregiver stress [ Time Frame: 3 month follow-up ] [ Designated as safety issue: No ]
    Parental or caregiver stress will be measured with the Parental Stress Index (PSI)


Other Outcome Measures:
  • Feasibility and reliability of screening for PCCU-acquired weakness [ Time Frame: Duration of Hospitalization, 3 and 6 months follow-up ] [ Designated as safety issue: No ]
    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.


Enrollment: 30
Study Start Date: October 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Observational Cohort
No Intervention

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.

  Eligibility

Ages Eligible for Study:   12 Months to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Critically Ill Children

Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01724593

Locations
Canada, Ontario
McMaster Children's Hospital
Hamilton, Ontario, Canada, L8N 3Z5
Sponsors and Collaborators
Karen Choong
Investigators
Principal Investigator: Karen Choong, MB, BCh, MSc McMaster University
  More Information

No publications provided

Responsible Party: Karen Choong, Associate Professor, McMaster University
ClinicalTrials.gov Identifier: NCT01724593     History of Changes
Other Study ID Numbers: HHS REB No. 12-475
Study First Received: October 30, 2012
Last Updated: November 3, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by McMaster University:
functional recovery, critical illness, pediatrics

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on October 01, 2014