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Completed

NCT Number: NCT01724593

Functional Recovery in Critically Ill Children

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

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Key information

Conditions

Critical Illness Children Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

12 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

McMaster Children's Hospital

Hamilton, Ontario, L8N 3Z5, Canada

About this study

Overall Study objectives:

  • To describe the functional recovery following prolonged immobility and delayed rehabilitation in critically ill children.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Feasibility

    Time frame: 12 months

    Feasibility will be determined by the consent and enrolment rate, and the protocol adherence and follow-up rates.

Secondary outcomes

  1. Functional Recovery

    Time frame: Baseline, 3 and 6 month follow-up

    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)

  2. Pediatric Critical care Unit (PCCU) clinical outcomes

    Time frame: at 30 days and duration of hospitalization

    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

  3. Muscle Strength

    Time frame: Hospital discharge and at 3 and 6 month follow-up

    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)

  4. Parental or caregiver stress

    Time frame: 3 month follow-up

    Parental or caregiver stress will be measured with the Parental Stress Index (PSI)

Other outcomes

  1. Feasibility and reliability of screening for PCCU-acquired weakness

    Time frame: Duration of Hospitalization, 3 and 6 months follow-up

    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.

Sponsors and collaborators

Lead sponsor

Karen Choong

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 12, 2012
Registry last updated
Nov 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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